Januvia is Merck’s fastest- and greatest-selling product since it was approved in 2006. It is the one product that often drives the drug maker’s quarterly earnings, according to a Reuters report. But that has not been the case recently.

Merck’s shares fell 1.6 percent in the face of investor concern about slower Januvia growth. "This was an inflection point for Januvia," Morningstar analyst Damien Conover told Reuters. "The drug is maturing and will see significant but slower growth over the next few years as the market gets more competitive." Januvia sales fell 4 percent to $884 million.

Januvia is one of a number of diabetes medicines under investigation by the U.S. Food and Drug Administration (FDA) over links to pancreatic cancer.

Diabetes drugs manufactured by Merck & Company Inc., AstraZeneca PLC, and other drug makers are involved in claims that the medications, when compared to other diabetes drugs, are 25 times likelier to increase pancreatic cancer rates, according to a prior Law360 report. Watchdog group the Institute for Safe Medication Practices (ISMP) reviewed a year of adverse event reports made to the FDA related to five Type 2 diabetes medications, including Merck’s Januvia; Byetta, manufactured by AstraZeneca and Bristol-Myers Squibb Co.; and Tradjenta, made by Eli Lilly & Co.

According to the research, 105 cases of pancreatic cancer were reported in patients taking these drugs compared to two cases of patients being treated with drugs from a different class of diabetes medication.

This March, the FDA initiated a probe based on a medical journal study that found that the drugs, known as incretin mimetics, may lead to increased risks for pancreatitis, as well as precancerous cellular changes known as pancreatic duct metaplasia, said Law360. The European Medicines Agency (EMA), Europe’s top drug watchdog group, implemented its own recommendation following the FDA’s probe.

Incretin mimetic drugs include Byetta and Bydureon (exenatide); Victoza (liraglutide); Januvia, Janumet, Janumet XR, and Juvisync (sitagliptin); Onglyza and Kombiglyze XR (saxagliptin); Nesina, Kazano, and Oseni (alogliptin); and Tradjenta and Jentadueto (linagliptin). Incretin mimetics increase certain natural substances that lower raised blood sugar levels.

Diabetics either have abnormally low insulin levels or their bodies are unable to utilize insulin efficiently. Incretin mimetics imitate the body’s incretin hormones, which are supposed to stimulate insulin release following meal consumption. These hormones are also typically used in collaboration with diet and exercise to lower blood sugar in adults diagnosed with Type 2 diabetes.

In 2009, the FDA required a label update on these drugs that warned of the risk of acute pancreatitis, a painful, potentially fatal disorder and a known risk factor for pancreatic cancer. Pancreatitis is an inflammation of the pancreas linked to cancer and kidney failure. Chronic pancreatitis is painful, potentially fatal, and a known risk factor for pancreatic cancer.

Merck is the focus of a wrongful death lawsuit being heard in Illinois state court; it alleges that three people developed pancreatic cancer from taking Januvia. The plaintiffs claim that Januvia is defectively designed and lacks adequate warnings about its alleged association with a significantly increased risk of developing pancreatic cancer, said Law360.

Prior research revealed that Januvia and Byetta have been associated with reports of increased risks for pancreatic and thyroid cancers. Another new study also found that the drugs may double patients’ risks for developing pancreatitis, the first time a study numbered the ones at risk. In the United States, about 8.6 percent of the population—or some 25 million people—were diagnosed with diabetes in 2010, based on prior Bloomberg News data. That number is expected to rise to more than 34 million by 2020.

The study found that Samsca (tolvaptan) should be used no longer than 30 days in patients with no underlying liver disease and should never be used by patients diagnosed with underlying liver disease, said Renal & Urology News.

A selective vasopression V2-receptor antagonist, Samsca is indicated for the treatment of patients who are diagnosed with hypervolemic and euvolemic hyponatremia. Hypervolemic and euvolemic hyponatremia are electrolyte disturbances in which the body suffers from a lower-than-normal sodium ion concentration in the serum.

In trials evaluating Samsca in patients with autosomal dominant polycystic kidney disease, Samsca was shown to increase risks for liver injury, said Renal & Urology News. Autosomal dominant polycystic kidney disease (ADPKD) is a genetic disorder in which many cysts form in the kidneys, causing the kidneys to become enlarged. Samsca is not FDA-approved for the treatment of ADPKD.

Samsca’s manufacturer, Otsuka, and the FDA will be updating the drug label to reflect the revised information.

According to the FDA, "Samsca treatment should be stopped if the patient develops signs of liver disease. Treatment duration should be limited to 30 days or less, and use should be avoided in patients with underlying liver disease, including cirrhosis.

“Patients should be aware that Samsca may cause liver problems, including life-threatening liver failure, and should contact their health care professional to discuss any questions or concerns about Samsca."

Otsuka previously said that patients taking Samsca who are diagnosed with underlying liver disease that may cause or contribute to hyponatremia may be less able to recover from drug-induced liver injury. Otsuka recommended healthcare providers order liver tests for any patient taking Samsca with symptoms consistent with hepatic (liver) injury:

• Fatigue
• Anorexia
• Discomfort in the upper, right abdomen
• Dark urine
• Jaundice.

As early as 2004, Takeda’s internal studies found links to bladder cancer, a lawyer for the plaintiff, Jack Cooper, told a Los Angeles state court jury yesterday, as noted in a Bloomberg report. Takeda had kept mum because the drug’s annual sales were about $1.6 billion, he added.

Bloomberg quoted Miller as saying: “Selling diabetes drugs is big business in America… But companies are not allowed to downplay the risk [of their drugs]…”

The key issue for jurors is determining whether Takeda should be held liable for failing to warn patients and doctors of Actos’s potential to cause bladder cancer. Defense lawyers are expected to pitch their closings arguments today, which means the jury may begin deliberations today as well.

Cooper had been taking Actos for more than two years when he was diagnosed with bladder cancer in November 2011. He “is gravely ill,” in the words of Judge Kenneth Freeman, who is presiding over Cooper’s Los Angeles-based lawsuit. The judge expedited the trial due to Cooper’s condition, Bloomberg reported.

