Yourlawyer.com (Defective Drugs News)

SSRI Antidepressant Patients Admitted to ICU Have Higher Death Rates

Wed, 23 May 2012 00:00:00 -0700

Yet another study is raising questions about the use of certain antidepressants, including selective serotonin reuptake inhibitor (SSRI) antidepressants. This time, research indicates that ICU patients who took SSRI antidepressants prior to admission have a higher rate of mortality, both while in the hospital and during the year after their hospital stay.

"Major depression is a common disorder affecting more than 16 percent of adults in the United States, and SSRI's are the most commonly prescribed medication class for this disease," said Katherine. M. Berg, MD, one of the physicians involved in the study, said in a statement. "The benefits of SSRI's for the treatment of depression are well documented. Due to the practical limitations of clinical trials, however, the long-term risks are unknown."

The study was conducted by a research team from Beth Israel Deaconess Medical Center in Boston and Massachusetts Institute of Technology (MIT). They looked at the records of 10,568 people that either died in the hospital or within a year of being in the ICU. Of that group, 1,876 had been taking either an SSRI antidepressant or a serotonin and norepinephrine reuptake inhibitor (SNRI).

According to the study, patients taking either type of antidepressant were 73 percent more likely to die either in the hospital or during the first year following their time in the ICU compared to the patients who weren't taking antidepressants. Among heart surgery patients, or those with heart problems, the mortality rate was double compared to other patient group.

Taking either type of antidepressant didn’t seem to affect all groups that were admitted to the ICU. For example, sepsis patients treated with the drugs did not have a higher death rate.

http://www.yourlawyer.com/topics/overview/ssri-antidepressants-birth-heart-defects-side-effects-lawsuit

Study Finds Bisphosphonate Fracture Risk Increases with Longer Use

Tue, 22 May 2012 00:00:00 -0700

For the second time in a week, a new study is raising serious concerns about long-term use of Fosamax and other bisphosphonates. The study, published in the Archives of Internal Medicine, confirmed a link between atypical thigh fractures and bisphosphonates, finding that the risk for such breaks increases the longer a patient uses the drugs.

The study, conducted by doctors at the University Hospitals of Geneva in Switzerland, looked at records of 477 patients ages 50 years and older treated at the hospital for certain kinds of broken legs between 1999 and 2010. Of those patients, 39 suffered atypical femur fractures, in which the thigh snaps apart with minimal or no trauma. Thirty-two of the 39 patients with such fractures had taken bisphosphonates. At two years, bisphosphonate users were 35 times more likely to suffer an atypical fracture. But by five to nine years, they were 117 times more likely to suffer such a break, and by nine years, the risk grew to 176 times more likely.

Robin Peter, an orthopedic surgeon at the Swiss hospital who helped write the study, told The Wall Street Journal the study’s findings indicate doctors should re-examine whether to keep patients on the drugs after three to five years. "Otherwise, it is possibly causing more harm than benefit," he said.

Just last week, an analysis conducted by the U.S. Food & Drug Administration (FDA) found that after about 3 to five years of use, bisphosphonates like Fosamax do little, if anything, to reduce the risk of fractures from osteoporosis. The FDA looked at two previously released studies that involved more than 2,400 post-menopausal women. One tracked Fosamax users for up to 10 years, while the other followed users of Reclast for six years. While women taking either Fosamax or Reclast experienced fewer fractures during the first three years of use compared to those taking a placebo, the gap narrowed after five and six years.

U.K. Regulators Issue Gilenya Heart Warning

Tue, 22 May 2012 00:00:00 -0700

Health officials in the United Kingdom are following a trend set by domestic regulators in issuing a health warning on the multiple sclerosis (MS) drug Gilenya (fingolimod) because it poses the risk of serious complications, especially for patients with prior heart trouble.

According to a release from the Medicines and Health Regulatory Agency (MHRA) in the U.K., Gilenya can cause transient bradycardias and heart block in patients shortly after taking the first dose of the drug. Gilenya is revolutionary in that is the first pill-form drug specifically designed to treat symptoms of MS, a debilitating nerve disease.

MHRA warns, like the Food and Drug Administration and other agencies like them have recently, that the first six hours after dispensing the first dose of the drug is crucial in determining whether a patient will suffer serious adverse side effects from Gilenya. The agency has recommended against prescribing the drug to patients who already suffer from heart complications, specifically a significant QT prolongation or a history or bradycardia, heart disease, heart failure, cerebrovascular disease, and uncontrolled high blood pressure.

It is advised that prescribing physicians monitor patients prior to, during, and after dispensing Gilenya for the first time. A sudden drop in heart rate is a key indicator that a patient is not reacting well to the drug. If a person’s heart rate drops during that six-hour period, the patient should be monitored even longer, and potentially for an overnight situation.

In an updated safety warning dispensed with Gilenya, MHRA is warning against prescribing the drug to patients with 2nd degree Mobitz Type II or higher degree atrioventricular block, sick sinus syndrome, or sino-atrial heart block, a “significant” QT prolongation, or those with a history of “symptomatic bradycardia” or ischaemic heart disease, or a history of myocardial infarction, heart failure, or cardiac arrest.

Patients taking drugs that lower the heart rate should also not be given Gilenya. For these patients, the drug should be dispensed very sparingly and only if other treatments for MS have failed. A doctor and patient should weigh the benefits of taking Gilenya versus its many drawbacks, especially for those with prior heart conditions.

During that first and key dose, patients should undergo a blood pressure test prior to taking the drug and then continuously through the first six hours. Another monitoring should occur after the six-hour window has closed.

Gilenya has been approved to treat relapsing forms of MS and is designed for patients who’ve not responded well to beta-interferon or their condition is severe and worsening quickly. There have been 15 cases of sudden death reported among people taking Gilenya, including several during the first dose. Many of the patients who died while taking Gilenya were suffering from a pre-existing cardiac condition, according to the agency’s release.

Health Canada Issues Actos Bladder Cancer Warning, Announces Label Update

Mon, 21 May 2012 00:00:00 -0700

Doctors and patients in Canada have been warned that taking Actos for more than a year may increase the risk of developing bladder cancer. In an alert issued last month, Health Canada said that Takeda Pharmaceuticals, the maker of Actos, had agreed to update the drug's Canadian label to warn of the potential for Actos bladder cancer side effects.

According to Health Canada:

Actos should not be used by patients who have or have had bladder cancer, or those who have blood or red color in their urine.
Patients taking Actos should seek medical attention if they begin to have red-colored urine, feel an increased need to urinate, or havepain while urinating, as these may be the symptoms of bladder cancer.
Doctors should evaluate potential Actos patients for bladder cancer risk factors before they start taking the medication, including smoking history, family bladder cancer history, workplace chemical exposure, cancer treatments, and radiation therapy.

Last June, the U.S. Food & Drug Administration (FDA) issued a safety communication stating that use of Actos for more than one year may be associated with an increased risk of bladder cancer. The June safety communication was a follow-up to one the agency issued in September 2010 after preliminary data from a study conducted by Kaiser Permanente demonstrated that the risk of bladder cancer rises with increasing dose and duration of Actos use, reaching statistical significance after 24 months. Bladder cancer concerns also caused regulators in France and Germany to suspend sales of Actos in those countries over the summer. Takeda officially recalled Actos from the French market in July.

FDA Comments on Z-Pak Sudden Death Risk

Fri, 18 May 2012 00:00:00 -0700

A study linking Zithromax (an antibiotic known generically as azithromycin, and popularly as Z-Pak) to an increased risk of sudden, heart-related deaths has caught the attention of the U.S. Food & Drug Administration (FDA). In a statement issued yesterday, the agency said it is reviewing the Zithromax study, and will communicate any new information that results from the Zithromax review.

The study, which was published in the New England Journal of Medicine, found that patients using the 5-day course of Z-Pak were twice as likely to die from sudden heart problems compared to those on amoxicillin, or those who took none. The highest risks were in Zithromax patients with existing heart problems.

According to the FDA, azithromycin belongs to a class of antibacterial drugs called macrolides, which have been associated with cardiovascular effects, including a type of abnormal heart rhythm which can be fatal. The "Warnings and Precautions" section of the Zmax drug label (azithromycin extended release for oral suspension) was revised in March 2012 to include new information regarding that risk. The drug labels for other macrolides, clarithromycin and erythromycin, also contain information about this possible side effect in the "Warnings" section. The FDA says it is s in the process of updating risk information in the drug labels for additional macrolide antibacterial drugs.

For now, the FDA says patients using Z-Pak should not stop without first talking to their doctors. Physicians should be aware that Zithromax and other macrolides have been associated with heart rhythm issues, the FDA said.

Acetaminophen Overdose Can Injure Liver

Wed, 16 May 2012 00:00:00 -0700

A recent local news report is emphasizing the dangers of possible acetaminophen overdose, an often overlooked risk posed by a common over-the-counter drug used by millions of people every day.

Acetaminophen, commonly taken under its brand name Tylenol, is a non-steroidal anti-inflammatory drug (NSAID), taken by people to treat minor to moderate pain and to reduce fever. Thought most likely purchased through a Tylenol product, acetaminophen is sold in myriad generic forms and is also an active ingredient in numerous other over-the-counter medications, such as cough-and-cold syrups and pills. The drug is available in prescription form but is taken by millions at over-the-counter strength doses, often several times daily.

According to a report from Salem (Mass.) News, a local pharmacy director at Salem Community Hospital explained to the source about the unforeseen dangers of acetaminophen, especially from overdoses of the drug. Dr. Keith Meredith explained that a majority of the public believes acetaminophen is safe and without risk.

In reality, acetaminophen poses serious risks to people of all ages, mostly through the risk of overdose. More specifically, people suffering from prior liver injuries, illness, or disease may be at an even greater risk of suffering a side effect of acetaminophen. The drug is metabolized by the liver and liver dysfunction impairs the body’s ability to absorb the drug, increasing the possibility of an overdose.

The Food and Drug Administration determined that the risk of acetaminophen overdose is great enough to reduce the maximum recommended dosage of the drug in a day, lowering it from 4,000 to 3,000 milligrams.

The pharmacy director interviewed for the report noted that people often accidentally overdose, not realizing they’re taking another drug simultaneously that also contains acetaminophen. For instance, a consumer may be taking a cough syrup to allay those symptoms but also taking Tylenol to reduce their fever. If that cough serum contains acetaminophen, the person taking it faces a risk of overdose.

There are numerous telltale signs someone is suffering from an acetaminophen overdose. The report notes abdominal pain, a loss of appetite, diarrhea, irritability, nausea, sweating, upset stomach, and vomiting as some of the less severe side effects, but those that could be early signs of trouble. More severe side effects that could appear without warning include coma, convulsions, and jaundice. Acetaminophen overdose can lead to liver injury and liver failure, and possibly death.

If someone is suspected of ingesting too much acetaminophen, they should seek immediate medical care. An antidote to an overdose can prevent liver failure if it is delivered quickly, within eight hours, after the drug is taken in excess.

Gilenya Subject to New FDA Restrictions

Tue, 15 May 2012 00:00:00 -0700

The U.S. Food & Drug Administration (FDA) warned yesterday that Gilenya should not be used in some patients, including those with certain pre-existing or recent heart conditions or stroke, or those taking certain medications to control abnormal heart rhythms. The new Gilenya restrictions follow the FDA's launch of a safety review in December, after the agency learned of one death that occurred within a 24 hours of a patient receiving a first dose of Gilenya.

According to the FDA, it was unable to determine if that death or other fatalities reported in postmarket or in clinical trials were related to Gilenya. However, the agency said it has concerns about the cardiovascular effects of the drug after the first dose.

Bradycardia, or slow heart rate, is one of the known side effects of Gilenya. The FDA said its safety review found that the heart rate lowering affects of Gilenya can occur within six hours of taking the first dose, as late as 20 hours after the first dose. As such, the agency is recommending:

All patients starting Gilenya be monitored for signs of a slow heart rate (bradycardia) for at least 6 hours after the first dose.
Recommending hourly pulse and blood pressure measurement for all patients starting Gilenya.
Electrocardiogram (ECG or EKG) testing should be performed prior to dosing and at the end of the observation period.
Cardiovascular monitoring should continue until any symptoms resolve, the FDA said.

