FDA finalizing epilepsy black-box warnings

Stringent epilepsy drug black-box labeling is likely to worry consumers and drug manufacturers alike, and will bring the total of drugs with a suicide risk warning up to about 35.

The FDA made the decision to issue the warnings after analyzing data for nearly 200 trials of over 40,000 patients in a medication safety evaluation it initiated in 2005. They found that patients taking the epilepsy medications had almost double the risk of suicidal ideation or behavior compared to patients taking placebos. Additionally, while none of the individuals taking placebo medications committed suicide, four of those taking the epilepsy medications did.

All drugs come with warnings about possible side effects. But now, some drugs designed to treat conditions ranging from depression to the compulsion to smoke cigarettes carry warnings that tell patients that they could experience “suicidality,” the medical term for suicidal thoughts or behavior.

Source:Wall Street Journal

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