Cooper’s lawsuit – which has run on for about two months, so far – revealed that, according to internal Takeda emails, company executives had worked to convince the U.S. Food and Drug Administration (FDA) that there was no need to place a heightened bladder cancer warning on the Actos label.

When the FDA did begin a campaign to get the biggest drug maker in Asia to update its Actos labels in 2005 and 2006, Takeda executives “stalled and delayed,” the plaintiff’s attorney told the jury, as reported by Bloomberg. The attorney added that U.S. law places the onus on Takeda to fully disclose any risks linked to its products.

Actos first appeared in the market back in 1999, following its approval to treat Type 2 diabetes. Then, in 2011, the FDA finally got the updated Actos safety label it had wanted, which revealed that the drug may increase the risk of bladder cancer following one year of use. The warning was based on an ongoing 10-year study by Kaiser Permanente.

Other research continued to support the association between Actos and bladder cancer. In May 2012, the British Medical Journal (BMJ) published a study showing that patients were twice as likely to get bladder cancer after taking Actos for two years. In July 2012, the Canadian Medical Association Journal published a study showing that Actos use was linked to a 22% increased risk of developing bladder cancer.

Takeda is facing more than 3,000 suits alleging that its Actos drug caused bladder cancer as well as other ailments, according to court records, as reported on by Bloomberg.

More cases are pending in Illinois state court, according to court dockets; more than 1,200 lawsuits have been consolidated before a federal judge in Louisiana for pretrial information exchanges – with the first federal case due to reach the courtroom in January 2014. 

The Transfer Order filed on April 8, 2013, states that the MDL currently consists of eight cases in eight different districts, and that all but one alleges that the Mirena® IUD migrated from its intended position and perforated the uterus, causing related injuries. The Order went on to say that since the motion has been filed, the Panel has been informed of more than 40 related actions.

The Mirena® IUD was released in 2000. The small, t-shaped plastic device is attached to two strings and works to prevent pregnancy by releasing the hormone levonorgestrel. Placed in the uterus by a health care professional, the Mirena® provides a long-term form of contraception that may be left in the uterus for up to five years.

According to the U.S. Food and Drug Administration (FDA), the most serious side effects associated with the Mirena® IUD include:

• Perforation of the uterine wall
• Embedment of the device in the uterine wall
• Intrauterine pregnancy
• Ectopic pregnancy
• Group A streptococcal sepsis
• Pelvic inflammatory disease (PID)

Mirena® IUD injuries require surgical removal of the Mirena® and may also lead to other serious injuries and infections. Some injuries are long term; some permanent.

In 2009, Bayer Healthcare Pharmaceuticals Inc., the maker of the Mirena® IUD, was reprimanded by the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) for overstating the benefits—and neglecting to mention the risks—of Mirena® in the company’s “Simple Style” program.

“We are glad to see that the litigation is moving forward,” said Matthew J. McCauley, Senior Litigation Counsel at Parker Waichman LLP. “By centralizing these cases to one court before one judge, cases can be processed more efficiently.” The centralized MDL is In Re: Mirena IUD Products Liability Litigation, MDL No. 2434.

About 75 cases have been filed in New Jersey state court; 50 other cases have been filed in federal courts nationwide. Plaintiffs’ attorneys believe this number will continue to rise, especially given that about 2 million women use the Mirena® worldwide. Parker Waichman has filed 50 of the 60 Mirena® IUD lawsuits pending in the Superior Courts of New Jersey. Mirena® lawsuits allege that the IUD is inherently defective, creates an unreasonable risk of injury to women, and that Bayer Healthcare Pharmaceuticals, Inc. failed to warn consumers about the risks associated with the Mirena® IUD.

Propecia (finasteride, 1 mg) was approved in 1997 to treat male pattern baldness and is part of a class of drugs known as 5-alpha reductase inhibitors (5-ARIs). Propecia’s active ingredient is known to interfere with male hormones, including testosterone derivatives.

In higher doses, finasteride is sold under the brand name Proscar, and has been approved to treat men with benign prostatic hyperplasia (enlarged prostate) or urinary problems.

To date, over 400 lawsuits are pending in state and federal courts over Propecia. These lawsuits allege that the side effects include loss of libido, erectile dysfunction, and infertility.

Last April, Merck agreed to change its label warning to indicate that sexual problems could possibly persist even after Propecia treatment has been stopped, said Lawyers USA Online. The stronger warnings were ordered by the U.S. Food and Drug Administration (FDA), for both Propecia and Proscar labels.

Until the FDA ordered the label change, prior warnings suggested that the side effects typically disappeared once the medication was stopped. However, several years ago, Merck changed the Propecia label in Europe to warn that the drug could lead to permanent erectile dysfunction.

More than 140 lawsuits have been consolidated in multidistrict litigation in the U.S. District Court for the Eastern District of New York and over 50 cases in New Jersey state courts have been consolidated. Plaintiffs in these cases allege that Merck was aware of the risks of ongoing side effects, pointing out that Propecia labels in other countries were changed as far back as 2008 and included mention of those risks, Lawyers USA Online noted.

A recent report revealed that Propecia-related sexual side effects in some men may be permanent— but this is not the first time hair-loss medication has been linked to the condition. Consumer advocacy group The Institute for Safe Medication Practices (ISMP), in the FDA Adverse Event Reporting System (FAERS), found evidence of persistent Propecia side effects.

“Nearly 20 years after approval, evidence is now emerging that the sexual side effects of finasteride may sometimes be irreversible and were most notable in the younger men taking finasteride for male pattern baldness,” the ISMP study said, wrote QuarterWatch.

Prior studies that have reported potential links between Propecia and sexual side effects also have included diminished sex drive and orgasm problems, in addition to erectile dysfunction. Other research has suggested that using Propecia is associated with depression. Potential complications were seen to possibly persist for years after treatment was stopped.

In recent months, Pradaxa also has been linked to injuries and deaths related to uncontrollable bleeding.

University of North Carolina researchers found that Pradaxa blocks a key component in the human blood clotting system, which may increase these viral infection risks. This includes increased risks for the flu and myocarditis, a cardiac viral infection that is a significant cause of sudden death in children and young adults, said News-Medical.

