Yourlawyer.com (Lyrica News)

Pfizer Geodon Whistleblower Represented by Parker Waichman Alonso LLP

Wed, 09 Sep 2009 00:00:00 -0700

A whistleblower who was involved in last week's record breaking $2.3 billion Pfizer settlement was represented by the Great Neck, NY law firm of Parker Waichman Alonso LLP. The whistleblower lawsuit alleged that Pfizer illegally promoted the off-label use of the antipsychotic medication Geodon.

"We are proud of our client and the other relators who stepped forward to expose Pfizer's wrongdoing, and helped to make this settlement possible," said David Krangle, an attorney with Parker Waichman Alonso LLP. "We are also proud that our firm was able to play a part in obtaining justice for American taxpayers."

The Parker Waichman Alonso lawsuit was one of nine settled by the U.S. Department of Justice that charged Pfizer illegally marketed Geodon, as well as the pain killer Bextra; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug. The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs.

As we reported last week, the $2.3 billion settlement is the largest healthcare fraud settlement in the history of the U.S. Department of Justice. The Geodon portion of the settlement was $301 million.

Under the terms of the settlement, Pfizer subsidiary Pharmacia & Upjohn Company Inc. has also agreed to plead guilty to a felony violation that it illegally promoted the off-label use of Bextra. Pharmacia & Upjohn will pay $1.3 billion toward the total settlement.

Pfizer also has agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter, the Justice Department said.

Whistleblower lawsuits are filed under the False Claims Act, a federal law that empowers people to file lawsuits against federal contractors claiming fraud against the government. Successful whistleblowers can receive a portion of the damages recovered. According to the Department of Justice, the whistleblowers involved in last week's Pfizer settlement will receive $102 million of the federal fines.

Pfizer's Illegal Promotion of Bextra and Other Drugs Results in Record Settlement, Guilty Plea

Thu, 03 Sep 2009 00:00:00 -0700

Pfizer Inc. and its subsidiary, Pharmacia & Upjohn Company Inc., have agreed to pay a record-setting $2.3 billion to settle claims arising from the illegal marketing of some drugs. According to a U.S. Department of Justice press release, Pharmacia & Upjohn Company has also agreed to plead guilty to a felony violation regarding off-label promotions of the painkiller Bextra. Bextra was withdrawn from the market in 2005.

As we've reported previously, doctors may prescribe Food & Drug Administration-approved medicines any way they see fit. But companies are legally barred from promoting unapproved, or so-called off-label, uses.

According to the Justice Department press release, Pharmacia & Upjohn Company will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter, for the Bextra promotions. Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion. According to Reuters, Bextra had only been approved to treat two types of arthritis pain and uterine pain, but the government claims it was marketed as a treatment for all types of pain.

In addition, Pfizer has agreed to pay $1 billion to resolve allegations it illegally promoted Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug, causing false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs.

The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs. The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170. This is the largest civil fraud settlement in history against a pharmaceutical company, the press release said.

Pfizer also has agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter, the Justice Department said.

According to the Justice Department, the settlement is the result of the investigation instigated by six whistleblowers. As a result of the settlement, the whistleblowers will receive $102 million of the federal fines.

Baystate Medical Center Subpoenaed Over Fake Drug Studies

Wed, 08 Apr 2009 00:00:00 -0700

The Baystate Medical Center has received a subpoena as part of a federal investigation into a doctor there who falsified 21 drug studies. According to The Wall Street Journal, the U.S. Attorneys office in Boston is seeking financial records related to the work of Dr. Scott S. Reuben.

As we reported last month, medical journals have been asked to retract studies involving Vioxx, Celebrex, Lyrica and other drugs. All of the studies were published between 1996 and 2008. According to The Wall Street Journal, the journal Anesthesia & Analgesia has retracted 10 studies. It also posted a list of 11 others that were published in other journals on its Web site. The journal Anesthesiology said it has retracted three of Reuben’s articles.

These studies had a great deal of influence on the practice of medicine. Because of Reuben’s “research”, it had become routine for doctors to combine the use of painkillers like Celebrex and Lyrica for patients undergoing common procedures such as knee and hip replacements. Reuben even had the ear of the Food & Drug Administration, and had written the agency asking it not to restrict the use of many of the painkillers he studied. He often cited his fake data to make his case, the Journal said.