The FDA also recommended that patients who develop severe bradycardia after the first Gilenya dose, bradycardia may be poorly tolerated, and certain other patient be monitored beyond 6 hours.

Study Points to Multiple Health Effects from SSRI Antidepressants

Tue, 15 May 2012 00:00:00 -0700

Another recent study has painted a grim picture on the safety and efficacy of popular antidepressant drugs like Prozac, Paxil, and Zoloft.

According to a report from UK’s The Daily Mail, a new study published in the journal Frontiers of Evolutionary Psychology notes that more people are learning of the negative effects of selective serotonin reuptake inhibitor (SSRI) drugs than they are the intended benefits.

SSRIs are often prescribed to treat mild and severe forms of depression, with millions of people taking the drugs to treat less serious symptoms. They work by boosting the levels of serotonin produced by the brain, thought to enhance better mood among the depressed.

This most recent study examines the results of previous studies and combines it with new research in the U.K. to find that many people on the drugs are finding no clinical benefits but a wide array of adverse side effects. In the study, the most commonly reported side effects were digestive problems, sexual dysfunctions, stroke, and even some cases of death. In some cases, the antidepressants had a reversal effect on patients, actually causing them to feel more depressed.

The study also cited another recent study that found SSRI antidepressants caused a 68 percent increased risk of causing birth defects when they’re taken by pregnant women or women about to become pregnant. Some birth defects commonly caused by antidepressants are cleft lip, cleft palate, and an increasing number of cardiac side effects.

Further, taking these drugs for longer periods of time can reduce their effectiveness and can cause a patient to relapse into the conditions the drugs were prescribed to treat.

Many elderly patients are prescribed SSRI antidepressants and most of these prescriptions are handed out to patients on an “off-label” basis, often given to patients suffering from symptoms of dementia despite them being proven to have no clinical benefit to those patients. In many elderly patients, SSRI antidepressants are believed to be the root of many problems and cause a 4 percent increased risk of death.

The new study does admit some fault, noting that researchers and physicians are still not exactly sure how they work on all parts of the body, including the brain and that many physicians rushed to prescribe the drugs because they proved to be at least partially effective at treating signs of depression.

Previous studies have indicated their effectiveness in patients with more severe forms of depression but recent research indicates these drugs are less effective or have no impact on a patient suffering from milder forms of it. The study concludes by urging physicians and patients to weigh all the potential risks of the drugs before prescribing them at-will to patients if they ask for them.

SlimQuick Eyed as Culprit in Young Woman's Liver Injury

Mon, 14 May 2012 00:00:00 -0700

A case study published last month in the World Journal of Hepatology has concluded that a young woman who suffered a severe liver injury was likely suffering from a side effect of the herbal weight loss supplement, SlimQuick. The authors of the report concluded that green tea extract contained in SlimQuick was the likely cause of her liver ailment.

Green tree extract, the primary ingredient in SlimQuick, contains epigallocatechin-3-gallate (EGCG), which has been linked to liver failure and liver damage in a number of studies. Previous research has indicated that drinking 3 to 5 cups of green tea per day provided at least 250 mg catechins per day and might be considered safe. According to the case study authors, their patient, a 24-year-old woman, had been taking two caplets of SlimQuick orally on an empty stomach twice per day for three months to improve energy for marathon training. The report authors calculated that the patient was exposed to green tea extract that contained catechin in amounts higher than suggested safe levels, especially in light of the fact that she was taking SlimQuick while fasting.

The woman presented to her primary care physician with complaints of dark urine, acholic stools, right upper quadrant pain and progressive fatigue. She took no other dietary supplements or medications except for oral tetracycline 500 mg/d for eleven months for acne. She stopped both drugs eight days after the onset of symptoms. Because the patient demonstrated no laboratory or clinical improvement three weeks after stopping SlimQuick and liver biopsy was consistent with marked inflammation with necrosis, treatment with Prednisone was initiated, according to the report.

The patient also suffered from heterozygous for alpha-1 antitrypsin deficiency, which might be a risk factor for chronic liver disease or liver failure. The study authors concluded that, in light of the patient’s baseline normal liver function, the likely presence of alpha-1 antitrypsin MZ phenotype increased her vulnerability to severe hepatocellular injury. Tetracycline-induced liver injury was excluded as an offender based on the histopathology, leaving SlimQuick as the likely hepatotoxic agent.

Bisphosphonates May be Less Effective in Preventing Fractures after Five Years

Thu, 10 May 2012 00:00:00 -0700

A new study published in the New England Journal of Medicine is raising new concerns about the efficacy of long-term bisphosphonate therapy. The analysis, which was conducted by the U.S. Food & Drug Administration (FDA), found that after about 3 to five years of use, bisphosphonates like Fosamax do little, if anything, to reduce the risk of fractures from osteoporosis.

In conducting the bisphosphonate analysis, the FDA looked at two previously released studies that involved more than 2,400 post-menopausal women. One tracked Fosamax users for up to 10 years, while the other followed users of Reclast for six years. While women taking either Fosamax or Reclast experienced fewer fractures during the first three years of use compared to those taking a placebo, the gap narrowed after five and six years.

The report didn't include guidance about long-term use, stating that an individual's risk should be discussed with their doctor. However, the agency did say that women at low risk for fracture or with a bone density near normal may be good candidates to stop therapy after three to five years, while older patients at higher fracture risk and bone density “in the osteoporotic range” may benefit from continued therapy.

An accompanying editorial asserted that women most likely to benefit from long-term bisphosphonate therapy are those who continue to have very low bone density, as measured by something called a “T score” that is lower than minus 2.5 after three to five years of treatment. Those with a history of spinal fracture or with an existing fracture also are most likely to benefit from long-term use of the drugs, the researchers concluded.

Proton Pump Inhibitors Signicantly Increase Risk of C-Diff

Thu, 10 May 2012 00:00:00 -0700

A new comprehensive study of the effects of Proton Pump Inhibitor (PPI) drugs like Nexium, Prevacid, Prilosec, and Protonix has revealed their association with a greater risk of the life-threatening Clostridium difficile infection (C-diff. or CDI).

According to a report at FamilyPracticeNews.com, researchers at the European Congress of Clinical Microbiology and Infectious Diseases have discovered a “robust association” between the popular and widely-prescribed class of drugs most often used to treat conditions like heartburn, acid reflux disease, and other similar issues. The study adds that “most” use of these drugs is unjustified and providing only more risks than benefits to a recipient.

For the study, researchers used the results of 30 previously conducted reviews of PPI drugs and conducted a systematic review and meta-analysis to reach its conclusions. The studies were required to have been looking for a link between taking PPI drugs and CDI and 30 studies published by the end of January were included, from the U.S., U.K., Canada, and Israel. This latest study included those which looked at the risks associated with community-acquired CDI, hospital-acquired CDI, or both.

They believe the results of this study will have global impact on future prescriptions written for PPI drugs. In addition to this specific risk, PPI drugs - especially when used for long periods of time - have been associated with risks of bone fractures, specifically of the hips and wrists. According to the report, the study found that PPI drugs “significantly increased risk for CDI, with an odds ratio of 1.58 (95% confidence interval [CI], 1.38-1.80). The pooled proportion of CDI patients who were exposed to antibiotics was 0.70 (95% CI, 0.64-0.75).”

Earlier this year, the Food and Drug Administration issued an alert similar to the worries expressed through this latest study, warning that taking PPI drugs likely increased a person’s risk of developing C-diff infection.

In breaking down the studies further, researchers were able to determine that a patient’s location and exposure to antibiotics while taking PPI drugs likely increased their risk of developing CDI over a factor like gender. Higher risks were noted in Canadian and Israeli studies than from those conducted in the U.S. and U.K. Unpublished studies also impacted the risk factors associated with PPI drugs.

This study was still not able to determine exactly why PPI drugs were associated with this increased risk of C-diff infections. Possible reasons for the risk factors, theorized by the study researchers, included the facts that PPI drugs do not kill the “vegetative” form of the infection and the drugs also impair “gastric emptying,” a condition that improves the growth of the vegetative form of CDI.

Louisiana Man Files Medtronic Infuse Lawsuit Following Off-Label Spine Surgery

Tue, 08 May 2012 00:00:00 -0700

A lawsuit has been filed in Louisiana by a man who allegedly suffered complications following an off-label spine procedure with Medtronic Inc.'s Infuse Bone Graft. The lawsuit, filed in U.S. District Court for the Eastern District of Louisiana, alleges the use of Infuse in a transforaminal lumber interbody fusion resulted in painful, unwanted bone growth along the plaintiff's spine.

As we've reported previously, it's thought that roughly 85% of the producers that have involved Infuse are off-label uses. In July 2008, the U.S. Food & Drug Administration (FDA) warned that Infuse and similar bone growth products had caused serious, sometimes life threatening complications, when used in off-label in spinal procedures. The FDA approved Infuse, which is made with a genetically engineered material called rhBMP-2 (recombinant human Bone Morphogenetic Protein-2), 2002 for use in one type of spine surgery called anterior approach lumbar fusion, and two types of dental surgeries.

The plaintiff named in the Louisiana complaint received Infuse in February 2011. Following the procedure, the plaintiff claims he was led to believe his back pain following his initial surgery was the result of the underlying medical condition that necessitated surgery. In early 2012, however, he learned that Medtronic Infuse has been associated with unwanted bone growth, which can lead to nerve impingement.

The lawsuit alleges that because of his Medtronic Infuse operation, the plaintiff has required epidural spinal injections, physical therapy and the need for additional surgery to implant a transcutaneous electrical nerve stimulator (TENS) unit to ease his pain.

Abbott Labs Settles Depakote Marketing Charges with Justice Department

Tue, 08 May 2012 00:00:00 -0700

Abbott Labs has entered a guilty plea and agreed to pay $1.5 billion to settle charges with the U.S. Department of Justice (DOJ) regarding its marketing of Depakote. Federal prosecutors had alleged that Abbott illegally promoted Depakote for uses not approved as safe and effective by the Food and Drug Administration (FDA).

According to a press release issued by the DOJ yesterday, the Depakote settlement includes a criminal fine and forfeiture totaling $700 million. Another $800 million will go towards civil settlements with the federal government and the states. Abbott also will be subject to court-supervised probation and reporting obligations for Abbott’s CEO and Board of Directors, the DOJ said.

The FDA approved Depakote for epileptic seizures, bipolar mania and the prevention of migraines. But according to the DOJ, Abbott trained its sales force to promote Depakote to health care providers and employees of nursing homes as advantageous over antipsychotic drugs for controlling agitation and aggression in elderly dementia patients. At the time, Depakote was not subject to certain provisions of the Omnibus Budget Reconciliation Act of 1987 (OBRA) and its implementing regulations designed to prevent the use of unnecessary medications in nursing homes. Abbott sales representatives stated that by using Depakote, nursing homes could avoid the administrative burdens and costs of complying with OBRA, the DOJ said.

In 1999, Abbott was forced to discontinue a clinical trial of Depakote in the treatment of dementia due to an increased incidence of adverse events, including somnolence, dehydration and anorexia experienced by the elderly study participants administered Depakote.

“Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and downplayed the risks apparent from its own clinical studies,” said Acting Associate Attorney General Tony West.

According to the DOJ statement, Abbott also admitted that from 2001 through 2006, it misbranded Depakote by marketing the drug to treat schizophrenia. Abbott funded two studies of the use of Depakote to treat schizophrenia, and both failed to meet the main goals established for the study. Abbott waited nearly two years to notify its own sales force about the results of the second study and another two years to publish those results. During this time, Abbott continued to promote Depakote off-label to treat schizophrenia, federal prosecutors say.