For some 50 years, patients diagnosed with atrial fibrillation, an irregularity of the heartbeat, and others who are at risk of forming life-altering blood clots, have been prescribed warfarin, an anticoagulant medication, explained News-Medical. The U.S. Food and Drug Administration (FDA) recently approved Pradaxa for atrial fibrillation patients.

Pradaxa is a blood-thinning medication used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF), a common heart rhythm abnormality. The drug, however, is not approved for patients with atrial fibrillation caused by heart valve problems. Pradaxa also inhibits thrombin, which is the central coagulation activator in the body’s blood clotting system, explained News-Medical.

When thrombin activity is blocked, normal coagulation activities are interrupted. And, although clot formation is reduced, the study suggests that immune responses are also reduced. "Our findings show that blocking thrombin reduces the innate immune response to viral infection," said the study’s senior author, Nigel Mackman, PhD, the John C. Parker Distinguished Professor of Medicine in the division of hematology and director of the UNC McAllister Heart Institute, according to News-Medical. "The use of the new generation of blood thinners might increase the risk and severity of flu and myocarditis," Mackman added.

Mackman also pointed out that "We are now determining if the traditional long-term anticoagulant warfarin has the same effect on viral infection or is this specific to the new blood thinner," News-Medical said. A report on the research appears in the March 2013 issue of The Journal of Clinical Investigation.

Another recent study revealed that Pradaxa should not be used for the prevention of stroke or blood clots in patients who have been implanted with mechanical heart valves. The FDA advised health care professionals and the public of the dangers of Pradaxa for patients implanted with these devices.

In fact, a clinical trial in Europe was ceased when Pradaxa users were seen to be likelier to experience strokes, heart attacks, and blood clots forming on the heart devices when compared to patients taking warfarin. The study also found that patients taking Pradaxa experienced more bleeding after valve surgery than those taking warfarin.

The use of Pradaxa in patients with valve replacements made of natural biological tissue has not been evaluated.

“Overall, these cases allege that GranuFlo and/or NaturaLyte caused injury or death in patients who used the products during hemodialysis,” said Matthew J. McCauley of Parker Waichman LLP, an attorney for the plaintiffs.

The suits allege that the products are defective and that the manufacturer, Fresenius, , failed to warn about the risks. According to court documents, GranuFlo and NaturaLyte can lead to metabolic alkalosis, causing a number of potentially fatal complications, including:

•     Low blood pressure
•     Hypokalemia (low potassium level)
•     Hypoxemia (low oxygen level)
•     Hypercapnia (high carbon dioxide level)
•     Cardiac arrhythmia
•     Cardiopulmonary arrest

An article published last June in The New York Times said that the U.S. Food and Drug Administration (FDA) began investigating whether Fresenius Medical Care had violated federal regulations by failing to warn consumers about the potentially deadly risks of GranuFlo and NaturaLyte. A 2011 internal company memo warned that 941 dialysis patients suffered cardiac arrest in Fresenius facilities in 2010, the Times said. The memo was sent to Fresenius facilities, but the information was not made public until the FDA prompted Fresenius to release it. 

In June 2012, Fresenius, in cooperation with the FDA, issued a Class I recall for GranuFlo and NaturaLyte, warning that the products may lead to high levels of bicarbonate in patients undergoing kidney dialysis. Class I recall is the FDA’s most serious recall status, reserved for situations in which there is a “reasonable probability” that use of the product “will cause serious adverse health consequences or death,” according to the FDA’s definition.

Acetaminophen, the active ingredient in Tylenol, is a popular over-the-counter (OTC) analgesic and fever-reducing medication. Because of broad familiarity with acetaminophen, many people are unaware that every form of acetaminophen carries risks for serious, even deadly, health affects. For instance, acetaminophen can lead to serious liver damage, and links have been made between acetaminophen use and asthma.

The 36-year-old man in this case had a history of alcohol abuse and ultimately suffered from toxic liver injury, said Kilkenny People. According to the Coroner’s Court, the man took paracetamol (acetaminophen) in a “normal manner.” His heart and muscles were deemed normal, he did not suffer bone or soft tissue injuries, and paracetamol was present in his blood. The man’s liver was pale and the liver’s cells dead, said Kilkenny People. A scientific examination revealed that the man’s paracetamol use led to his acute liver failure.

Acetaminophen can cause serious liver damage and research has found that many adults are at risk for unintentional acetaminophen overdoses. In fact, many patients may not know that the prescription painkiller they’re taking contains acetaminophen and were likely not warned to avoid adding other acetaminophen-containing products. From 1998 to 2003, acetaminophen products were the number one cause of acute liver failure in the United States. Of these, 38 percent were linked with accidental overdose.

It may take up to 12 hours to exhibit symptoms of acetaminophen overdose, which can include abdominal pain, appetite loss, diarrhea, nausea, upset stomach, irritability, jaundice, sweating, convulsions, and coma. Without immediate treatment, a large acetaminophen overdose can lead to liver failure, even death. According to a previous article published in the Los Angeles Times, acetaminophen single overdoses resulted in more than 40,000 calls to poison control centers in 2009; such overdoses are among the leading causes of acute liver failure. Small acetaminophen overdoses, when occurring over time—called “staggered overdosing”—can be fatal.

In 2009, the U.S Food and Drug Administration (FDA) mandated makers of acetaminophen-containing OTC drugs and fever reducers to include liver injury warning labels and to ensure that the medication’s active ingredients be prominently displayed on both the box and bottle. In 2011, the agency warned that acetaminophen-containing products may lead to severe liver damage, which led to a limitation of acetaminophen in any medication, as well as a black box warning—the agency’s most serious—to be included on the packaging of acetaminophen-containing products.

According to the FDA, liver damage can occur after taking Tylenol for only four days, and 44 percent of people taking a form of acetaminophen show signs of liver enzyme abnormalities.

The FDA has also said that more than 600 OTC and prescription medicines contain acetaminophen. Some medicines combine acetaminophen with other active ingredients to treat pain, cold symptoms, flu, allergy, and sleeplessness. To determine if an OTC drug contains acetaminophen, look for the word ”acetaminophen” on the Drug Facts label. The label may not always spell out the entire word or may have the abbreviation “APAP.”