Many of the studies Reuben worked on involved drugs that have very serious side effects. Like many antidepressants, the labeling of Effexor warns that it has been linked to suicides in young people and children. Both Celebrex and Vioxx have been linked to heart attacks and strokes, and Vioxx was actually recalled in 2006 because of these problems.

Not surprisingly, Reuben has strong ties with the pharmaceutical industry. According to the Journal, he had been a paid speaker on behalf of Pfizer - the maker of Lyrica and Celebrex - and it paid for some of his research. Wyeth provided $10,000 in grant money to. Reuben from 2001 to 2003, the Journal said. Merck also funded some of Reuben's work.

According to The Wall Street Journal, Baystate Medical is cooperating fully with the federal government's probe of Reuben. A spokesperson for the Springfield, Mass., medical center told the Journal that Baystate isn't a target of the investigation.

Baystate Medical Center has placed Reuben on indefinite leave. He has also vacated an appointment as a professor at Tufts University’s medical school, the Journal said.

Researcher Faked Data for 21 Studies Involving Vioxx, Celebrex and Other Drugs

Wed, 11 Mar 2009 00:00:00 -0700

Medical journals have been asked to retract 21 studies that touted the benefits of Vioxx, Celebrex and other drugs. According to The Wall Street Journal, Baystate Medical Center, Springfield, Mass. is asking the journals to make the retractions because its former chief of acute pain, Dr. Scott S. Reuben, had faked data used in the studies.

In addition to Vioxx and Celebrex, some of the 21 studies involved the fibromyalgia drug Lyrica and the antidepressant Effexor XR. Reuben's study claimed to show that these drug worked well as painkillers, the Journal said. All of the studies were published between 1996 and 2008.

According to The Wall Street Journal, these studies had a great deal of influence on the practice of medicine. Because of Reuben's "research", it had become routine for doctors to combine the use of painkillers like Celebrex and Lyrica for patients undergoing common procedures such as knee and hip replacements, the Journal said.

Reuben even had the ear of the Food & Drug Administration (FDA), and had written the agency asking it not to restrict the use of many of the painkillers he studied. He often cited his fake data to make his case, the Journal said.

According to The Wall Street Journal, Reuben's fraud has caused the journal Anesthesia & Analgesia to retract 10 studies. It also posted a list of 11 others that were published in other journals on its Web site. The journal Anesthesiology said it has retracted three of Reuben's articles.

Not surprisingly, Reuben has strong ties with the pharmaceutical industry. According to the Journal, he had been a paid speaker on behalf of Pfizer - the maker of Lyrica and Celebrex - and it paid for some of his research.

Baystate Medical Center has placed Reuben on indefinite leave. He has also vacated an appointment as a professor at Tufts University's medical school, the Journal said.

Perhaps the most disturbing aspect of this scandal is that many of the drugs Reuben researched have been linked to serious side effects. Like many antidepressants, the labeling of Effexor warns that it has been linked to suicides in young people and children.

Both Celebrex and Vioxx have been linked to heart attacks and strokes, and Vioxx was actually recalled in 2006 because of these problems.

This is actually not the first time the integrity of studies involving Vioxx have come into question. Last April, we reported that an analysis of court documents uncovered in the course of Vioxx injury lawsuits found that Merck & Co. employees worked alone or with publishing companies to write Vioxx study manuscripts and later recruited academic medical experts to put their names as first authors on the studies. According to the analysis, which was published in the Journal of the American Medical Association, Merck’s involvement in producing the data wasn’t disclosed in many cases.

Lyrica, Cymbalta Fibromyalgia Promotions Questioned

Mon, 09 Feb 2009 00:00:00 -0800

Two drug makers are spending a fortune to promote medications for a disease that some doctors say may not even exist. According to the Associated Press, Eli Lilly and Pfizer have donated more than $6 million to nonprofit groups to spread information about fibromyalgia in an effort to boost sales of Cymbalta and Lyrica.

Fibromyalgia, defined as a chronic, widespread pain condition of unknown origin, is a controversial diagnosis. No biological tests exist to diagnose fibromyalgia, and the condition cannot be linked to any environmental or biological causes. While the Associated Press said that doctors agree that suffers' symptoms are real, they don't agree that a disorder called fibromyalgia is behind them. But real or not, there is obviously a huge market for fibromyalgia treatments.