Parker Waichman LLP Files Nine Plavix Bleeding Side Effect Lawsuits

Fri, 04 May 2012 00:00:00 -0700

Parker Waichman LLP continues to file Plavix lawsuits on behalf of people who allegedly suffered serious internal bleeding and other Plavix side effects. In the past week alone, Parker Waichman LLP filed nine Plavix side effect claims in the Supreme Court of New York, New York County.

Six lawsuits filed by the firm on April 30 allege Plavix caused plaintiffs to suffer several side effects, including hemorrhage, cerebral hemorrhage and thrombotic thrombocytopenic purpura (TTP), a blood condition which is marked by small clots through the entire circulatory system. Three additional lawsuits filed on May 3 claim plaintiffs suffered gastrointestinal bleeds from Plavix.

Among other things, the complaints allege that Bristol-Myers Squibb and Sanofi-Aventis, the makers of Plavix, negligently and/or fraudulently represented that Plavix had been tested and was found to be safe and/or effective for its indicated use. The lawsuits further charge that the Defendants concealed their knowledge of Plavix defects from the Plaintiffs, the FDA, the public in general and/or the medical community specifically.

Plavix is often prescribed with a low dose of aspirin. Its makers claim it is more effective than regular aspirin alone preventing heart attack and stroke caused by blood clots. Since its 1997 approval, Plavix has ranked among the best selling drugs in the U.S.

Conflicting Bisphosphonate Studies Raise Esophageal Cancer Worries

Thu, 03 May 2012 00:00:00 -0700

In 2010, two studies on oral bisphosphonates reached differing conclusions regarding the drugs’ association with an increased risk of esophageal cancer. One study, published in the Journal of the American Medical (JAMA) Association, found no increased risk for esophageal cancer among patients who used oral bisphosphonates like Fosamax. Three weeks later, the second study, which found a doubling of the risk, appeared in the British Medical Journal.

Strangely enough, both bisphosphonate esophageal cancer studies drew data from the same source - a U.K. patient data base. So why the different conclusions?

According to a report published in The Wall Street Journal, the answer could lie in the way the studies were conducted. Both were observational studies, in which the researchers analyzed previously gathered data and drew conclusions, the Journal said. Observational studies are not considered the told standard in medical research - that distinction belongs to randomly controlled experimental studies. For one thing, observation studies are vulnerable to bias. Their conclusions usually are not easy to replicate, and flaws are usually not spotted - or corrected - when observational studies are published. Yet this research method is increasingly popular, possibly in part to their lower cost compared to experimental studies.

According to the Journal, both bisphosphonate esophageal cancer studies suffered from flaws. In the JAMA study, oral bisphosphonate users were identified first, then matched to random people of the same sex and age in the population, and then tracked until some developed cancer. The authors of the study acknowledge that their work has less statistical power than the BMJ paper, and that "poorly measured or unmeasured causes of bias may have masked an association" between the drugs and cancer.

In the JAMA, cancer cases were identified first, and then researchers looked at the drugs subjects had been given in the past. According to the Journal, the study suffered because it reported on three different variables at once, which could introduce errors due to "multiple testing." The study's lead author told the Journal the team did not adjust for multiple testing, and she acknowledged that because information about the patients isn't consistent, "this database may not be the ideal place to look," the Journal said.

It could also turn out that neither study has any validity because they both followed patients for less than five years. The findings of both would be rendered useless if it turns out that esophageal cancer develops after longer periods of bisphosphonate years, say 10 years or more.

Parker Waichman Representing West Virginia Man in Actos Bladder Cancer Lawsuit

Tue, 01 May 2012 00:00:00 -0700

Parker Waichman LLP has filed another Actos bladder cancer lawsuit, this time on behalf of a West Virginia man who developed the disease after taking Actos for several years. The lawsuit alleges that Defendants, Takeda Pharmaceuticals and Eli Lilly, promoted Actos as a safe and effective treatment for type II diabetes, even though they knew or should have known that taking Actos for longer than 12 months increased the risk of bladder cancer.

This latest Actos bladder cancer lawsuit was filed by Parker Waichman in the Western District of Louisiana as part of In Re: Actos (Pioglitazone) Products Liability Litigation (MDL 2299). Jerrold S. Parker, founding partner of Parker Waichman LLP, has been appointed to the Plaintiffs' Steering Committee in the Actos Litigation.

According to the complaint, the Plaintiff developed bladder cancer several years after he was prescribed and began taking Actos in 2005. The lawsuit alleges that because of his use of Actos, the Plaintiff sustained severe, permanent and life-threatening personal injuries, pain, suffering, emotional distress, and lifelong fear of premature death. It further alleges that because of his use of Actos, the Plaintiff will require continued lifelong monitoring, treatment and medications.

This past June, the U.S. Food & Drug Administration (FDA) issued a safety communication stating that use of Actos for more than one year may be associated with an increased risk of bladder cancer. The June safety communication was a follow-up to one the agency issued in September 2010 after preliminary data from a study conducted by Kaiser Permanente demonstrated that the risk of bladder cancer rises with increasing dose and duration of Actos use, reaching statistical significance after 24 months. Bladder cancer concerns also caused regulators in France and Germany to suspend sales of Actos in those countries over the summer. Takeda officially recalled Actos from the French market in July.

Bayer Says 651 Yaz, Yasmin Blood Clot Lawsuits Have Been Settled

Fri, 27 Apr 2012 00:00:00 -0700

Bayer AG continues to settle lawsuits alleging its Yaz and Yasmin birth control pills caused serious, life-threatening blood clots in some young women. According to the company's latest Stockholder Newsletter, Yaz and Yasmin lawsuit settlements have cost the company $142 million so far.

According to Bayer, some 651 lawsuits have been resolved.

“Bayer is only settling claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism) after a case specific analysis of medical records,” the company's report said.

According to a report from Bloomberg News, around 14,000 plaintiffs have filed 11,900 lawsuits over Yaz and Yasmin. About half of the lawsuits allege the drugs caused blood clots that can lead to heart attacks, strokes and even death. Bayer has not indicated a willingness to settle other claims, such as those alleging use of Yaz and Yasmin led to gallbladder disease.

Most of those lawsuits are pending in a multidistrict litigation under way in Illinois federal court alleging that Yaz and Yasmin caused serious side effect injuries, including blood clots. Late last year, the first trials in that litigation, which were scheduled to start in January, were postponed, and the cases were ordered to mediation at Bayer's request.

Earlier this month, the U.S. Food & Drug Administration (FDA) announced that the labels for Yaz, Yasmin and similar birth control pills would be updated to include additional information regarding blood clots, after its review of observational studies indicated that oral contraceptives made with drospirenone might pose a higher risk of blood clots compared to those made with other forms of progestin.

More Harm than Good from SSRI, Other Antidepressants, Study Finds

Thu, 26 Apr 2012 00:00:00 -0700

A group of Canadian researchers says the risks of antidepressants - including selective serotonin reuptake inhibitor (SSRI) antidepressants - outweigh their benefits. In a study published in the journal Frontiers in Psychology, the researchers conclude that the antidepressants are probably doing more harm than good, and use of the drugs should be reconsidered.

The study, a review previous research into the effects of antidepressants conducted by scientists at McMaster University in Canada, discovered that antidepressants which impact levels of serotonin in the brain can cause side effects related to any bodily process normally regulated by serotonin. These types of drugs would include SRI antidepressants, such as Paxil, Prozac, Celexa, Lexapro, as well as norepinephrine serotonin reuptake inhibitors such like Effexor and Strattera.

Among other things, the study linked use of these antidepressants to birth defects, sexual problems, digestive problems, and a higher risk of bleeding and stroke in elderly patients. The study authors also reviewed three recent studies showing that elderly antidepressant users are more likely to die than non-users, even after taking other important variables into account.

"Serotonin is an ancient chemical," lead research and evolutionary biologist, Paul Andrews, said in a statement. "It's intimately regulating many different processes, and when you interfere with these things you can expect, from an evolutionary perspective, that it's going to cause some harm."

Andrews and his research team believe that the use of antidepressants could decline as more is learned about their side effects.

"It could change the way we think about such major pharmaceutical drugs," Andrews said in a statement issued by McMaster. "You've got a minimal benefit, a laundry list of negative effects – some small, some rare and some not so rare. The issue is: does the list of negative effects outweigh the minimal benefit?"

Parker Waichman LLP Calls on FDA to Compel Actos Bladder Cancer Warning from Takeda

Thu, 26 Apr 2012 00:00:00 -0700

Parker Waichman LLP has called on the U.S. Food & Drug Administration (FDA) to compel Takeda Pharmaceuticals to issue its own notification to doctors regarding the association between long-term use of Actos and bladder cancer. The firm was prompted by Takeda Canada's issuance of a "Dear Healthcare Professional" letter in Canada detailing Actos' link to bladder cancer, and informing recipients of changes being made to the Actos label in that country.

The Actos letter was issued by Takeda Canada in collaboration with Health Canada, the country's drug regulator. The document, dated April 16, states that: "Health Canada has recently completed a safety assessment of the available data and the Product Monograph (PM) was updated to reflect the potential risk of bladder cancer in treated patients." Among other things, the modified label will acknowledge that findings from new studies reveal that there is a potential increased risk of bladder cancer in patients treated with pioglitazone-containing products. In addition to being sent to Canadian healthcare professionals, a copy of the letter was posted to Health Canada's website.

When the FDA issued a warning regarding long-term use of Actos and bladder cancer last June, no such statement directed at U.S. healthcare providers was forthcoming from Takeda. Parker Waichman LLP believes the FDA should have required such a statement from the drug maker, and is pressing it to compel Takeda to release one now.

“We are hopeful that the FDA will take the strongest action possible to protect patients by requiring Takeda to directly notify the physicians of serious adverse events associated with taking Actos,” Daniel Burke, an attorney at Parker Waichman LLP, said in statement issued by the firm.

Gilenya Warnings Updated Following Sudden Death Reports

Mon, 23 Apr 2012 00:00:00 -0700

Following safety reviews in the U.S. and Europe, Novartis said it has agreed to add additional label warnings to its multiple sclerosis drug, Gilenya. The Gilenya safety reviews were launched in response to reports of sudden death among patients treated with Gilenya.

According to statements from the company, the labels for Gilenya in the U.S. and Europe will now recommend that all patients have an electrocardiogram (ECG) before taking their first dose of the drug. In addition, the U.S. label will advise that those starting treatment with Gilenya are also advised to get a second ECG six hours after their first dose of the medication. However, the Gilenya label in Europe will recommend continuous ECG monitoring for a minimum of six hours following the first dose.

Both labels will advise against the use of Gilenya in patients with a history of cardiovascular and cerebrovascular disease or who take heart-rate lowering medication. When treatment with Gilenya is necessary in these patients, their heart activity should be monitored at least overnight after the first dose, Novartis said.

The U.S. Food & Drug Administration (FDA) announced a Gilenya safety review last December, after one patient died within 24 hours of taking their first dose of Gilenya. European regulators started their review in January, after receiving reports of 10 additional deaths among Gilenya patients. According to the drug’s maker, Novartis AG, six of those deaths were unexplained, three resulted from heart attacks and one was due to disruption of heart rhythm.

In announcing these label modifications, the European Medicines Agency said it had reviewed a total of 15 cases of sudden or unexplained deaths in Gilenya patients. “Most of the deaths and cardiovascular problems had occurred in patients with a history of cardiovascular problems or taking other medicines,” the regulator said. “However, the data reviewed were not conclusive as to whether Gilenya was the cause of the deaths.”

Health Canada Announces Actos Bladder Cancer Warning

Mon, 23 Apr 2012 00:00:00 -0700

Canadians are now being officially warned about the risks of bladder cancer associated with taking the Type 2 diabetes drug Actos.

According to The Canadian Press, Health Canada and Takeda Canada have issued a statement alerting the public there about this specific risk now being linked to this top-selling diabetes drug treatment. This statement follows others issued elsewhere around world, including the U.S. where many Actos users have already begun developing bladder cancer and have filed lawsuits against Takeda Pharmaceuticals for failing to warn of this side effect.