The Supreme Court, which heard arguments from both sides on Tuesday, is expected to decide if manufacturers of generic drugs can be held accountable for any supposed design defects in their medications.  Under current federal law, manufacturers virtually replicate the exact composition of the branded versions of the drugs they mimic.

If the Supreme Court ultimately decides that federal law bars product defect claims under state law, the result would be: It will become practically impossible to hold a generic drug maker accountable for injuries that their own drugs generate.

The specifics of the case in question center on Mutual Pharmaceutical Co., which has asked the Supreme Court to overturn a $21 million jury judgment to Karen Bartlett, who successfully sued the generic drug maker in 2008 for injuries she was alleging had been caused by the company’s drug sulindac, a generic painkiller. She won the trial in 14 days.

The Boston-based U.S. Court of Appeals for the First Circuit upheld the award; Mutual then brought an appeal to the Supreme Court.

Doctors had diagnosed Bartlett as falling victim to a “rare hypersensitivity reaction associated with the drug,” Reuters reported. Bartlett’s skin peeled off and was replaced by lesions that ruptured across two-thirds of her body, keeping her in a hospital burn unit for months – part of which she spent in an induced coma. Since then, doctors have operated on her eyes 13 times -- but she is nearly blind, and also suffers from scarred lungs and a constricted esophagus.

As part of its effort to ask the Supreme Court to overturn the award, Mutual argues that federal law already bars claims such as Bartlett’s because the drug in question had already been approved by the U.S. Food and Drug Administration (FDA), and further, was already subject to federal law requiring generics to sport the same design as the branded drug it is seeking to mimic.

The company cites the 2011 Supreme Court ruling of  PLIVA v. Mensing -- which has killed in the crib a large volume of personal injury cases against generic drug manufacturers. In Mensing, the court found that generics were essentially protected by the federal law requiring them to have the same label as their branded counterpart.

During trial, Bartlett established the claim that sulindac was intrinsically hazardous and the design unreasonably dangerous and defective – a contention supported by the number of incident reports on skin reaction submitted to the FDA.

Mutual’s argument is that generic drug makers don’t control their product's design, which must imitate its branded opposite number.

About 80 percent of all U.S. prescriptions are filled with generics, according to healthcare information provider IMS Health.

Unfortunately for consumers, evidence shows that Fresenius knew about the risks of high bicarbonate levels long before the recall in 2012. Company officials have been aware of the metal alkalosis risk since GranuFlo and Naturalyte were approved in 2003. Even though Fresenius Medical Care knew that excess levels of bicarbonate were associated with serious, potentially fatal consequences the company did not warn clinics that used the products or the U.S. Food and Drug Administration (FDA).

An internal company memo, dated November 4, 2011, warned that 941 patients had suffered cardiac arrest inside Fresenius clinics in 2010. The memo attributed part of the problem to dosing errors, where doctors did not account for the extra alkalinity from GranuFlo and NaturaLyte. Fresenius did not warn outside consumers or the public about these risks until prompted by the U.S. Food and Drug Administration (FDA) on March 27, 2012. Only afterwards did Fresenius issue an Urgent Product Notification to non-Fresenius Clinics.

In June 2012, the FDA issued a Class I recall for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate. The agency warned about higher bicarbonate levels with these products, stating that “This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.”

A multidistrict litigation is created when complex litigation has common questions of fact; in this case, Mirena® IUD lawsuits allege that the IUD is defective and can spontaneously migrate outside of the uterus, causing injuries. By centralizing the lawsuits in one court before one judge, pre-trial proceedings will be more efficient and duplicate findings will be avoided.

Bayer’s Mirena®, an intrauterine device (IUD), received U.S. Food & Drug Administration (FDA) approval in 2000. A hormonal IUD that is placed inside the uterus by a healthcare professional, Mirena® can remain in the body for up to five years. Mirena® slowly releases the hormone levonorgestrel while implanted.

According to the FDA, the most serious adverse events associated with the device since its time on the market include:

• Perforation of the uterine wall
• Embedment of the device in the uterine wall
• Ectopic pregnancy
• Intrauterine pregnancy
• Group A streptococcal sepsis
• Pelvic inflammatory disease (PID)

According to the American Association for Justice (AAJ) - Mirena® IUD Litigation Group, the surgery required to remove the Mirena® IUD when it perforates and migrates outside the uterus can lead to a number of injuries, including organ damage, adhesions, and infections. Matthew J. McCauley, Senior Litigation Counsel at Parker Waichman LLP, co-chairs the Group.

The Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) reprimanded Bayer in 2009 for having overstated the benefits of Mirena® and failing to mention the device’s risks in the company’s “Simple Style” program.

The case is In Re: Mirena IUD Product Liability Litigation, Case No. 1:12-CV-2780.

According to a Reuters report, the FDA published a report this week on the developments of a clinical trial on the prospective Johnson & Johnson drug canagliflozin, a proposed new prescription drug treatment in the fight against type 2 diabetes. The agency said early results of a clinical trial of the drug show that increases a person's levels of bad cholesterol to the point where the drug poses heart risks to a patient taking it.

This side effect is bad news for diabetics, who are more often than not overweight or obese and face the greatest risk of diabetes-related death from heart disease. The FDA requires any new type 2 diabetes drug that gets its approval to be free of the risk of causing heart-related complications. This development obviously impedes this drug's progress past the agency and to prescribing physicians.

The agency also noted in its study that patients in the trial had also shown to have suffered adverse effects on their kidneys and increased fungal growth in the perineum and bacterial growth in the urinary tract, according to the report. A final review of the drug is expected on June 10 when FDA officials will vote on the drug's overall safety and whether or not to recommend it for approval.

The indications are that this panel may choose to send the drug back for more development, especially to work on lowering the risk of heart-related side effects or to at least identify certain patients who may be more at risk of suffering heart-related problems while taking canagliflozin. Testing during the trial to find out if taking the drug increased the risk of cancer of the kidneys, adrenal glands, testes, breasts, and bladder were negative.

If Johnson & Johnson is successful in getting canagliflozin approved for use, the company plans to market it as Invokana. 

If it is approved, it will join other drugs in a class known as SGLT2 inhibitors, a newer treatment of type 2 diabetes, a disease that is growing at a rate to be considered a public health epidemic. Millions of Americans have been diagnosed with type 2 diabetes and the disease figures to affect more Americans in the future as lifestyles become more sedentary and diets become more unhealthy.