Pfizer's Lyrica was the first prescription medication approved to treat fibromyalgia, though no one can explain exactly how it works. Lyrica was first approved to treat epilepsy. In 2004, the drug was reviewed by the Food & Drug Administration (FDA) as a remedy for diabetic nerve pain. According a New York Times report published last January, the reviewers recommended against approving the drug, citing its side effects. Lyrica causes weight gain and edema, or swelling, as well as dizziness and sleepiness.

But the FDA ignored the advice of Lyrica reviewers, and approved it anyway. Then Pfizer asked the FDA to expand the approved uses of Lyrica to include the treatment of fibromyalgia, and the agency did so in June 2007. According o the Times report, in clinical trials, patients taking Lyrica reported that their pain fell on average about 2 points on a 10-point scale, compared with 1 point for patients taking a placebo. About 30 percent of patients said their pain fell by at least half, compared with 15 percent taking placebos.

Pfizer’s success has encouraged other drug makers to seek approval for their own fibromyalgia drugs. Eli Lilly's antidepressant Cymbalta received such approval last June.

According to the Associated Press, both drug makers are spending big bucks to promote not only their drugs, but fibromyalgia as well. According to the report, key components of their marketing onslaught include more than $6 million in grants to nonprofit groups to pay for fibromyalgia medical conferences and educational campaigns. And that was only in the first three quarters of 2008, the Associated Press said. It's also more than the drug makers gave towards Alzheimer's Disease and diabetes, which are universally recognized as real diseases.

One doctor interviewed by the Associated Press called Eli Lilly's and Pfizer's fibromyalgia promotion efforts "disease mongering". That doctor, Frederick Wolfe, was lead author of the guidelines defining fibromyalgia in 1990, but now doubts the very existence of the disease.

Despite such concerns over the tactics used by Eli Lilly and Pfizer, they do seem to be working. According to the Associated Press, between the first quarter of 2007 and the fourth quarter of 2008, sales rose from $395 million to $702 million for Lyrica, and $442 million to $721 million for Cymbalta.

Epilepsy Drugs to Carry Suicide Warnings

Wed, 17 Dec 2008 00:00:00 -0800

Epilepsy drugs must now carry warnings about their suicide risks, the Food & Drug Administration (FDA) has announced. The drugs subject to the new warning include those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy. Epilepsy drugs on the list are:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER, Depakene)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal) Phenytoin (marketed as Dilantin Suspension)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Zonisamide (marketed as Zonegran)

Any available generic versions of these drugs will also carry the new epilepsy drugs, the FDA said.

The FDA said its actions were based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo, the agency said.

Four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The FDA added that the biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.

In addition to the suicide warning, the FDA is also requiring the drugs' manufacturers to submit f a Risk Evaluation and Mitigation Strategy for each medication , including a Medication Guide for patients. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed.

Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

Epilepsy Drugs Targeted for Black Box Suicide Warning

Tue, 08 Jul 2008 00:00:00 -0700

Federal regulators want the makers of epilepsy drugs to add a black box warning to their labels about their association with suicidal thoughts and behavior. The Food & Drug Administration (FDA) is set to ask an outside advisory panel for its recommendations on the proposed black box at a meeting this Thursday.

In total, 11 epilepsy drugs could get the new black box warning - the FDA's strongest safety notice. They include:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)

The FDA began investigating if epilepsy drugs posed any suicide risk in 2005. In doing so, the FDA analyzed almost 200 studies of 11 anti-seizure drugs, some that have been on the market for decades. The studies tracked almost 28,000 people given epilepsy medications and another 16,000 given dummy pills.

According to the FDA, 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers. The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups. For every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo.

According to the FDA, three of the 11 drugs studied showed no clear signal of suicidal problems. However, the agency is still leaning towards including the warning on all the drugs, as sample sizes in some of the studies might have been too small to accurately assess suicide risks. One of the issues the agency will ask the panel to address at Thursday's meeting is whether all of the drugs, or just some of them, should be subjected to the black box.

The FDA is not bound to follow the recommendations of its advisory panels, but it usually does so.

New Suicide Warning for Epilepsy Drugs

Thu, 12 Jun 2008 00:00:00 -0700

United States drug reviewers just announced that epilepsy drugs are associated with a higher risk of suicidal thoughts and behavior. The analysis was released this week and confirmed earlier findings. "The effect appears consistent among the group of 11 drugs" that were reviewed, according to a summary from statistical reviewers at the Food and Drug Administration (FDA). In the review dated May 23, the FDA staff said that there were about two more cases of suicidal thoughts and behavior per every 1,000 patients given the drugs versus those given a placebo. In January, the FDA released similar findings, according to FDA spokeswoman Sandy Walsh.

