Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) announced that it has approved updated labeling for antieplieptic drugs used in the treatment of epilepsy, psychiatric disorders and other conditions including migraine and neuropathic pain syndromes, to include warning in the labeling of the risks of suicidal thoughts or actions.

The labeling follows an FDA analysis of reports of suicidality (suicidal behavior or ideation) from controlled clinical trials of drugs used to treat the above mentioned conditions, which indicated a relative risk for suicidality was higher in patients with epilepsy compared to patients who were given the drugs in the class for psychiatric or other conditions.

The FDA is advising health care professionals to closely monitor all patients currently taking or starting any antiepileptic drug for noticeable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The analyses included the brand name or generic versions of the following medications:

• 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)

While the above mentioned drugs are the only ones included in the analysis, the FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.

Source: FDA

This entry was posted on Thursday, May 7th, 2009 at 7:00 am and is filed under product liability. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.