Current and previous drug treatments for type 2 diabetes have only enjoyed moderate levels of success but many people taking them have suffered serious and sometimes fatal side effects of the drug.

He is being represented in his lawsuit by the national law firm of Parker Waichman LLP. The firm represents a growing number of Actos-related bladder cancer victims and its founding partner, Jerrold S. Parker, was named to serve on the Plaintiffs' Steering Committee in a federal Multidistrict Litigation filed against the makers of the drug. This latest lawsuit was combined with those other lawsuits in Re: Actos (Pioglitazone) Products Liability Litigation (MDL No. 6:11-md-2299). 

This lawsuit and the MDL are filed in U.S. District Court for the Western District of Louisiana. The lawsuits claim that Takeda Pharmaceuticals and Eli Lilly & Co. knowingly hid evidence that showed taking this particular diabetes drug – especially at high doses or for a prolonged period of time – could lead to bladder cancer.

The complaint joins other and a growing number of similar lawsuits all making similar claims. MDL are approved by a federal judicial panel and combine lawsuits which make like claims. The process streamlines the pre-trial process and decides on matters of admission of evidence, approved witnesses, and other matters that could be used as grounds for appeal after a decision has been reached. The MDL process aims to eliminate the basis for any appeals.

In the Actos MDL, Takeda Pharmaceuticals America, Inc., Takeda Pharmaceuticals USA, Inc. f/k/a Takeda Pharmaceuticals North America. Inc., Takeda Pharmaceutical Company Limited and Eli Lilly and Company have been named as Defendants.

The North Carolina man says he was prescribed Actos in 2002 and after taking the drug for a short while, he developed bladder cancer. He believes that Takeda was aware of the risk of bladder cancer associated with the drug but failed to inform the public of this risk in favor of higher sales for more than a decade.

Revenues generated from Actos sales have boosted since the previous top-selling diabetes drug, Avandia, was essentially removed from the market by the Food and Drug Administration due to its link to several life-threatening side effects like heart attack and stroke. 

Actos was formally approved by the FDA in July 1999 but it was not until last year that the agency first informed the public of this dangerous side effect risk. The FDA formally added a Black Box warning to Actos safety information that notes taking the drug for more than a year can increase the risk of suffering bladder cancer, a life-threatening disease.

A recent study showed that taking Actos over another type 2 diabetes medication could increase a person’s risk of developing bladder cancer by 22 percent.

A new report published this week at the Web site FoodConsumer.org calls attention to a newer form of type 2 diabetes drug emerging on the market, Januvia. Januvia is manufactured by Merck is the drug sitagliptin and was first approved by the Food and Drug Administration in 2006. Januvia belongs to a class of drugs known as Dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors). The join other hypoglycemia drugs on the market that work by reducing glucagon and blood glucose levels.

Januvia is quickly emerging on the market mostly because of two main factors, the amount of people being diagnosed with type 2 diabetes is constantly on the rise. Estimates show that 1 in 3 children today will grow up and eventually be diagnosed with type 2 diabetes. Blame a sedentary lifestyle and poor dietary choices as a society for the rapid rise in the disease.

Diabetics who've experienced futile results on other type 2 diabetes drugs or those who've suffered serious side effects while taking other drugs may be more likely to turn to Januvia. Previous leading drugs in the fight against type 2 diabetes - Avandia and Actos - have been plagued by negative press since they rose to the top of sales charts among other drugs designed for the same purpose. Avandia has all but been removed from the U.S. market due to a link to fatal heart attacks, strokes, and blood clots. In its place has been Actos, a drug that has hidden under the shadow of Avandia but with that drug now out of the way, has also been plagued by marks against its safety record. Actos has been linked most notably with life-threatening blood cancer.

Those turning to Januvia may very well be facing similar risks from a different set of life-threatening side effects. Though research on Januvia is limited currently, the drug has already been positively linked to serious side effects including low blood sugar levels, allergic reactions and anaphylaxis, swelling of the lips and tongue, acute pancreatitis, and death.

Januvia works by interfering with a diabetic's immune system and to date there has been no hard evidence to suggest that the drug has any immunosuppressive side effects. One ongoing study has concluded that people taking Januvia face double the risk of suffering a lung infection compared to those taking a placebo drug.

The report at FoodConsumer.org also pointed to other unpublished (as of now) studies on the effects of Januvia, some effects that can far more severe consequences. Januvia has been associated with an increased rate of cancer among people taking it compared to other type 2 diabetes drugs and there have already been reports of people who've developed pancreatic, thyroid, colon, and prostate cancers, as well as melanoma skin cancer.

The Food and Drug Administration, according to an Associated Press report, has informed more than 350 health care clinics and other facilities that dispense Botox injections that imports of the product from Canada have not been approved by the agency and therefore may be dangerous and should not be used. The FDA said that shipments from companies owned by the pharmacy company Canada Drugs is responsible for the illegal exports.

This has been the fifth time that the FDA has been forced to issue warnings about the dangers and illegal nature of importing unapproved drugs from another country, according to the report. In announcing that rogue supplies of Botox may currently be being dispensed at clinics across the U.S., the agency also warned doctors not to purchase any drugs from Canadian pharmacies because they have not been approved for use in the U.S.

Earlier this year, the FDA warned 19 separate clinics that they had received counterfeit or unapproved shipments of the cancer drug Avastin. Three other times, the agency again warned about counterfeit Avastin shipments. Those warnings also centered around shipments made from suppliers north of the border that are owned by Canada Drugs.

The report from CBC.ca indicates that drug shortages, especially of injectable drugs only readily available at health care clinics, have led some doctors and clinics to seek other sources of popular drug treatments, such as Botox and Avastin.

In similar actions against Canada Drug earlier this year, the FDA also ordered the owners of more than 4,100 Web sites that dispensed drugs from Canada to stop selling to the U.S. and shut down immediately. AP indicates that all those sites, all owned by Canada Drug, are still functioning and in business this week.

The Food and Drug Administration said this week that WOW is really just another product in disguise and the agency has already determined that the original product is dangerous and could result in serious side effects and maybe death for people who take this specific product.

