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Epilepsy Drugs May Get New Suicide Warnings, In Spite of Pressure From Big Pharma


Federal regulators are considering new suicide warnings for someepilepsy 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.

TheFDA 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.

.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.







  Autoimmune Hepatitis