The epilepsy drugs include Pfizer Inc.'s Lyrica, GlaxoSmithKline's Lamictal, Johnson & Johnson's Topamax, and Abbott Laboratories Inc.'s Depakote. FDA officials said that they are working with the drug makers to add information about the suicidal behavior risk to the prescribing instructions for these drugs. Also, a panel of outside advisers to the FDA is scheduled to discuss the issue next month, on July 10.

The FDA staff reviewed 199 trials involving about 44,000 patients who were given either an epilepsy drug or a placebo. Some of the epilepsy medicines are also approved for depression, migraines, and other conditions. As a result, four patients given drug treatment committed suicide, compared with zero suicides in the group who received the placebo, according to the FDA staff review. Generally, approximately 0.4 percent of drug-treated patients reported suicidal thoughts or actions, compared with 0.2 percent of placebo patients.

In January, the FDA warned that all patients taking epilepsy drugs should be closely monitored for changes in behavior that could indicate either suicidal thoughts or behaviors or depression. Kara Russell, spokeswoman at Johnson & Johnson's Ortho-McNeil Neurologics Inc. unit—the group that makes Topamax—said the company was reviewing the FDA's report and confirmed that language about possible suicide behaviors or attempts "has existed in our labeling since the beginning." UCB SA spokeswoman, Andrea Levin, said prescribing instructions for its epilepsy drug, Keppra, already included data on suicidal behavior reported in clinical trials. Levin advised that UCB SA would comply if the FDA asked for changes.

A Glaxo analysis of Lamictal found a trend for suicidal thoughts and behavior that was similar to that found in the FDA analysis, according to company spokeswoman, Holly Russell. Glaxo is currently working with regulators to update the drug label, she said. Abbott spokeswoman Laureen Cassidy said the company would work with the FDA to implement any changes requested for the class of drugs.

Epilepsy is a neurological condition that, from time-to-time produces brief disturbances in normal electrical brain functions. When someone has epilepsy, normal electrical brain patterning may be interrupted by intermittent bursts of electrical energy that are much more intense than usual. These interruptions and bursts may affect a person's consciousness, bodily movements, or sensations for a short time and are called epileptic seizures and are why epilepsy is sometimes called a seizure disorder. The bursts may occur as partial seizures affecting just one area of the brain or can be generalized, affecting nerve cells throughout the brain.

Epilepsy Drugs to Get Suicide Warnings, FDA Confirms

Fri, 06 Jun 2008 00:00:00 -0700

US regulators are very close to finalizing new suicide warnings for 11 epilepsy drugs, The Wall Street Journal reported today. This past January, the Food & Drug Administration (FDA) issued an Early Communication announcing a safety review of the epilepsy drugs after a study showed they increased patients' risk of suicidal thoughts and behavior.

The 11 epilepsy drugs slated for a new suicide warning are:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)

In addition to treating epilepsy, the anti-seizure medications are used for a variety of other illnesses, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that themselves carry a risk of suicide.

According to the FDA, 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers. The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups. For every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo.

In an interview with The Wall Street Journal, Russell Katz, director the FDA's neuropharmacological drug division confirmed the suicide warnings are coming. "We are working on the labeling changes that we want to get to the companies," he said. An FDA advisory panel is slated to take up the issue of epilepsy drugs and suicide on July 10, but the Journal speculated the new warnings could come even sooner than that.

At least one drug maker, Pfizer Inc., is less than pleased at this development. Pfizer disputed the FDA's analysis in a forum this week sponsored by the Epilepsy Study Consortium in New York. Pfizer especially disputes the inclusion of Lyrica - one of the company's biggest growth drivers -on the FDA's warning list. Pfizer said that Lyrica accounted for only 6.3% of the total 142 suicidal events cited by the FDA analysis. But the FDA is sticking to its guns, and the new suicide warning will apply to all 11 epilepsy drugs.