It was only earlier this year that the agency warned the public that the dietary supplement marketed as "all natural" Reumofan Plus actually contains hidden pharmaceutical ingredients. Any product that contains pharmaceutical agents must be approved by the FDA and millions of packages of dietary supplements like these products are able to reach the consumer market by failing to disclose the fact that they contain these products.

Instead, dietary supplements often purport to contain "natural" ingredients. In the case of WOW - really just the repackaged Reumofan Plus - the supplement is taken in the treatments of bone cancer or arthritis. If a dietary supplement product contains and undeclared ingredient, the agency works to warn the public of this fact and the risks associated with taking such products. It also begins a process to get these and other products off the market.

An agency spokesman said this week that several manufacturers of WOW are simply taking unsold supplies of Reumofan Plus and putting a WOW label on them and selling them back to consumers. The FDA said that WOW is being sold through online distributors and also at the retail level in some locations. 

The FDA said it has received dozens of reports of serious injuries that have resulted from people taking Reumofan Plus. The agency said that a few reactions have been fatal but did not specify an exact amount. Most often, people who experience dangerous side effects from taking Reumofan Plus suffer from liver injuries, severe bleeding episodes, corticosteroid withdrawl syndrome, adrenal suppression, and stroke.

According to the FDA's statement based on its research, samples of WOW contained the same undeclared ingredients as Reumofan Plus, including dexamethasone, diclofenac sodium, and methocarbamol.  Officials urge anyone taking either Reumofan Plus or WOW to stop taking it immediately and to consult their physician to determine if any injuries have resulted from taking this particular supplement.

The firm represents several victims who’ve suffered serious injuries caused by the Mirena^® IUD contraceptive device. Like other lawsuits the firm has filed on behalf of Mirena^® IUD victims, the latest claims that Bayer hid evidence of the dangers of its device and further, created a deceptive marketing campaign that targeted its specific prospective recipients of the device. This campaign knowingly glossed over the dangerous side effects of Mirena^® IUD while promoting it as a means for “busy moms” to help increase their libido and make them look and feel better.

In this latest case, the Missouri woman was implanted with Mirena^® IUD during a 2009 procedure. By the end of the next year, after experiencing little complication with the device until just before then, the woman began suffering from severe pain. A trip to the emergency room and an ultrasound revealed that the Mirena^® IUD device had perforated her uterus and migrated from the location where it was originally implanted.

This complication is not uncommon for many Mirena^® IUD recipients. If the device does migrate from the uterus, it could lead to an unintended and dangerous pregnancy that puts both a baby’s and the mother’s life at risk.

Bayer had ample evidence showing that this was one of several potentially serious complications that a Mirena^® IUD recipient could face while they have the device implanted to prevent pregnancy. This and other side effects - common side effects like weight gain and acne - were conspicuously left out of the company’s “Simple Style” program that was created as a means of marketing this new contraceptive.

Like a social network, the “Simple Style” program was targeted at women who’ve already had one child (the only approved would-be recipients of Mirena^® IUD). It attempted to have women share their success stories while using the Bayer device, all while downplaying the side effects that were commonly associated with it. Instead, by targeting so-called “busy moms” with the Mirena^® IUD device, Bayer promoted a return to a lifestyle these women may have enjoyed previously all while preventing pregnancy. The company sold women on the belief that Mirena^® IUD could have positive effect on their libido and help them “look and feel great.”

On its warning label, Bayer only notes the risk of uterine perforation exists when the device is being implanted, not spontaneously as it has for many women who’ve received the device. In this latest case, the Missouri woman had to endure a laproscopic surgery to remove the Mirena^® IUD device.

Her lawsuit seeks damages for severe and permanent physical injury, substantial pain and suffering, and economic losses due to increased and unforeseen medical expenses and missed time from work.

According to a WebMD.com report, people who take aspirin on a daily basis are more likely to develop age-related macular degeneration, or AMD. The risk was only noticed among people who had taken aspirin regularly at least 10 years prior to developing the eye disorder. Regular doses of aspirin is considered two pills per week for three months. 

Researchers say the risk is highest that a person who regularly took aspirin that they would develop neovascular AMD, which is also known as wet AMD. This condition is typically more severe than a related disease known as dry AMD. The study conducted at University of Wisconsin School of Medicine is published in the most recent edition of Journal of the American Medical Association.

People who take aspirin regularly are twice as likely to deevelop wet AMD but the overall risk is relatively low because the condition is not common among everyone who takes aspirin regularly. About 1 percent of all people over the age of 40 are likely to develop wet AMD, according to the WebMD.com report.

This study adds to conflicting evidence on the risks of macular degeneration associated with taking aspirin. For millions of Americans, taking aspirin is a common, almost everyday practice. The report suggests as many as 1 in 5 American adults takes aspirin to either reduce fever or pain, or in the prevention of heart attacks. Many don't consider the risks of taking aspirin and generally believe there are no side effects to taking it, certainly none as serious as this eye condition. 

Researchers noted that people who took aspirin regularly just five years ago were not likely to develop AMD for at least another five years, if aspirin were to be the cause. They believe that the overall benefits a person may gain in preventing heart attacks by taking aspirin outweigh the risks associated with AMD.

According to a recall statement issued through the Food and Drug Administration this week, the presence of Carboplatin crystals in some vials obtained during a routine sampling of the injectable drugs is what has prompted the recall issued in conjunction with Hospira. The company's customers were notified of this recall late last month. 

The recall is necessary because injectable drugs that contain particulate matter could cause serious injuries and possibly death in some scenarios. According to the recall statement, injectable drugs containing particulate matter "may potentially become lodged in and obstruct blood vessels, potentially causing local infarction, thromboembolism and vasculitis. Chronically, following sequestration, granulomatous formation in the lungs is possible."

Carboplatin is prescribed in the treatment of ovarian carcinoma in established combination with other approved chemotherapeutic agents, the recall statement notes. It is also indicated for palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with Cisplatin. 

