12 July, 2008 17:33 GMT
An advisory panel to the US
Food and Drug Administration has concluded that the agency's strongest warning -- a black box on the label -- would not be in the best interests of patients taking 11 drugs prescribed for epilepsy and other health problems such as bipolar disorder and migraines. Although studies show the drugs are linked with higher incidences of suicidal thoughts, that side effect is relatively rare, the panel noted, and the risk that patients might be afraid to take drugs they need is too great.
The drugs in question are carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR), felamate (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).
The FDA typically, but not always, follows the recommendations of its advisory panels. In this case, the agency is expected at least to require the inclusion of cautionary language in instructions for taking the medication advising caregivers to be alert to changes in mood or behavior.
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