Most other epilepsy drug makers are resigned to the label changes, according to the Journal. GlaxoSmithKline, the maker of Lamictal, approached the FDA this year to volunteer changes regarding possible suicidal-behavior risks. Other drug makers may have chosen not to challenge the FDA on suicide warnings because their medications are no longer as lucrative as they once were, as patents on many epilepsy drugs have, or are close to, expiring.

Epilepsy Drugs Double Suicide Risks, FDA Warns

Sat, 02 Feb 2008 00:00:00 -0800

Epilepsy drugs have been linked to a increased risk of suicidal thoughts and behavior, the Food & Drug Administration (FDA) warned this week. According to an FDA analysis, people taking antiepileptic drugs are twice as likely to experience suicidal thoughts or behavior than those taking placebo.

The FDA began investigating if epilepsy drugs pose any suicide risk in 2005. In doing so, the FDA analyzed almost 200 studies of 11 anti-seizure drugs, some that have been on the market for decades. The antiepileptic medications studied by the FDA included:

•   Carbamazepine(marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
•   Felbamate (marketed as Felbatol)
•   Gabapentin (marketed as Neurontin)
•   Lamotrigine (marketed as Lamictal)
•   Levetiracetam (marketed as Keppra)
•   Oxcarbazepine (marketed as Trileptal)
•   Pregabalin (marketed as Lyrica)
•   Tiagabine (marketed as Gabitril)
•   Topiramate (marketed as Topamax)
•   Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
•   Zonisamide (marketed as Zonegran)

The studies tracked almost 28,000 people given the medications and another 16,000 given dummy pills. According to the FDA, 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers. The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. There was no clear pattern of risk across age groups.

Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups. According to the FDA for every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo. Even though the FDA only looked at 11 epilepsy medications, the agency said the suicide warning applied to all epilepsy drugs.

Millions of people take epilepsy drugs. Such anti-seizure medications are used for a variety of illnesses in addition to epilepsy, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that themselves carry a risk of suicide.

Doctors and other healthcare providers where advised by the FDA to balance the risk for suicidal thoughts and behavior with the clinical need for the drug and to be aware of the possibility of the emergence or worsening of depression, suicidality, or any unusual changes in behavior. Healthcare providers where told to inform patients, their families, and caregivers of the potential for an increase in the risk of suicidality so they are aware and able to notify their healthcare provider of any unusual behavioral changes.

Because skipping epilepsy medication can result in seizures, the FDA said that patients should ask a doctor before making medication changes. The FDA said patients and their families should pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences. Patients and their families should be aware of common warning signs that might be a signal for risk of suicide, inlcuidng talking or thinking about wanting to hurt themselves or end their lives; withdrawing from friends and family; Becoming depressed or having depression get worse; becoming preoccupied with death and dying; and giving away prized possessions. If these or any new and worrisome behaviors occur, patients or their families should contact the responsible healthcare professional immediately.

The FDA said it would be working with manufacturers of marketed epilepsyc drugs to include this new information about suicide risks in the labeling for these products. The agency anticipates that labeling changes will be applied broadly to the entire class of drugs. The FDA is also planning to discuss the suicide data at an upcoming advisory committee meeting.

Lyrica Suicide Side Neurontin Effects Lawyer Lawsuit

Sat, 02 Feb 2008 00:00:00 -0800

Lyrica May Be Linked to Suicide

Keywords: Lyrica Suicide Side Effects Lawyer Lawsuit Neurontin

Lyrica & Neurontin Association
Lyrica (Generic: Pregabalin) is prescribed to patients for the management of neuropathic pain associated with diabetic peripheral neuropathy. Lyrica, manufactured by Pfizer, received FDA approval on December 30, 2004. Seizure patients also use Lyrica. Lyrica was manufactured as a substitute medication for Neurontin. Lyrica has only been tested and prescribed to adults 18 or older. Lyrica has not been studied in children under the age of 18. Lyrica, just like Neurontin, may cause increased risk of suicide and suicidal behavior.

Other Lyrica Side Effects
General side effects associated with Lyrica can include: dizziness, blurred vision, sleepiness, weight gain, swelling (edema), muscle problems, and altered perception. Weight gain is of particular concern to those with diabetes, as this can worsen their condition. Additional animal studies also found Lyrica to cause side effects in males. Lyrica lowered the fertility of some male animal subjects throughout testing. Males who received Lyrica who did reproduce had an increased risk of birth defects in their offspring.

Free Lawsuit Case Evaluation
If you or a loved one took Lyrica and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.