The following Lots are included in the recall: 

* Carboplatin Injection, 450 mg/45 mL, 10 mg/mL, Cytotoxic Agent, 45 mL Multi Dose Vial
* Carboplatin Injection, 600 mg/60 mL, 10 mg/mL, Cytotoxic Agent, 60 mL Multi Dose Vial
* Carboplatin Injection, 450 mg/45 mL, 10 mg/mL, Cytotoxic Agent, 45 mL Multi Dose Vial, NOVAPLUS™

Affected Lots of the drug included the recall were distributed nationwide and to Puerto Rico from March until September of this year. Hospira reports that it has not received any adverse event reports linked to these defective drugs. The company says it also has not received any other reports from customers that say they found particulate matter in any vials it already distributed. 

Hospira told the FDA that it has launched an internal investigation that aims to determine the root of the problem that led to the particulate matter in the vials. 

Forbes.com reports on a new study from researchers at University of Rhode Island who found the drug orlistat, sold over-the-counter as alli and in prescription form as Xenical, increase a person's risk of experiencing "severe toxicity" of their liver, kidneys, or other internal organs. Several other studies have suggested such a link between alli and Xenical and this study, released this week, confirms those previous reports.

The study was funded by the National Institutes of Health. It is published, in part, in the journal Biochemical Pharmacology.

alli has become one of the fastest-selling weight-loss drugs on the market. As more people turn to weight loss drugs to combat obesity, they are turning to alli and if they face more serious obesity concerns, could opt for its prescription-strength counterpart Xenical. The dangers of taking these drugs, combined with their increasing popularity, prompted the Food and Drug Administration to issue a warning about the dangers of liver toxicity associated with these drugs. That warning suggested the risks were very low and that it only had one report of liver toxicity from a person who took orlistat.

Though previous studies have suggested that taking alli or Xenical could cause serious liver and kidney damage, this new study suggests these drugs could present an even more serious reaction. The report states that people taking Xenical or alli (orlistat) face a risk of inhibiting the effectiveness of other drugs they may be taking. According to the report, taking orlistat impairs the "metabolic action reduces the effectiveness of many medications, including life-saving cancer treatments. In fact, the researchers reported that cancer cells multiplied faster under the influence of orlistat. Orlistat also boosts the anti-clotting effects of aspirin, raising the risk of bleeding both internal and external."

According to a Reuters report, Massachusetts announced the closure of one pharmacy and the partial closures of two more as it continued to crack down on companies like them operating in the state. The crackdown was sparked after a deadly outbreak of fungal meningitis was linked to New England Compounding Center, a Framingham company that produced contaminated vials of methylprednisone acetate. The vials were tainted with a fungus that led to the oubreak.

As many as 14,000 vials were shipped from NECC's facility earlier this year and reached more than 70 pain management and health care facilities in 23 states. Thousands of the vials were dispensed before Food and Drug Administration testing on sample vials detected the presence of the toxin. By then, widespread reports of fungal meningitis were filtering from different parts of the country. At the root of the shipments was NECC.

Investigations showed that conditions inside NECC were unfit for processing pharmaceuticals and the operation was closed entirely as the inquiries continued. Those investigations shows that officials with NECC, and its sister company Ameridose, were serving as part of Massachusetts' Board of Pharmacy, the regulators that had been tasked with oversight of companies like NECC and others.

Lax oversight on the part of Massachusetts' Board of Pharmacy likely led to slipshod conditions at NECC and other pharmacies that have since been either closed, partially closed, or put on notice since the outbreak. On Nov. 21, Oncomed Pharmaceuticals was closed entirely by the state. Officials were "concerned about how it stored chemotherapy drugs" and ordered the pharmacy company closed. Undergoing partial closures were Pallimed Pharmaceuticals and Whittier Pharmacist. Both those locations were closed amid concerns over the sterility at each.

Each company has opportunities to reopen if they can raise their standards to meet those imposed by the state. 

To ensure that the state's Board of Pharmacy is properly tasked with oversight of these companies in the future, the state has appointed new members to the group to alleviate it of any political interference that likely allowed these companies to operate under these conditions and put the public's safety at risk.

In a statement from the Board's Interim Commissioner announcing the new appointments it was said, "These respected health care professionals will use their experience to bring change to the Board of Pharmacy to enhance our oversight of this industry. We expect additional changes to the board after the Commission on Pharmacy Compounding issues its recommendations to Governor Deval Patrick at the end of the month."

A new study from University of Virginia School of Medicine shows that women who have polycystic ovarian syndrome (PCOS) are more likely to develop blood clots while taking a birth control pill than women who do not feature this hormonal abnormality. This study appears in the most recent edition of Canadian Medical Association Journal. The research indicates that women suffering from PCOS who take an oral contraceptive are doubling their risk of suffering a blood clot, but the overall risk is still relatively low. 

About 5 to 10 percent of all women currently are diagnosed with PCOS. The hormonal condition can cause irregular menstrual cycles and women with PCOS are often found to have ovarian cysts. 

The study from University of Virginia researchers examined equal amounts of women diagnosed or not diagnosed with PCOS, more than 43,000 of each. It appears based on the research that a PCOS diagnosis, alone, increases a woman's risk of developing blood clots. For women taking birth control pills while diagnosed with PCOS, the risk of a blood clot was double. For women with PCOS but not taking a birth control pill, the risk was 1.5 times higher than the average risk of a blood clot.

Based on the results of this study, researchers in Virginia believe that physicians should reconsider the use of oral contraceptives for women with PCOS. The threat of thromboembolism for these women, although small, is serious as this side effect can often produce life-threatening reactions, like a heart attack or stroke. For some women, like those over the age of 35 or for those who smoke while diagnosed with PCOS, the risk is amplified even more and one study author suggested that physicians avoid prescribing birth control pills for these women altogether. 

This study adds to research showing the dangerous side effects of taking oral contraceptives. Canadian Medical Association Journal recently published another study recently that showed the same dangerous posed by contraceptives containing the hormone drosperinone. These include newer contraceptives like Yaz, Yasmin, and Ocella, which many other studies have linked to this life-threatening side effect of blood clots. 

This new research shows that all forms of oral contraceptives pose this same risk.

According to a CNN.com report, the makers of the generic form of Lipitor, one of the most popular cholesterol drugs, have issued a recall on 41 Lots of atorvastatin after they were found to potentially have specks of glass contaminating them. These pills could cause serious injuries if anyone were to take them.