Actos is a top-selling treatment for Type 2 diabetes. It has supplanted a previous drug, Avandia, atop the market after that drug was found to carry its own set of serious and life-threatening side effects and because attention was mostly focused on Avandia’s woes, research on the effects of Actos had largely gone unnoticed or unfinished. Now that it’s topping the market and so many people taking Actos in place of Avandia, more attention is being drawn to its side effects.

Though this warning comes a few months after other statements made on Actos’ link to bladder cancer, the report indicates the drug had already fallen out of favor in Canada. A researchers at Toronto’s St. Michael’s Hospital said many doctors have been taking patients off Actos for several years so the warning doesn’t come as much of a surprise.

Furthering this theory is the fact that Actos has been placed in a group of drugs in the province of Ontario listed as “exceptional access” meaning only select patients can receive it, usually only those who’ve gotten clinical benefit from the drug in the past. In most cases, Actos should not be considered the go-to treatment, especially initially, for treating Type 2 diabetes.

In Health Canada’s statement, it cites an ongoing clinical trial of Actos being conducted by Takeda, the makers of the drug. In that study, patients not taking the drug have developed bladder cancer at a rate of 7 in 10,000 patients. Those taking Actos developed the mostly irreversible disease at the rate of 10 in 10,000.

The agency also notes that people taking Actos for longer periods of time appear to be facing the greatest risk of developing bladder cancer. People currently suffering from bladder cancer or have a history of bladder cancer in their family should also avoid taking Actos, Health Canada warned.

Physicians can determine who is most at risk of bladder cancer by considering several factors, including family history, whether the patient is a smoker or is exposed to some chemicals or radiation in the workplace.

Novartis Updating Tekturna Label with Warnings for Diabetes, Kidney Patients. Announces Valturna Market Withdrawal.

Fri, 20 Apr 2012 00:00:00 -0700

Novartis has announced that it will be making changes to the labels for Tekturna and other aliskiren-based medications regarding serious risks posed by such drugs when they are used by diabetics or patients with kidney failure who are also taking ACE Inhibitors or angiotensin receptor blockers (ARBs). Novartis also said it will pull the drug Valturna, a single pill combination of aliskiren and the ARB valsartan, from the U.S. market by July 20, 2012.

According to a statement from Novartis, the company is taking these actions at the request of the U.S. Food &Drug Administration (FDA), which has completed a preliminary review of its halted ALTITUDE study. This past December, Novartis announced ALTITUDE had been halted after an independent review committee noted higher adverse events in patients receiving aliskiren in addition to either an ARB or ACE inhibitor. There was also an increased incidence after 18-24 months of serious side effects in the high risk population, including non-fatal stroke, kidney complications, hyperkalemia, and hypotension.

The modified Tekturna labels will warn against:

The combined use of aliskiren-based products with ACE Inhibitors and angiotensin receptor blockers (ARBs) in patients with diabetes.
A warning against the use of aliskiren-based products in patients with moderate renal (kidney) impairment (eGFR < 60 ml/min) who are also taking an ACE inhibitor or an ARB.

In addition to Tekturna, the new warnings will be added to:

Tekturna HCT(aliskiren and hydrochlorothiazide)
Tekamlo(TM) (aliskiren and amlodipine)
Amturnide(TM) (aliskiren, amlodipine and hydrochlorothiazide)

Patients who take Valturna are being advised to discuss alternative treatments with their doctors before July 20, 2012.

PPIs May Impact Magnesium Levels, Cause Fractures, U.K. Drug Regulator Warns

Fri, 20 Apr 2012 00:00:00 -0700

Patients in the U.K. are being warned that prolonged use of proton pump inhibitors (PPI) may be associated with an increased risk of fractures, as well as a condition called hypomagnesaemia. The U.K.'s Medicines and Healthcare Regulatory Agency (MHRA), has issued guidance to doctors and patients there regarding these possible PPI side effects.

Hypomagnesaemia is an electrolyte disturbance in which there is an abnormally low level of magnesium in the blood. Left untreated, this condition can lead to cardiac and respiratory arrest, and even death. Symptoms of the condition may include:

•    Abnormal eye movements (nystagmus)
•    Convulsions
•    Fatigue
•    Muscle spasms or cramps
•    Muscle weakness
•    Numbness

According to the MHRA, a review of case reports described in the literature or reported to regulatory authorities in Europe suggests that PPIs may cause hypomagnesaemia. Some cases occurred after 3 months of PPI therapy, but most occurred after 1 year of treatment.   Doctors are being advised to consider measurement of magnesium levels before starting PPI treatment and periodically during prolonged treatment, especially in those who will take a PPI concomitantly with digoxin or drugs that may cause hypomagnesaemia (eg, diuretics). They should also take into account any use of PPIs obtained over-the-counter.

Patients have been warned not to use over-the-counter PPIs for more than 4 weeks. All PPI patients should seek medical care if they experience symptoms of hypomagnesaemia.

The MHRA also warned that two studies have suggested the risk of fracture is increased by 10–40% above baseline in people who take PPIs for extended periods of time. The primary studies in these analyses have varied in the extent to which they have adjusted for other potential risk factors for fracture, and use of calcium or vitamin D. Doctors have been advised to treat patients at risk of osteoporosis according to current clinical guidelines and ensure they have an adequate intake of vitamin D and calcium. They should also take into account any use of PPIs obtained over-the-counter.

PPI patients have been advised to consult their doctor to make sure they are taking enough vitamin D and calcium. Again, the MHRA warned against the use of over-the-counter PPIs for longer than 4 weeks.

Lawsuits Alleging Propecia Causes Permanent Sexual Side Effects Consolidated in New York Federal Court

Wed, 18 Apr 2012 00:00:00 -0700

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has ordered that all federally-filed Propecia (finasteride 1mg) lawsuits be transferred to U.S. District Court, Eastern District of New York, for coordinated pre-trial proceedings. The new Propecia multidistrict litigation will be presided over by U.S. District Judge John Gleeson.

So far, nine Propecial lawsuits pending in six federal districts are heading to the new multidistrict litigation, but it is anticipated that more will be filed.   All the actions involve allegations that use of Propecia causes persistent sexual dysfunction in a subset of men who took the drug, even after they discontinued its use. Sexual side effect that may result from Propecia use include:

•    erectile dysfunction
•    low libido
•    problems with orgasm
•    infertility
•    depression
•    suicide

According to the JPML's Transfer Order dated April 16, all parties, including Propecia maker Merck & Co., had supported the consolidation of the federal lawsuits. Plaintiffs had supported transfer to the Eastern District of New York. However, Merck had sought centralization of the complaints in the District of New Jersey, but had suggested the Eastern District of New York as an alternative.    The JPML determined that the Eastern District of New York is convenient and accessible forum for the Propecia litigation, pointing out that because Merck is headquartered in nearby Whitehouse Station, New Jersey, it is close to where relevant evidence and witnesses are likely located.

A multidistrict litigation allows lawsuits associated with a particular product to be coordinated under one judge for pretrial litigation to avoid duplicative discovery, inconsistent rulings and to conserve the resources of the parties, witnesses and the court. When lawsuits are consolidated as a multidistrict litigation, each retains its own identity. If the multidistrict litigation process does not resolve the cases, they are transferred back to the court where they originated for trial.

The announcement of the Propecia consolidation comes less than a week after the U.S. Food & Drug Administration (FDA) announced that new labels would be added to Propecia, as well as a 5mg version of finasteride, Proscar, regarding their association with persistent male sexual side effects. The Propecia label was updated to include information about libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug. Information regarding decreased libido that continued after discontinuation of the drug was added to the Proscar label. A revision to both the Propecia and Proscar labels will include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation, the FDA said.

Cancer Findings Raise More Medtronic Infuse Worries

Mon, 16 Apr 2012 00:00:00 -0700

A study presented this past November raised serious concerns about cancer risks that could be associated with Medtronic Inc.'s Infuse Bone Growth product.   The study was conducted by long-time Infuse critic, Dr. Eugene Carragee, and found that within a year of implantation, cancer risks more than doubled in Infuse patients. At three years after implantation, the increased cancer risk grew to nearly five-fold.

Carragee's cancer study, presented at the annual North American Spine Society meeting in Chicago, isn't the first time the Stanford University professor and Spine Journal editor has raised concerns about Infuse. This past summer, he edited an entire issue of The Spine Journal dedicated to rhBMP-2 products which raised serious questions about the validity of the research that was used to gain regulatory approval of Infuse. One of the articles included in the journal, co-authored by Carragee, found that Medtronic-paid surgeons had failed to report serious complications from Infuse, including:

•    Cancer
•    Sterility in men
•    Infections
•    Bone dissolution
•    Worsened back and leg pain

Carragee's cancer study pooled clinical trial data from Infuse, and a high-dose version of the same protein, called Amplify. Medtronic also developed Amplify, but failed to garner U.S. Food & Drug Administration (FDA) approval for the product because of concerns it could increase cancer risks.

According to a report from The New York Times, Carragee’s analysis of Medtronic trial results for Amplify showed a significantly higher number of cancers in the study group that received the product when compared to a control group that received a bone graft as part of a spinal fusion. At three years after surgery, there were 20 cancers in the Amplify group versus five cases in the bone graft group.

Carragee pointed out that the Amplify findings could be important for Infuse patients, many of whom received Infuse in off-label procedures. Doctors often administered Infuse off-label at levels significantly above the recommended dosages, ones that approach or exceed the amount of rhBMP-2 found in a dose of Amplify, he said.

It is estimated that roughly 85% of Infuse procedures involve off-label use.

One interesting note, during his presentation, Carragee pointed out that the industry-sponsored studies upon which his analysis was based neglected to discuss the association between rhBMP-2 and cancer.

Serious Brain Infection Reported In Gilenya Patient

Mon, 16 Apr 2012 00:00:00 -0700

We’ve been following serious side effects linked to patients taking multiple sclerosis (MS) medication Gilenya (gingolimod). Now, a serious brain infection has been reported in a Gilenya patient. Gilenya was approved for the treatment of relapsing-remitting MS and is used to reduce the frequency of flare-ups and delay physical disability.

The patient, who was taking the Novartis AG drug, developed a potentially deadly infection of the brain, said Bloomberg Businessweek. The patient also received a Tysabri injection, which is manufactured by Biogen Idec Inc. and Elan Corp., prior to taking Gilenya, according to an email Novartis sent Businessweek. Tysabri increases viral infections known as progressive multifocal leukoencephalopathy, which can lead to death or severe disability, according to a warning Tysabri’s label.

Although Novartis argued that Tysabri is the likely culprit, it said that “a contribution of Gilenya to the evolution of this case cannot be excluded.”

This is the first case of this type of infection in Gilenya users since it was approved in 2010; 36,000 patients have been treated with the drug since its approval. Meanwhile, we recently wrote that Gilenya is under review by regulators in the U.S. and Europe. According to Businessweek, the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA) are reviewing the deaths of 11 Gilenya patients, said Businessweek. The EMA is expected to release its results by April 20.

The FDA review was announced last December after a patient died within 24 hours of taking his/her first dose of Gilenya. EMA regulators started their review in February after receiving reports of 10 additional deaths among Gilenya patients. According to Novartis AG, six deaths were unexplained, three resulted from heart attacks, and one was due to disruption of heart rhythm.

Most recently, the Institute for Safe Medication Practices (ISMP) called for the FDA to restrict use of Gilenya and improve its patient monitoring following a review of adverse events reported to the FDA in the second quarter of last year. “Problems of widespread toxicity that were already evident in clinical testing of (Gilenya) are now producing strong signals in the post-market adverse event data,” ISMP.

Of 286 reports, 60 involved retinal injuries and other adverse vision effects; 68 involved infection reports at various areas of the body, eye, skin, urinary tract, and upper respiratory tracts; and a number of vascular-related adverse effects including 16 blackouts or syncope, 27 reductions in blood pressure, slow heart rate, or bradycardia, and 10 cases of peripheral edema, said Pharmalot.

