Suicide Risk Warning for Fibromyalgia Drug - FDA Alert!

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FDA News

FOR IMMEDIATE RELEASE

January 31, 2008

Media Inquiries:

Sandy Walsh,

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FDA Alerts Health Care Providers to Risk of Suicidal Thoughts and

Behavior with Antiepileptic Medications

The U.S. Food and Drug Administration today issued new information

to health care professionals to alert them about an increased risk

of suicidal thoughts and behaviors (suicidality) in patients who

take drugs called antiepileptics to treat epilepsy, bipolar

disorder, migraine headaches, and other conditions.

An FDA analysis of suicidality reports from placebo-controlled

studies of 11 antiepileptic drugs shows that patients taking these

drugs have about twice the risk of suicidal thoughts and behaviors

(0.43 percent), compared with patients receiving placebo (0.22

percent). This risk corresponds to an estimated 2.1 per 1,000 more

patients in the drug treatment groups who experienced suicidality

than in the placebo groups.

" We want health care professionals to have the most up to date drug

safety information, " said Katz, M.D., director of the

Division of Neurology Products in FDA's Center for Drug Evaluation

and Research. " This is an example of FDA working with drug

manufacturers throughout products' lifecycles to keep health care

professionals informed of new safety data. "

Patients who are currently taking antiepileptic medicines should not

make any changes without first talking to their health care

provider. Health care providers should notify patients, their

families, and caregivers of the potential for an increase in the

risk of suicidal thoughts or behaviors so that patients may be

closely observed for notable changes in behavior.

Following a preliminary analysis of data from several antiepileptic

drugs that suggested an increased risk of suicidality, in March 2005

FDA requested this type of data from manufacturers of marketed

antiepileptic drugs for which there were adequately designed

controlled clinical trials. FDA received and reviewed data from 199

placebo-controlled studies of 11 drugs.

The analysis included 27,863 patients in drug treatment groups and

16,029 patients in placebo groups. There were four suicides among

patients in the drug treatment groups and none among patients in

placebo groups. There were 105 reports of suicidal thoughts or

behaviors in the drug-treated patients and 35 reports in placebo-

treated patients.

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.

Antiepileptic drugs in the analyses included the following:

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)

Some of these drugs are also available in generic form.

Although only the drugs listed above were part of the analysis, the

FDA expects that all medications in the antiepileptic class share

the increased risk of suicidality.

FDA will be working with manufacturers of marketed antiepileptic

drugs to include this new information in the labeling for these

products. The agency anticipates that labeling changes will be

applied broadly to the entire class of drugs. FDA is also planning

to discuss these data at an upcoming advisory committee meeting.

For more information

FDA Information for Healthcare Professionals: Suicidality and

Antiepileptic Drugs

www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm.