New Warning Labels for Epilepsy Drugs Coming Soon
Posted by aranya | Filed under Uncategorized
The FDA is preparing to put warning labels on epilepsy drugs that will notify users about the increased risk for suicidal behavior.
“Everything points in the direction of an increase in what we call suicidality,” said Dr. Russell Katz, director of the FDA’s neuropharmacological drug division in a Katz said in a June 6 Wall Street Journal article.
In January, the FDA announced that a review of 199 studies comparing 11 epilepsy drugs to placebos found that patients taking the drugs had about twice the risk of suicidal behavior compared with patients taking a placebo. Almost 44,000 patients in the studies, four people taking antiepileptic drugs committed suicide while none of the patients receiving a placebo did.
The drugs in this study 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) and Zonisamide (marketed as Zonegran). Some of these drugs are also available as generics.
Some epilepsy drug makers like Pfizer and Abbot Laboratories have contested the FDA’s decision to place warning labels on the drugs claiming that the risks for suicidal behavior are minimal and that the labels will negatively impact company revenues.
I personally find this to be pretty galling, since pharmaceutical companies are basically saying they don’t want the FDA warning labels on their drugs because it means they will make less money. Translation: the fact that our drugs might cause people to kill themselves is less important than the fact that we might not make as much money as we want.
August 17th, 2008 at 5:53 am
It is really sad when seeing the thing that concerns these companies is not the fact that their drug may cause the death of people but the fact that warning about it may cost them money. Where has the dignity in this field gone?