ISMP, while acknowledging Gilenya’s advantages, noted that clinical testing conducted prior to FDA approval “revealed a troubling safety profile that might have halted the development of drugs for many other disorders with a less serious long-term prognosis,” said Pharmalot previously. ISMP also discussed a decision made by Novartis to discontinue a 1.25 mg dose over very serious adverse events, including two deaths from opportunistic herpes infections, a rare and fatal MS deterioration, and six vascular events: The clinical trial arm focused on the 1.25 mg dose was terminated for safety reasons; Novartis only sought approval of a 0.5 mg dose.

Meanwhile data provided to the FDA revealed a number of serious side effects—birth defects in typical animal screening studies; herpes infections; lower respiratory tract infections, as well as unusual ear, sinus, and eye infections; and two deaths—yet agreed to fast track Gilenya’s approval schedule

Of note, eight percent of patients prescribed the recommended dose of Gilenya tested with evidence of liver damage, although routine liver testing is not recommended. And, trials before approval included three cancer deaths in which the FDA was not able to rule out Gilenya as a potential culprit.

Proscar, Propecia Labels will Warn of Long-Lasting Sexual Side Effects

Fri, 13 Apr 2012 00:00:00 -0700

Men who use Propecia (finasteride 1 mg) and Proscar (finasteride 5mg) are being warned today that the drugs can cause a variety of male sexual side effects, including some that may persist after use of the drugs have been discontinued. According to the U.S. Food & Drug Administration (FDA), the labels for both Proscar and Propecia are being updated to include new warnings about these potentially long-lasting sexual side effects, including libido disorders, ejaculation disorders, and orgasm disorders.

According to the FDA, the label for Propecia will now warn that problems with libido, ejaculation and orgasm may continue after the drug is discontinued. A warning will be added to the Proscar label regarding decreased libido that may also persist once use of the drug is stopped. The labels for both medications will also be updated to include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation.

The FDA decided to update the Proscar and Propecia labels after 421 postmarketing reports of sexual dysfunction among Propecia users between 1998 and 2011, 59 of which reported that the side effects lasted for at least three months after they stopped taking the drug. The agency also said it reviewed 131 cases of erectile dysfunction and 68 cases of lowered libido reported by users of Proscar.

The FDA maintains that both Proscar and Propecia are still safe drugs, asserting that only a small number of men who use the medications will experience sexual side effects.

Both Proscar and Propecia are marketed by Merck & Co. Propecia is approved to treat male pattern baldness, while Proscar is prescribed to men with enlarged prostate.

Report Claims 500 Yaz, Yasmin Blood Clot Lawsuits Settled by Bayer

Fri, 13 Apr 2012 00:00:00 -0700

Just days after the U.S. Food & Drug Administration (FDA) ordered new information about increased blood clot risks associated with Yaz, Yasmin and other drospirenone-containing birth control pills, it's been learned that Bayer AG has settled some 500 Yaz and Yasmin lawsuits alleging the drugs caused serious, sometimes fatal clots that can lead to heart attacks and strokes. According to Bloomberg News, the Yaz and Yasmin lawsuit settlements have not been publically announced, but were confirmed by two anonymous sources close to the litigation.

Bayer Healthcare, the Germany-based company's U.S. division, would not comment on a specific number of settlements, or their amount, but did confirm in an email to Bloomberg that "some cases pending in the current YAZ/Yasmin litigation in the U.S. are being settled."

In February, Bayer revealed in its Annual Report that it had settled somewhere in the neighborhood of 70 Yaz and Yasmin side effect lawsuits. Bayer did not reveal the terms of the settlements, nor did it admit any fault.

Earlier this week, the FDA had announced that the labels for Yaz, Yasmin and similar birth control pills would be updated to include additional information regarding blood clots, after its review of observational studies indicated that oral contraceptives made with drospirenone might pose a higher risk of blood clots compared to those made with other forms of progestin.

Currently, thousands of lawsuits are pending against Bayer in a multidistrict litigation under way in Illinois federal court alleging that Yaz and Yasmin caused serious side effect injuries, including blood clots. Late last year, the first trials in that litigation, which were scheduled to start in January, were postponed, and the cases were ordered to mediation. According to Bloomberg, the mediation was ordered at the request of Bayer, and today's news indicates that the move might be paying off for the company. One expert interviewed by Bloomberg said the company likely wants to avoid the risks and costs of litigation in U.S. courts. Mediation is generally a less expensive route than litigation.

FDA Says Yaz, Yasmin May Up Blood Clot Risks, Orders Label Changes for Drospirenone Birth Control Pills

Wed, 11 Apr 2012 00:00:00 -0700

The U.S. Food & Drug Administration (FDA) announced yesterday that it has finished reviewing a number of studies examining the link between Yaz, Yasmin and similar birth control pills and blood clots. According to the agency, its review indicated that drospirenone-containing birth control pills like Yaz and Yasmin may pose a higher risk of blood clots compared to oral contraceptives made with other birth control pills. In a Drug Safety Communication issued late yesterday, the FDA said the label of Yaz, Yasmin and similar birth control pills would be updated to include information about the studies it reviewed.

Background

Yaz, Yasmin and similar birth control pills are made with drospirenone, a fourth generation synthetic form of the female hormone, progestin. This form of progestin can elevate the body’s potassium levels and lead to a condition called hyperkalemia in certain patients. Hyperkalemia can cause a number of complications, including heart arrhythmias and cardiac arrest.
A number of studies have found that birth control pills that contain drospirenone may be more likely to cause blood clots compared to oral contraceptives made with other progestins. Side effects possibly associated with Yaz, Yasmin and similar contraceptives include:

Blood clots
Deep vein thrombosis
Pulmonary Embolism
Heart attack
Stroke
Sudden death

The FDA issued previous Drug Safety Communications related to the risk of blood clots with birth control pills that contain drospirenone on May 31, 20118, September 26, 20119, and October 27, 201110. In December 2011, a panel of FDA advisors voted 21-5 to recommend that labels for Yaz, Yasmin and similar pills be updated with stronger warnings about their possible potential to cause serious, life threatening blood clots.

What did the FDA's Yaz and Yasmin Safety Review Entail?

The FDA reviewed a number of observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Some of the studies indicated an increased risk of blood clots with Yaz, Yasmin and similar birth control pills, while others did not. According to the FDA, the studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not. The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots. For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills, the FDA said.

The research reviewed by the FDA included an agency-study released in October 2011 that found drospirenone-containing oral contraceptives increased the risk of blood clots by almost 74%, compared to other oral contraceptives that are made with an older form of progestin.

What Action is the FDA Taking?

According to the FDA, the new labels for Yaz and Yasmin will now included the following information:

That some epidemiological (observational) studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products
A summary of the previously released results of an FDA-funded study of the blood clot risk. That study, released last fall, found that drospirenone-containing birth control pills were associated with a 1.5-fold increase in the risk of blood clots, compared to those made with other progestins

Yaz and Yasmin will be subject to the modified labels, as will:

•    Beyaz (drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg)
•    Drospirenone and Ethinyl Estradiol (drospirenone 3 mg and ethinyl estradiol 0.03 mg)
•    Drospirenone and Ethinyl Estradiol (drospirenone 3 mg and ethinyl estradiol 0.02 mg)
•    Gianvi (drospirenone 3 mg and ethinyl estradiol 0.02 mg)
•    Loryna (drospirenone 3 mg and ethinyl estradiol 0.02 mg)
•    Ocella (drospirenone 3 mg and ethinyl estradiol 0.02 mg)
•    Safyral (drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg)
•    Syeda (drospirenone 3 mg and ethinyl estradiol 0.03 mg)
•    Zarah (drospirenone 3 mg and ethinyl estradiol 0.03 mg)

Yaz and Yasmin Lawsuits
Yaz, Yasmin and similar birth control pills have been named in thousands of lawsuits alleging they caused users to suffer serious, life-threatening side effects including blood clots, strokes and gallbladder problems. Most of the cases have been consolidated in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) currently pending before Judge David Herndon in the U.S. District Court for the Southern District of Illinois

ISMP Details More Pradaxa Bleeding Reports to FDA

Mon, 09 Apr 2012 00:00:00 -0700

More bad news this week for Pradaxa. According to the latest QuarterWatch report from the Institute for Safe Medicine Practices (ISMP), Pradaxa was associated with a total 856 reports of serious, disabling or fatal injury in the second quarter of 2011. Of those, 117 involved deaths that could be associated with serious Pradaxa bleeding.

Since late last year, concerns about Pradaxa’s heart and bleeding side effects have grown, leading some to question whether its risks outweigh its benefits. The Food and Drug Administration (FDA) announced in December that it was conducting a review of Pradaxa safety data after receiving enough reports of brain hemorrhaging and severe gastrointestinal bleeding among patients taking the drug. In November, the maker of Pradaxa said it had received 260 reports of fatal bleeding among Pradaxa patients.

According to the ISMP, most of the serious cases of Pradaxa bleeding submitted to the FDA's Adverse Event Reporting System occurred in people older than 80.

Bleeding is a common side effect of all blood thinners, including warfarin. However, warfarin bleeding can be stopped with the administration of vitamin K, but there is no similar antidote for Pradaxa bleeding.

In March, bleeding risks associate with Pradaxa were highlighted by an article published in the Journal of Neurosurgery that detailed the death of an 83-year-old Pradaxa patient from a brain bleed that followed a minor fall. Many of the patients who take Pradaxa are elderly, and such falls are common with this population.

Group Calls for Significant Gilenya Restrictions

Fri, 06 Apr 2012 00:00:00 -0700

A patient safety group believes access to the multiple sclerosis drug Gilenya should be severely restricted because its short time on the market has been plagued by reports of fatal adverse reactions.

According to a report at Pharmalot.com, the Institute for Safe Medicine Practices’ call for the Food and Drug Administration to limit the use of Gilenya is based mostly on its association with more than a dozen deaths and an overwhelming number of adverse reaction reports during its first few months on the worldwide market.

Gilenya was approved last year as a new treatment for multiple sclerosis (MS). It is the first pill-form drug used in the treatment of the debilitating and often fatal disease.

During the second quarter, the Food and Drug Administration received 286 adverse reaction reports from Gilenya patients, including 60 cases of “retinal injuries” and other eye conditions. The drug was also associated with at least 68 cases of severe infections, especially of the eyes, skin, urinary tract, and upper respiratory tract. Cases of blackouts, reduced blood pressure, bradycardia (slow heart rate), and peripheral edema were also common among those adverse reaction reports.

In addition to those reports, the FDA is also investigating the death of a patient taking Gilenya after its maker, Novartis, announced it was looking into that report. Shortly after that announcement last year, the European Medicines Agency said it had received another 11 reports of deaths possibly attributed to an MS patient taking Gilenya.

The watchdog group fears Gilenya will always pose these risks to MS patients and that only close monitoring of a select group of patients will help reduce the frequency of these adverse reaction reports. ISMP said the drug demonstrated an association to these similar side effects during pre-market clinical trials but was likely approved by the FDA because it was a first-of-its-kind treatment.

Further adding to the group’s worries is the move by Novartis shortly after it was on the market to stop selling the highest dose, 1.25 mg, of Gilenya because the drug at that strength had been linked to an “opportunistic” herpes infection, a life-threatening “MS deterioration” and other maladies.

The group is concerned with the rush to get Gilenya approved, noting that it was rushed through the agency’s fast-track approval system despite the pre-market testing showing it could cause widespread problems for patients.

A senior scientist with ISMP told the news source for the report, “The unfolding safety profile of Gilenya shows that getting faster access to innovative new drugs can also involve substantial risks to the public. The fact is a powerful new drug might help you and it might harm you, and only time-consuming testing separates the help from the harm.”

Breast Cancer Risk May Rise with Recent Depo-Provera Use

Thu, 05 Apr 2012 00:00:00 -0700

Depo-Provera (depo-medroxyprogesterone acetate, or DMPA) an injectable contraceptive used by about 1.2 million U.S. women, may increase the risk of invasive breast cancer in young women. Depo-Provera is a progestin-only birth control method, and is made with the same type of progestin found in Prempro, a hormone replacement therapy medication that has been associated with breast cancer in post-menopausal women.

