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FDA News

http://www.fda.gov:80/bbs/topics/NEWS/2008/NEW01786.html

FOR IMMEDIATE RELEASE

January 31, 2008

Media Inquiries:

Sandy Walsh, 301-827-6242

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888-INFO-FDA

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.