Federal regulators want the makers of epilepsy drugs to add a black box warning to their labels about their association with suicidal thoughts and behavior. The Food & Drug Administration (FDA) is set to ask an outside advisory panel for its recommendations on the proposed black box at a meeting this Thursday.
In total, 11 epilepsy drugs could get the new black box warning - the FDA's strongest safety notice. They include:
* 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 began investigating if epilepsy drugs posed 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 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. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups. For every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo.
According to the FDA, three of the 11 drugs studied showed no clear signal of suicidal problems. However, the agency is still leaning towards including the warning on all the drugs, as sample sizes in some of the studies might have been too small to accurately assess suicide risks. One of the issues the agency will ask the panel to address at Thursday's meeting is whether all of the drugs, or just some of them, should be subjected to the black box.
The FDA is not bound to follow the recommendations of its advisory panels, but it usually does so.
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* Topiramate (marketed as Topamax)
* Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
My Husband tried the topomax once and for a migraine and I thought he was having a stroke. It was a new drug and it was free for trial uses. Bad stuff That was last year at this time.
This year he was sent to a Neurologist recommended by an ear throat and nose doctor. The neurologist could see by the Pscan that there were no cluster migraines but prescribed My husband Depakote just the same.
Depakote can cause the amonia levels in the liver to rise drastically and the sodium levels to decrease so badley that this drug can actually cause swelling on the brain. My husband and one other Nurse had taken this drug for migraines. The Nurse ws hospitolized. My husband had a knowledgeable doctor right there and ordered bloodwork. We had a pretty close call there by him only taking one of these pills. The bloodwork showed the high levels of amonia and the decreased levels of sodium.
A nuse told me that her daughter had also been given Depakote in the hopitol and her daughter started having seizures. I was told that the FDA will not take a drug off the market until 100,000 complaints have been documented. Thats alot of horror for alot of folks.A long time to wait and see also.