Few studies have been done to assess the potential of Depo-Provera to cause breast cancer in young women. However, some international studies have produced mixed findings. To add to knowledge about this possible risk, researchers at the Fred Hutchinson Cancer Center compared data on 1,028 Seattle-area women ages 20 to 44 who had been diagnosed with breast cancer to 919 age-matched controls who did not have a history of breast cancer. About 10 percent of subjects in the study reported using Depo-Provera.

Recent use of Depo-Provera (within five years) for 12 months or longer was associated with a 2.2-fold increased risk of invasive breast cancer, the study found. Women who used DMPA for less than a year or who had stopped using it more than a year earlier did not have an increased risk of breast cancer. The risk began to lessen in the months after a woman stopped using Depo-Provera.

“While DMPA is widely used by women throughout the world, there are limited data on the association between DMPA and breast cancer incidence,” Christopher I. Li, M.D., PhD., a member of the Hutchinson Center’s Public Health Sciences Division, said in a press release. “Our study adds to the body of knowledge from international studies conducted in a diverse group of countries – Kenya, New Zealand, Thailand, Mexico and Costa Rica – which have shown that one of the risks associated with DMPA use may be an increased risk of breast cancer."

Long-Term Bisphosphonate Side Effects May Include Esophageal Cancer

Tue, 03 Apr 2012 00:00:00 -0700

Evidence continues to mount that long-term use of oral bisphosphonates, including Fosamax, could lead to serious consequences continues to mount. One of those possible consequences could be the development of esophageal cancer.

According to the U.S. Food & Drug Administration (FDA), approximately 5 million Americans use oral bisphosphonates like Fosamax. They are mostly used for the treatment and prevention of osteoporosis in post-menopausal women. Other approved indications include treatment to increase bone mass in men with osteoporosis, treatment and/or prevention of glucocorticoid-induced osteoporosis, and Paget’s disease.

Case reports have suggested an association between use of oral bisphosphonates for osteoporosis and increased risk of esophageal cancer, but definitive proof is lacking. It had long been assumed that Fosamax and other bisphosphonates could safely be taken indefinitely, but as side effects have mounted, that assumption has been challenged. Unfortunately, most studies of bisphosphonates have only looked at the drugs for a few years.

In 2010, the FDA added information to the Warnings and Precautions section of the drugs' labels describing the risk of atypical thigh fractures. As we reported previously, there have been hundreds of reports of atypical thigh fractures occurring in patients taking bisphosphonates, often for longer than five years.

In September 2010, a study published in the British Medical Journal found that people who had taken the oral bisphosphonates over five years had twice the risk of developing esophageal cancer. The study analyzed data from the UK General Practice Research Database, which has anonymised patient records for around six million people. The researchers focused on men and women 40 years old, 2,954 of whom had esophageal cancer. Another 2,018 had stomach cancer, while 10,641 had colorectal (bowel) cancer. All of the subjects were diagnosed between 1995 and 2005. The study found that those with 10 or more prescriptions for oral bisphosphonates, or with prescriptions over about five years, had nearly double the risk of esophageal cancer compared with people with no bisphosphonate prescriptions. No increase risk was seen with colorectal or stomach cancer.

The FDA is currently conducting an on-going review of the possible link between oral bisphosphonates and esophageal cancer. In a Drug Safety Communication issued in September 2010, the agency noted that studies on possible link have been conflicting, and it has been unable to reach a conclusion thus far. While the FDA said it believed the benefits of bisphosphonates continued to outweigh their risks, it acknowledged that further study of the issue was needed.

Medtronic, Investors Agree to Settle Infuse Class Action Lawsuit for $85 Million

Mon, 02 Apr 2012 00:00:00 -0700

Without admitting any wrongdoing, Medtronic Inc. has agreed to settle a shareholder lawsuit alleging the company made false and misleading statements about its Infuse Bone Graft product. According to a report from Bloomberg News, Medtronic will pay $85 million to settle the Infuse Class Action lawsuit, which was filed in 2008 in Minneapolis federal court by institutional investors, including the Minneapolis Firefighters Relief Association, the Oklahoma Teachers' Retirement System, the Oklahoma Firefighters Pension Fund and the Westmoreland County Employee Retirement System.

The suit alleged that, between November 2006 and November 2008, the company misled investors about the profitability of Infuse. The complaint further alleged that the company had deliberately promoted the Infuse system for off-label uses and failed to disclose that its sales were largely dependent on unapproved uses. According to the complaint, Medtronic stock plunged 13 percent after it was forced to reveal that the Justice Department was investigating the alleged off-label promotion of Infuse.

The settlement, which is still subject to court approval, doesn't end the legal troubles Medtronic faces over Infuse. The company was just named in a separate shareholder lawsuit earlier this month that made similar claims about Infuse. The company has also been named in Infuse personal injury lawsuits by people who allegedly suffered debilitating injuries when Infuse was used off-label.

Over the summer, The Spine Journal raised serious questions about the validity of the research that was used to gain regulatory approval of Infuse. Medtronic Infuse injuries can include ectopic or uncontrolled bone growth at or near the site of the surgery; ongoing or chronic radiating pain in the legs or arms; male sterility, retrograde ejaculation, or other uro-genital injuries; nerve injuries causing severe and chronic pain; and even cancer. In cervical spine surgeries some Infuse patients have experienced acute severe neck swelling several days after surgery resulting in death or permanent injury.

In November, a prominent researcher warned that Infuse may be associated with a higher risk of developing cancer. In December, Medtronic settled a U.S. Department of Justice lawsuit over Infuse marketing for $23.5 million without admitting wrongdoing,

As we've reported previously, it's thought that roughly 85% of the producers that have involved Infuse are off-label uses. In July 2008, the U.S. Food & Drug Administration (FDA) warned that Infuse and similar bone growth products had caused serious, sometimes life threatening complications, when used in off-label in spinal procedures. The FDA approved Infuse, which is made with a genetically engineered material called rhBMP-2 (recombinant human Bone Morphogenetic Protein-2), 2002 for use in one type of spine surgery called anterior approach lumbar fusion, and two types of dental surgeries.

First Time Bisphosphonate Users at Risk for Eye Disorders

Mon, 02 Apr 2012 00:00:00 -0700

Two serious eye disorders - anterior uveitis and scleritis - could be potential side effects for new users of Fosamax and other oral bisphosphonates, according to study published in the Journal of the Canadian Medical Association. According to the study's findings, one excess case of uveitis could be expected to occur for every 1,100 new bisphosphonate prescriptions, and one additional case of scleritis for every 370 new users.

Researchers from the Child and Family Research Institute and the University of British Columbia, Vancouver, BC, undertook a study to examine and quantify the risk associated with uveitis or scleritis and oral bisphosphonates because the literature is limited, though cases have been reported among users of the drugs. They included 934,147 people in British Columbia who had visited an ophthalmologist between 2000 and 2007. Of the total, 10,827 were first-time users of bisphosphonates and 923,320 were nonusers.

The researchers found that the incidence rate for uveitis in first-time users was 29/10 000 person-years and 63/10 000 person-years for scleritis compared with 20/10 000 person-years for uveitis and 63/10 000 for scleritis in nonusers

"The risk of inflammatory ocular adverse events, including scleritis and uveitis, is not highlighted in most package inserts included with oral bisphosphonates," the authors conclude. "Our study highlights the need for clinicians to inform their patients about the signs and symptoms of scleritis and uveitis, so that prompt treatment may be sought and further complications averted."

Symptoms of uvietis include eye redness, eye pain, light sensitivity, blurred vision, dark floating spots in the field of vision, decreased vision, and a whitish area (hypopyon) inside the lower part of the colored area of the eye (iris). Symptoms of scleritis include blurred vision, severe eye pain, red patches on the normally white part of the eye, painful sensitivity to light, and tearing of the eye.

Case Study Points to Pradaxa Traumatic Bleeding Dangers

Fri, 30 Mar 2012 00:00:00 -0700

A case study published earlier this in the Journal of Neurosurgery highlighted the risk elderly Pradaxa patients could face from only a minor trauma. The report detailed the death of an 83-year-old Pradaxa patient from a traumatic brain bleed that followed a minor fall.

The report is disturbing because many of the people taking Pradaxa are elderly. And this population often experiences balance problems and other disorders that make them susceptible to falls and minor traumas. Many older people also suffer from kidney problems, and need more time to eliminate Pradaxa from their system.

This is especially problematic because there is no antidote available to put an end to Pradaxa bleeding. Dialysis with IV fluids can counter the effects of Pradaxa but patients with atrial fibrillation also face a risk impaired heart function if they are presented with a rush of fluids.

When the patient in the case study was admitted to the hospital, he was alert and responsive and a CT scan revealed only minor internal brain bleeding. After just two hours however, the bleeding had spread to an entire hemisphere in his brain. Dialysis in patients who’ve suffered mild brain trauma could help to remove most of the drug from the system but the decision to attempt this treatment in this case was done too late and by that time, the patient had lost too much blood.

The Food and Drug Administration is currently conducting a review of Pradaxa safety data after receiving enough reports of brain hemorrhaging and severe gastrointestinal bleeding among patients taking the drug. In November, the maker of Pradaxa said it had received 260 reports of fatal bleeding among Pradaxa patients.

Celexa Heart Rhythm Dosage Warnings Updated

Thu, 29 Mar 2012 00:00:00 -0700

The label for Celexa (citalopram), a selective serotonin reuptake inhbitor antidepressant, has been revised to clarify warnings about its association with abnormal heart rhythms. According to the U.S. Food & Drug Administration (FDA), Celexa should no longer be used at doses greater than 40 mg per day because it could cause potentially dangerous abnormalities in the electrical activity of the heart.

Changes in the electrical activity of the heart (specifically, prolongation of the QT interval of the electrocardiogram [ECG]) can lead to a risk of an abnormal heart rhythm called Torsade de Pointes, which can be fatal, according to the FDA. Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to having low levels of potassium and magnesium in the blood.

Use of Celexa is being discouraged in people with certain conditions, including congenital long QT syndrome, bradycardia, hypokalemia, or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure. Use of Celexa is also not recommended for patients who are taking other drugs that prolong the QT interval. According to the FDA, the maximum recommended dose of citalopram is 20 mg per day for patients with hepatic impairment, patients who are older than 60 years of age, patients who are CYP 2C19 poor metabolizers, or patients who are taking concomitant cimetidine (Tagamet) or another CYP2C19 inhibitor, because these factors lead to increased blood levels of citalopram, increasing the risk of QT interval prolongation and Torsade de Pointes.

In 2011, a total of approximately 31.5 million prescriptions were dispensed for Celexa and generics from U.S. outpatient retail pharmacies. That same year approximately 7.2 million patients received a dispensed prescription for citalopram from U.S.

Pradaxa Heart, Bleeding Side Effects Raising Concerns

Wed, 28 Mar 2012 00:00:00 -0700

Since late last year, concerns about Pradaxa’s heart and bleeding side effects have grown, leading some to question whether its risks outweigh its benefits. Pradaxa was approved by the U.S. Food & Drug Administration (FDA) in 2010, and was expected to replace warfarin, a decades-old anti-clotting drug.

"What we've seen is that the amount of people having death from hemorrhagic events in the brain is higher than expected," epidemiologist Adrian Hernandez recently told the Cleveland Plain Dealer. "That's another part that's being played out now as part of this risk-benefit."

According to the Plain Dealer, Hernandez worked on a study published in the Archives of Internal Medicine in January, which pooled data from six smaller Pradaxa trials. The study found that patients in the Pradaxa groups had a 33 percent increased chance of having a heart attack. Overall, there were there were 237 coronary events among the 20,000 combined trial participants taking Pradaxa compared with 83 of 10,514 taking warfarin, the Plain Dealer said.

Earlier this month, bleeding risks associate with Pradaxa were highlighted by an article published in the Journal of Neurosurgery that detailed the death of an 83-year-old Pradaxa patient from a brain bleed that followed a minor fall. Many of the patients who take Pradaxa are elderly, and such falls are common with this population.

