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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.

Epilepsy Drugs Linked to Suicide

Fri, 01 Feb 2008 00:00:00 -0800

Epilepsy drugs, including Pfizer Inc.'s Neurontin, Novartis AG's Tegretol and Abbott Laboratories' Depakote, have been linked to an increased risk of suicidal thoughts and behavior, the Food & Drug Administration (FDA) warned yesterday. According to an FDA analysis, people taking epilepsy drugs are twice as likely to experience suicidal thoughts or behavior as those taking placebo.

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.

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 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.

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, including 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 epilepsy 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.

Epilepsy Drug Can Increase Risk for Newborns, Study Says

Fri, 04 May 2007 00:00:00 -0700

Doctors reported yesterday that expectant mothers with epilepsy who took a commonly prescribed drug to control seizures were at increased risk of having a child with mental deficits.

Toddlers who had been exposed in the womb to the drug Depakote, from Abbott Laboratories, scored seven to eight points lower on I.Q. tests at age 2 than those whose mothers had been taking other epilepsy drugs while pregnant, the study found. They were twice as likely to score in the range associated with mental retardation, according to the authors, who presented the findings at the annual meeting of the American Academy of Neurology in Boston.

Other researchers said the findings should be considered preliminary because I.Q. measures were less reliable in 2-year-olds than in older children; the study will continue, tracking children through age 6.

The report is consistent with several recent studies finding that Depakote is more likely than other so-called anticonvulsant drugs to increase the risk of mental deficits and other birth defects, like neural tube problems. An estimated 24 million American women have taken these drugs which include Tegretol from Novartis, Lamictal from GlaxoSmithKline and Dilantin from Parke Davis for an array of problems, including epilepsy, bipolar disorder and migraine headaches, according to an analysis by the Epilepsy Foundation.

“Depakote looks worse than the other drugs in all of these recent studies,” said Dr. Kimford J. Meador, a professor of neurology at the University of Florida and the lead author of the new study. “In all, it is compelling evidence that this drug should not be used as a first-line choice for treatment in pregnant women.”

Laureen Cassidy, a spokeswoman for Abbott, said that for many women, “Depakote may be the only effective seizure control medication, and that decision should be made thoughtfully between physician and patient to fully evaluate the risk vs. benefit of treatment.”

The drug’s label now states that Depakote “has been associated with birth defects in children of women who have taken it while pregnant.”

Untreated seizures can endanger the life of a fetus and the expectant mother. And some 90 percent of women with epilepsy give birth to healthy, developmentally normal children even though many are taking medication, experts say.

The researchers followed 185 children through age 2, using standard I.Q. measures. The mothers in the study, while pregnant, took either Depakote, Lamictal, Tegretol or Dilantin. After controlling for the mothers’ I.Q. scores, the researchers found that 2-year-olds exposed to Depakote scored significantly lower on standard intelligence measures than the others.

“It’s fair to say that there has been concern about these drugs, and particularly Depakote, for the past two or three years, but we’ll know the complete story about its effect on cognitive development when we look at older children,” said Dr. Lewis Holmes, a professor of pediatrics at Harvard Medical School.

Depakote Birth Defects Injury Lawyer

Fri, 04 May 2007 00:00:00 -0700

Depakote Has Been Linked to Birth Defects

Depakote (generic: divalproex) is used to treat certain types of seizures and convulsions. It can be prescribed alone or with other epilepsy medications. Depakote is manufactured by Abbott Laboratories and gained FDA approval in 2000. On May 3, 2007, doctors reported that expectant mothers with epilepsy who took Depakote to control seizures were at increased risk of having a child with mental deficits.

Toddlers who had been exposed in the womb to Depakote, scored seven to eight points lower on I.Q. tests at age 2 than those whose mothers had been taking other epilepsy drugs while pregnant, the study discovered. They were twice as likely to score in the range associated with mental retardation, according to the authors, who presented the findings at the annual meeting of the American Academy of Neurology in Boston. The report is consistent with several new studies finding that Depakote is more likely than other so-called anticonvulsant drugs to increase the risk of mental deficits and other birth defects, like neural tube problems.

“Depakote looks worse than the other drugs in all of these recent studies,” said Dr. Kimford J. Meador, a professor of neurology at the University of Florida and the lead author of the new study. “In all, it is compelling evidence that this drug should not be used as a first-line choice for treatment in pregnant women.” The drug’s label currently states that Depakote “has been associated with birth defects in children of women who have taken it while pregnant.”

If you or a loved one took Depakote while pregnant and gave birth to a child with mental deficits, you may be entitled to compensation. Please fill out the form at the right for a free case evaluation by a qualified defective drugs attorney. Alternatively, call 1-800-LAW-INFO (1-800-529-4636).