The recall on atorvastatin was issued more than three weeks ago by Ranbaxy Pharmaceuticals but it took until just this week for the FDA to issue a warning to the public advising them of the recall and to not take the drug. Last week, Ranbaxy agreed with the FDA that it should stop manufacturing atorvastatin, a popular generic drug, until they could determine how the affected Lots became speckled with glass particles. 

Swallowing small glass particles can lead to serious internal injuries. Small pieces of glass can lead to small but serious lacerations or organ damage and cases of severe internal bleeding. 

Despite the recall and warning from the FDA, at least one wholesale pharmacy said it was advising its customers who received atorvastatin from them to continue using the drugs - even though they are likely included in the recall - as though no actions have been taken. The spokesperson at Express Scripts said the company would not be offering refunds or replacements for its customers who believed they might have the recalled atorvastatin pills.

The FDA urges recipients of atorvastatin to contact their pharmacies to determine if they have the recalled drugs in their home but the report indicates that a pharmacy determining from which Lot their pills were picked from may be nearly impossible.

This is Ranbaxy's first recall on atorvastatin but it's not the first time the Indian company has been in trouble with domestic regulators. Ranbaxy is one of the leading producers of generic prescription medications but in 2008 was ordered to stop shipping 30 drugs to the U.S. due to "systemic" failures at the company, the FDA said, which inhibited it from manufacturing drugs that could be considered safe to patients to take without risking serious injuries or death.

According to an update on the legal proceedings regarding Yaz and Yasmin injuries, Bayer states that it has paid at least $750 million in settling 3,490 lawsuits filed by or on behalf of women who suffered deep vein thrombosis or pulmonary embolism while taking the relatively new contraceptive drugs. The company still faces another 3,800 lawsuits which also make those injury claims and those closest to the proceedings believe the pharmaceutical giant will likely spend that much or more to settle those claims.

Many of these lawsuits have been consolidated for pre-trial proceedings as part of a federal Multidistrict Litigation. The MDL process expedites and streamlines pre-trial motions and decisions. This process aims to avoid appeals due to inconsistent rulings.

In addition to that, Bayer still faces another 5,000 personal injury lawsuits filed by or on behalf of women who claim Yaz or Yasmin caused them to suffer other serious injuries to their gallbladder or even sudden death. That means Bayer could spend into the billions of dollars settling claims or through jury awards to victims of the dangerous side effects of these oral contraceptives. 

Bayer has faced more than 12,000 lawsuits already related to injuries caused or believed to be caused by Yaz or Yasmin. And the estimates on legal costs to date and in the future only account for the lawsuits already filed. More lawsuits filed against Bayer over Yaz and Yasmin injuries are filed daily and despite the now-known risks the drugs pose to women taking them, prescriptions continue to be written.

The drug company has faced more than legal action since it launched Yaz and Yasmin. The company has been subjected to federal fines over its illegal marketing of the contraceptives, including the use of Web ads that completely ignored mentioning the drug's side effects. The company has also faced charges that it hid data showing that women who took Yaz or Yasmin faced a greater risk of deep vein thrombosis or pulmonary embolism than women taking another form of contraceptive.

Bayer launched Yaz and Yasmin in 2006 and since that date, it has been subject to widespread speculation despite heavy marketing campaigns that touted the benefits of the drug, including the ease in taking the drug over traditional contraceptives. 

This lack of current knowledge regarding the safe and effective use of IUDs turns into misinformation relayed to women who are considering a device like Mirena as their form of birth control. This could put some at risk of serious side effects or it could be steering women away from the devices when no evidence of risk is known. New research from Bixby Center for Global Reproductive Health at the University of California, San Francisco, shows that as many as half the physicians in the U.S. may be misguided or misinformed about the use of IUDs. 

Much of this information may be coming from the makers of Mirena IUD, Bayer Inc. Reports in the past have suggested that Bayer created an online social networking group to market Mirena. Ads for pharmaceuticals placed online are not fully regulated by the Food and Drug Administration but when these ads are found to overlook or ignore the side effects of drugs, the agency has stepped in in the past. 

This social group was hosted through the site, Mom Central, and the compay arranged impromptu "Mirena Parties" where women would discuss the benefits of using a Mirena devices. Bayer marketed Mirena for "busy moms" as the devices are generally only used by women who've already had one child.

In the recent study, which included data compiled during a widespread health survey and done in two periods (once in 2010 and again this year), showed that as many as half the doctors interviewed said they believed IUDs were not safe for women who had just had a child. Thirty percent of doctors said they believed IUDs like Mirena were not safe for women who had just had an abortion.

These beliefs go against clinical data that suggests otherwise, that Mirena and other IUDs were safe and effective for each of those groups of women, but it shows that doctors may not be up-to-date on the latest information available on these devices. That includes knowing of the dangers these devices pose, despite the studies that say they're safe and effective. 

Mirena and IUDs are implanted in the uterus and designed to prevent pregnancy. One device can be implanted for up to five years. During that time, many women have suffered serious and some life-threatening side effects as a result of the dangerous devices. Previous research has linked IUDs like Mirena to uterine perforation, miscarriage, infertility or at least increasing the risk of infertility, intrauterine pregnancy, pelvic inflammatory disease, and several other serious concerns. 

Some devices, according to an NBCNews.com report on the new study, have been linked to problems like heavy bleeding, cramping, and inflammation. The study used by researchers at Bixby Center for Global Reproductive Health was gleaned from surveys taken of more than 250 doctors, nurses, midwives, and doctor's assistants in Colorado and Iowa.

Parker Waichman LLP is a leading personal injury law firm with experienced defective drug attorneys on staff. We are currently one of the leading law firms dealing with pharmaceutical litigation cases and are evaluating cases involving defective drug lawsuits throughout the United States.

Prescription drugs with deadly or dangerous side effects are often rushed to market without adequate testing and often people are injured or die before they are identified by the FDA as having dangerous side effects that outweigh whatever benefits they may have.

When an FDA classification leads to a drug recall and when an injury occurs, a lawsuit is filed and is based upon personal injury law. Drug recall lawsuits will usually fall into such categories as drug injury law, product liability or medical malpractice lawsuits against drug companies

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