Last year, Boehringer Ingelheim acknowledged that since March 2008, it had received 260 reports of bleeding-related deaths in patients taking Pradaxa. The FDA launched a review of Pradaxa in December over reports of bleeding-related side effects. Regulators in Europe and Japan have also directed Boehringer Ingelheim to strengthen warnings for the Pradaxa.

Bleeding is a common side effect of all blood thinners, including warfarin. However, warfarin bleeding can be stopped with the administration of vitamin K, but there is no similar antidote for Pradaxa bleeding.

Actos Whistleblower Also Claims Takeda Improperly Reported Bladder Cancer Cases to FDA

Tue, 27 Mar 2012 00:00:00 -0700

The same whistleblower who has accused Takeda Pharmaceuticals of obscuring the seriousness of heart failure reports linked to Actos has also alleged that the company handled Actos bladder cancer reports the same way. Dr. Helen Ge, a former medical reviewer for the company, made the allegations in an Actos whistleblower lawsuit unsealed last month in Massachusetts federal court.

According to Ge's complaint, Takeda’s adverse event database for Actos held more than 100 bladder cancers reported to the company, but only 72 were reported to the Food & Drug Administration, which Dr. Ge referred to as “a serious discrepancy.” Ge also alleges that at least 40 people enrolled in a study at Yale University were diagnosed with bladder cancer while taking Actos. Though Yale reported all of the cases as "related to" Actos, Ge claims that when she attempted to report them to the FDA database, she was directed to change her assessment by her superiors and Takeda-Japan.

Ge also that the company did not properly classify cases of congestive heart failure associated with the type 2 diabetes drug when they were reported to the FDA Adverse Event Reporting System. Ge claims Takeda was trying to make Actos appear safer than Avandia.

Pharmaceutical companies are required to report drug side effects to the FDA. But according to Ge, Takeda directed its medical reviewers to "change their professional opinion regarding the classification of Actos adverse events” on multiple occasions between 2007 and 2010. Ge also claims that when she protested, her contract with Takeda was terminated.

5-ARIs Get New Warnings for High-Grade Prostate Cancer in Canada

Wed, 21 Mar 2012 00:00:00 -0700

Health Canada has announced new warnings for 5-alpha reductase inhibitors, or 5-ARIs, regarding there association with an aggressive form of prostate cancer. The new warnings will apply to Proscar (finasteride 5mg), Propecia (finasteride 1mg), Avodart (dutasteride) and Jalyn (dutasteride and tamsulosin). Proscar, Avodart and Jalyn are all used to treat enlarged prostate, while Propecia is used to treat male pattern hair loss.

According to Health Canada, the new safety information is based on Health Canada's review of two large international clinical trials, the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. The trials showed that the long-term daily use (over 4 years) of finasteride (5 mg) and dutasteride in men aged 50 years and older was associated with a small but statistically significant increased risk of high-grade prostate cancer. The 1 mg finasteride strength (Propecia) was not included in these trials but a potential risk has not been ruled out, according to Health Canada.

High-grade prostate cancer is an aggressive type of prostate cancer that grows and spreads more quickly than low-grade prostate cancer. Last summer, the U.S. Food & Drug Administration (FDA) issued a Drug Safety Communication notifying the public that the “Warnings and Precautions” sections of the labels of all FDA-approved 5-ARIs was being modified to include new information that they may increase the risk of high-grade prostate cancer. The FDA communication was prompted by its review of the same studies cited in the Health Canada announcement.

Bleeding Reports Prompt Pradaxa Label Changes in Canada

Wed, 21 Mar 2012 00:00:00 -0700

Reports of Pradaxa bleeding side effects have prompted regulators in Canada - where it is sold as Pradax - to add new warnings to its label regarding use of the drug in kidney patients. New information will also be added to address use of Pradaxa in patients with severe valvular disease or prosthetic heart valves.

According to a notice from Health Canada, the Pradax patient monograph will now include new recommendations to assess renal function in patients being considered for, or already being treated with Pradax.

The Health Canada notice also pointed out that the safety and efficacy of Pradax have not been studied in patients with hemodynamically significant rheumatic valvular heart disease, especially mitral stenosis, or patients with prosthetic heart valves. There is also no data to support that Pradax provides adequate anticoagulation in patients with prosthetic heart valves, with or without atrial fibrillation. Therefore, the use of Pradax is not recommended in patients with hemodynamically significant rheumatic valvular heart disease or in patients with prosthetic heart valves, the agency said.

Finally, Health Canada reminded that Pradax is contraindicated in patients with severe kidney impairment, and should not be used in patients who are at risk for bleeding. Pradax patients should be watched for signs of bleeding or anemia. Treatment with Pradax should be discontinued should severe bleeding occur and the source of bleeding investigate, Health Canada said.

According to Health Canada, the Pradaxa label changes were ordered due to post-marketing reports of serious bleeding among elderly and patients at high risk of bleeding or patients with renal impairment being treated with the drug. As we've reported in the past, Pradaxa bleeding has no antidote. Late last year, the maker of the drug confirmed that it had received 260 reports of bleeding-related deaths in patients taking Pradaxa since March 2008.

Off-Label Medtronic Infuse Procedure Left Teacher Permanently Disabled

Mon, 19 Mar 2012 00:00:00 -0700

Some patients who have received Medtronic Inc.'s Infuse bone graft product have suffered serious, life-threatening complications following off-label use of the bone growth protein. Side effects linked to off-label use of Infuse include incapacitating swelling in the throat that has caused permanent injury in some patients.

That's what apparently happened to Laurie DeNeui, a 46-year-old ex-teacher from North Dakota. DeNeui underwent a neck surgery in 2005 to treat whiplash-related headaches. During that surgery, her doctor implanted Infuse into her neck, a use that has not been approved by the U.S. Food & Drug Administration (FDA). She alleges that she was not made aware that Infuse hadn't been approved for that type of surgery, and would not have undergone the procedure had she been.

According to an article recently published in the Minneapolis Star-Tribune, DeNeui now has difficulty speaking, swallowing and breathing, a feeling she likens to having "a jawbreaker in my throat. No doctor has been able to help her, and it's unlikely DeNeui will be able to teach again, thanks to her disability.

The FDA approved Infuse, which is made with a genetically engineered material called rhBMP-2 (recombinant human Bone Morphogenetic Protein-2), 2002 for use in one type of spine surgery called anterior approach lumbar fusion, and two types of dental surgeries. However, it's thought that roughly 85% of the producers that have involved Infuse are off-label uses. In July 2008, the FDA warned that Infuse and similar bone growth products had caused serious, sometimes life threatening complications, when used in off-label in spinal procedures.

Since 2008, Medtronic has been named in investigations being conducted by a U.S. Senate Committee, the U.S. Justice Department, and the state of California. At issue is whether or not Medtronic illegal promoted Infuse for use in procedures for which it was never approved. While doctors are free to use approved medical devices in anyway they see fit, it is illegal for device makers to promote those uses.

Medtronic Infuse Woes Spawn Another Shareholder Lawsuit

Fri, 16 Mar 2012 00:00:00 -0700

Medtronic was hit this week with another shareholder lawsuit alleging the company illegally promoted off-label use of its Infuse bone growth product. This lawsuit alleges that because of false statements Medtronic and its officers made regarding Infuse, the company's stock price was artificially inflated. As a result, Medtronic was forced to repurchase more than $2.8 billion of its own shares at inflated rates, the lawsuit claims.

"Unbeknownst to shareholders, the company was risking adverse regulatory actions, investigations, lawsuits, and declining sales," the complaint states. "The improper statements and omissions have devastated Medtronic's credibility.

"Under the board's authorization, the company bought back more than $2,847,113,040 worth of its shares at a weighted average price of $50.39," the lawsuit alleges. "Tellingly, this weighted average price is substantially higher than Medtronic's share price of $31.60 on November 18, 2008, when its true business health was revealed."

Medtronic is facing a mountain of legal trouble over Infuse, including several product liability lawsuits claiming it caused serious complications in patients. Over the summer, The Spine Journal raised serious questions about the validity of the research that was used to gain regulatory approval of Infuse. Medtronic Infuse injuries can include ectopic or uncontrolled bone growth at or near the site of the surgery; ongoing or chronic radiating pain in the legs or arms; male sterility, retrograde ejaculation, or other uro-genital injuries; nerve injuries causing severe and chronic pain; and even cancer. In cervical spine surgeries some Infuse patients have experienced acute severe neck swelling several days after surgery resulting in death or permanent injury.

In November, a prominent researcher warned that Infuse may be associated with a higher risk of developing cancer. In December, Medtronic settled a U.S. Department of Justice lawsuit over Infuse marketing for $23.5 million without admitting wrongdoing,

In August 2009, the Minneapolis Firefighters’ Relief Association and other institutional investors alleged in a separate shareholder complaint that Medtronic had deliberately promoted the Infuse system for off-label uses and failed to disclose that its sales were largely dependent on unapproved uses. The lawsuit sought class action status on behalf of holders of the company's stock who purchased or acquired their shares between November 2006 and November 2008 and suffered financial losses. That lawsuit alleged Medtronic stock plunged 13 percent after it was forced to reveal that the U.S. Department of Justice was investigating the alleged off-label promotion of Infuse.

Parker Waichman Files 3 Dozen Fosamax Lawsuits on Single Day

Thu, 15 Mar 2012 00:00:00 -0700

Parker Waichman LLP has filed three dozen lawsuits on behalf of women who allegedly suffered Fosamax femur fractures after using the bisphosphonate for several years. All 36 of the Fosamax femur fracture lawsuits were filed by Parker Waichman LLP on March 5, in the Superior Court of New Jersey, Law Division, Atlantic County, where lawsuits involving alleged Fosamax side effects have been designated a mass tort (In re: Fosamax Litigation (No. 282 NJ. Super. Ct.)

All of the complaints name Merck Sharp & Dohme Corp. f/k/a Merck & Co., Watson Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. as Defendants. The lawsuits allege that as a direct and proximate result of their long-term use of Fosamax, the Plaintiffs suffered severe mental and physical pain and suffering, and have and will continue to sustain permanent injuries and emotional distress, along with economic losses resulting from medical expenses and living-related expenses related to their new lifestyle. All of the claims seek compensatory, punitive and treble damages, as well as ascertainable economic losses, reimbursement of the cost of Fosamax, reimbursement for all past, present and future health and medical costs related to Fosamax per quod, and derivative damages on behalf of the plaintiffs.

Fosamax and other bisphosphonates are used to treat osteoporosis in post-menopausal women and other bone disorders, including Paget's disease. In October 2010, the U.S. Food & Drug Administration asked the manufacturers of bisphosphonates used to treat osteoporosis, including Fosamax, to add information to the "Warnings and Precautions" section of the drugs’ labels describing the risk of atypical thigh fractures after a study linked long-term use of such drugs to this side effect.

According to Parker Waichman attorney Matthew McCauley, these three dozen Fosamax lawsuits are unlikely to be the last filed by the firm.

"Parker Waichman LLP is hearing from women on an almost daily basis who sustained life-changing injuries similar to those suffered by our plaintiffs after using Fosamax for years,” he said.

As the leading attorney in the Bisphosphonate Litigation Group at Parker Waichman LLP, McCauley is currently investigating bisphosphonate related femur fracture.

Parker Waichman Managing Partner Appointed to Actos Bladder Cancer Lawsuit Committee

Wed, 14 Mar 2012 00:00:00 -0700

Jerrold Parker, Managing Partner with Parker Waichman LLP, has been appointed to the Plaintiffs' Steering Committee in the growing Actos bladder cancer lawsuit multidistrict litigation, Re: Actos Products Liability Litigation, 11-2299, U.S. District Court, Western District of Louisiana (Lafayette). U.S. District Judge Rebecca Doherty, who is overseeing the Actos litigation, also appointed plaintiffs’ co-lead counsels, liaison counsel, and named members of the Plaintiffs' Executive Committee, according to a notice published on the Court's website.

