Federal regulators are considering new suicide warnings for some epilepsy drugs, but the pharmaceutical companies that make the medications are desperately trying to quash the action, The Wall Street Journal reported today. The drug makers, including GlaxoSmithKline and Pfizer, Inc., made their case to the Food & Drug Administration (FDA) at a closed meeting on Monday. How successful the industry was may become apparent next month, when the FDA holds a public meeting to discuss possible warnings for epilepsy drugs.
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 FDA 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. In January, the findings prompted the FDA to issue an early communication warning about the drugs’ potential for suicidal thoughts and behavior.
An FDA advisory panel is slated to take up the issue of epilepsy drugs and suicide in July, and it is very possible the panel will recommend new warnings be added to the labels of the epilepsy drugs. But the makers of these drugs want to avoid this. According to The Wall Street Journal, several companies at Monday’s forum held by the Epilepsy Study Consortium expressed concern to the FDA that its analysis is flawed. Three firms, including Pfizer and Glaxo, made presentations at the meeting.
Pfizer, in particular, has good reason to want to prevent new warnings on the drugs. Pfizer is counting on one of the drugs on the FDA list, Lyrica, to be a huge growth driver for the company. Lyrica was recently approved to treat fibromyalgia in addition to epilepsy, and racked up $1.8 billion in sales last year. Pfizer is especially desperate to protect Lyrica, since its once-promising anti-smoking drug Chantix, got a suicide warning earlier this year.
Following Monday’s meeting, some drug company executives told The Wall Street Journal that they expected the FDA would go ahead with new suicide warnings for epilepsy drugs, despite their protestations. Consumers will have to wait until at least July to see how this will all play out.