The first hearing on the cases is set for March 22. According to the Court's notice, Judge Doherty decided to name plaintiff leadership roles ahead of that hearing so the committees could have their initial planning sessions with the Court on March 23rd, while the attorneys are still in Lafayette.

Takeda Pharmaceuticals and other defendants involved in the litigation are accused of concealing knowledge of Actos' bladder cancer risks and failing to adequately warn consumer and health care providers about its association with bladder cancer. According to a report from Bloomberg News, some legal experts believe Takeda could eventually face as many as 10,000 Actos bladder cancer lawsuits.

In June 2011, the U.S. Food & Drug Administration (FDA) issued a safety communication stating that use of Actos for more than one year may be associated with an increased risk of bladder cancer. Regulators in France and Germany also suspended sales of the drug their after a separate study commissioned by French regulators demonstrated an increased risk of bladder cancer associated with Actos in people who took it the longest and at the highest cumulative dose.

In December, the U.S. Judicial Panel on Multidistrict Litigation ordered that all Actos side effect lawsuits be consolidated in a multidistrict litigation before Judge Doherty. A multidistrict litigation allows lawsuits associated with a particular product to be coordinated under one judge for pretrial litigation to avoid duplicative discovery, inconsistent rulings and to conserve the resources of the parties, witnesses and the court. When lawsuits are consolidated as a multidistrict litigation, each retains its own identity. If the multidistrict litigation process does not resolve the cases, they are transferred back to the court where they originated for trial.

70 Yaz Side Effects Lawsuits Settled as of February, Bayer Says

Mon, 12 Mar 2012 00:00:00 -0700

The first Yaz side effects lawsuits have reportedly been settled. According to Bayer's latest annual report, the company had resolved 70 lawsuits alleging the Yaz birth control pill caused blood clots, heart attacks, strokes and other serious side effects as of February 13, 2012.

According to the "Legal Risk" section of the annual report, more than 11,300 lawsuits have been filed over its popular Yaz and Yasmin contraceptives, as well as generic versions of the drugs, Ocella and Gianvi. Bayer also stated that it expected more Yaz and Yasmin lawsuit filings in the future.

Bayer did not disclose the terms of its Yaz lawsuit settlements, but said it did not admit to any fault.

In December, a panel of advisors for the U.S. Food & Drug Administration (FDA) recommended stronger label warnings for Yaz, Yasmin and similar oral contraceptives regarding their possible association with blood clots. The outside advisors voted 21-5 that current label warnings for Yaz, Yasmin and other pills made with the progestin, drospirenone, are inadequate and need to include clearer information about data that have linked the pills to a higher risk of blood clot. The vote followed the release of several large studies that pointed to a higher risk of blood clots with pills like Yaz and Yasmin, compared to those made with an older form of progestin.

Most of the Yaz and Yasmin lawsuits filed against Bayer are pending before Judge David Herndon in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) in the U.S. District Court for the Southern District of Illinois. The lawsuits claim Yaz, Yasmin and similar drugs caused young women to suffer dangerous blood clots, heart attacks, strokes, pulmonary emboli, gall bladder disease and other serious side effects.

Late last year, Judge Herndon appointed a special master in the litigation, ordered both sides to meet with a mediator to discuss possible settlement of Yaz and Yasmin lawsuits. Judge Herndon also indefinitely postponed the bellwether, or test, trials that were supposed to have started in January in that litigation.

U.K. Regulator Issues Aliskiren (Rasilez and Tekturna) Update

Fri, 09 Mar 2012 00:00:00 -0800

U.K.'s health regulator has issued a Drug Safety Update detailing new contraindications for diabetics and kidney patients using the blood pressure drug, aliskiren (marketed as Rasilez and Tekturna). According to the Medicine and Healthcare Products Regulatory Agency (MHRA), the use of aliskiren in combination ACE inhibitors and Angiotensin II receptor blockers (ARB) is now contraindicated in these patients.

The MHRA also stated that the combination of aliskiren with an ACE inhibitor or ARB is not recommended in any other patients. Any use of aliskiren (either as monotherapy or in combination with other medicines) is no longer recommended in any patient with severe kidney impairment.

Possible side effects of aliskiren include:

Strokes (a/k/a cerebrovascular accident (CVA) - rapid loss of brain function(s) due to disturbance in the blood supply to the brain i.e. bleed) Heart attacks Acute rental failure and other rental complications (renal = kidney)
Hyperkalemia (kidneys not functioning adequately)
Hypotension (abnormally low blood pressure)
Syncope (loss of consciousness)

Aliskiren was brought to market as Rasilez in Europe, and Tekturna in the U.S. by Novartis in 2007. It is approved as a treatment for hypertension (high blood pressure) either as monotherapy or in combination with other medications. Regulators in Europe began a review of aliskiren late last year, after Novartis announced it was shutting down its ALTITUDE study, which was designed to evaluate the effect of aliskiren on the likelihood of cardiovascular and kidney events in high-risk diabetic patients.

The ALTITUDE study was halted after an independent review committee noted higher adverse events in patients receiving Rasilez/Tekturna in addition to standard of care in the trial. There was also an increased incidence after 18-24 months of serious side effects in the high risk population, including non-fatal stroke, kidney complications, hyperkalemia (high potassium), and hypotension (low blood pressure).

In January, Novartis agreed to a request from European regulators to add new safety warnings to the labels of aliskiren products to reflect the findings of the ALTITUDE trial. Novartis also wrote to physicians world-wide recommending that patients with Type 2 diabetes shouldn’t be treated with aliskiren, or combination products containing aliskiren, if they are also receiving an ACE inhibitor or ARB.

Actos Maker Accused of Hiding Heart Side Effects in Whistleblower Lawsuit

Thu, 08 Mar 2012 00:00:00 -0800

A whistleblower lawsuit recently unsealed in Massachusetts federal court will likely raise more concerns about the safety of Actos. The whistleblower, a former medical reviewer for Takeda Pharmaceuticals, the maker of Actos, alleges that the company did not properly classify cases of congestive heart failure associated with the type 2 diabetes drug when they were reported to the U.S. Food & Drug Administration (FDA) Adverse Event Reporting System.

Congestive heart failure is a well-known Actos side effect. Since 2007, the Actos label has included a serious safety warning, a "Black Box," detailing this risk.

According to allegations made by Helen Ge, Takeda allegedly failed to classify “non-hospitalized or non- fatal” congestive heart failure cases as serious from late 2007 to January 2010. Ge claims Takeda was trying to make Actos appear safer than Advandia.

Avandia received a Black Box warning in 2007 because of its association with heart attacks, and sales of the drug were severely restricted in 2010. Actos was thought to be safer for the heart than Avanida. But last year, a study involving medical data from 28,938 people who took either Avandia or Actos found that that about 4 percent of each group died from heart failure or a heart attack.

“Takeda’s motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos’s safety profile and to increase sales,” Ge said.

Pharmaceutical companies are required to report drug side effects to the FDA. But according to Ge, Takeda directed its medical reviewers to "change their professional opinion regarding the classification of Actos adverse events” on multiple occasions between 2007 and 2010. Ge also claims that when she protested, her contract with Takeda was terminated.

Ge's lawsuit was brought under the federal False Claims Act, which allows private citizens to bring suit in instances of fraud against the federal government.

“Takeda’s fraud has caused tens of thousands of false claims to be made on federal and state health care programs,” causing “hundreds of millions of dollars” in damages, Ge alleges.

The Justice Department has declined to join Ge's Actos whistleblower lawsuit, but she has decide to pursue it on her own. If she prevails and recovers damages on behalf of the government, Ge will be entitled to as much as 30 percent of the recovery.

Pradaxa Wrongful Death Lawsuit Filed on Behalf of Tennessee Woman who Suffered Gastrointestinal Bleeding

Wed, 07 Mar 2012 00:00:00 -0800

What may be the first wrongful death lawsuit involving Pradaxa bleeding side effects has been filed by the family of a woman in Tennessee. The lawsuit alleges that the deceased plaintiff suffered a fatal gastrointestinal bleed due to her use of Pradaxa.

In the U.S., Pradaxa was approved for use to prevent strokes and blood clots in people with atrial fibrillation in October 2010, but has been available overseas since 2008. In recent months, however, as the number of people using Pradaxa has increased so to have concerns about its possible bleeding side effects. Like most blood thinners, Pradaxa carries a risk of bleeding. However, while warfarin, the blood thinner was meant to replace, there is no antidote to Pradaxa bleeding.

In December, the U.S. Food & Drug Administration (FDA) said it was evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa, but did not indicate how many such reports it had received. However, the month prior the drug's maker had acknowledged receiving 260 reports of fatal bleeding among Pradaxa patients worldwide, including 12 reported in the U.S.

According to her family's lawsuit, Nancy Brummett was hospitalized with a gastrointestinal bleed after having been prescribed Pradaxa in January 2011. At the time, she had been taking Pradaxa for about two months. She was released from the hospital, but subsequently died, less than three months after she began using Pradaxa.

Her family's lawsuit alleges that Pradaxa's maker, Boehringer Ingelheim, created a defective product that is no safer than older blood thinners, and lacks an antidote for reversing bleeding side effects. The lawsuit argues that important information about the lack of an antidote was buried in small print in a medication guide under the heading of “overdose.” The complaint also alleges that Boehringer failed provide any guidance on how to deal with bleeding events when they arise, the lawsuit claims. Finally, the lawsuit faults the 150 mg standard dosing for Pradaxa, pointing out that warfarin is dosed specifically for individual patients.

Gilenya Safety Review Hits Sales

Wed, 07 Mar 2012 00:00:00 -0800

Eleven deaths among people taking the multiple sclerosis drug Gilenya have caused it to lose market share since it hit the U.S. market in late-2010.

According to a Bloomberg report, Gilenya’s share of the market for immunomodulatory drugs used in the treatment of MS from from 6.2 percent to 6.1 in February. This drop marks the first time the drug has dipped in this rating since it was introduced in September 2010.

Skepticism of the overall effectiveness of Gilenya in treating MS has been raised recently with reports of 11 patient deaths, specifically some of those who died after taking their first dose of the drug. Late last year, the makers of Gilenya, Novartis, acknowledged the death of a U.S. patient who died within a day of taking it.

Chief among the side effects of Gilenya is its ability to impact heart rhythm. Though Gilenya has not been blamed for the deaths, those taking the drug at the time of their unexpected death were attributed to cardiac complications, including three deaths due to heart attack in Europe. Just more than half the 11 deaths remain “unexplained.”

In response to this recent news, the Food and Drug Administration and some other regulators worldwide have issued updated safety guidelines regarding Gilenya prescriptions. In the U.S., a patient’s first dose of the drug should be administered in a physician’s presence and that patient should be monitored for at least six hours after it’s taken, specifically monitoring the heart for any signs of complications.

Though Novartis has not issued much detail in the cases of the patient deaths, it is likely that people who are already being treated for heart problems like irregular heart beats, low or high blood pressure, or take beta blocker drugs may be more likely to experience complications when taking Gilenya.

The FDA, Health Canada, and the European Medicines Agency are all conducting safety reviews of Gilenya in response to the recent deaths. A total of about 30,000 people worldwide take Gilenya to treat symptoms of MS and to slow physical disability caused by the disease. Gilenya is the first approved pill drug for the treatment of multiple sclerosis.

News of Gilenya’s drop in market share for MS drugs lowered its overall expectations. Analysts cited by Bloomberg believe sales of the drug will peak in 2016 at $1.96 billion annually, a 12 percent drop from the previous forecast. Gilenya’s presence as the only pill-form MS drug is not expected to last much longer, and that could impact future sales if the questions surrounding these and potentially more patient deaths persist. Bloomberg indicates Biogen Inc. is seeking approval of its own pill-form MS drug, BG-12.

Drug Side Effects, Lawsuits, Lawyer, Attorney | Harmful Side Effects, Recalls, Pharmaceutical Litigation Lawyers, FDA Drug Recalls | Personal Injury

Wed, 07 Mar 2012 00:00:00 -0800

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