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Feb 1
Epilepsy Drugs To Get FDA Warning

The U.S. Food and Drug Administration issued an alert yesterday that epilepsy drug could increase the risk of suicidal thought of behaviour.

The alert comes as a result of the FDA having reviewed almost 200 studies of 11 anti-seizure drugs that have been sold for decades. 28,000 people had been fEpilepsy.jpgollowed in the studies who had been given the medications and 16,000 that had been given placebos. While the side effect of suicidal thoughts or behaviours were rarely reported the FDA did find that those taking the epilepsy drugs had twice the risk over those taking the placebo. 0.43 percent as compared to 0.22 percent.

Even though anti-seizure drugs are used in other illnesses such as migraines, nerve-pain disorders and psychiatric illnesses the FDA still found that those being treated for epilepsy still had a higher risk.

The 11 drugs tested included:

The FDA stated that it would work with the manufacturers of epilepsy drugs to add a new warning to the drug's label.

"We want health care professionals to have the most up to date drug safety information," said Russell Katz, M.D., director of the Division of Neurology Products in FDA's Center for Drug Evaluation and Research. "This is an example of FDA working with drug manufacturers throughout products' lifecycles to keep health care professionals informed of new safety data."

[Source: FDA]

 

 

 


2 Comments/Trackbacks




» Topamax (topiramate) May Cause Birth Defects from PharmaGazette
Only one month after Johnson & Johnson was required to put a black box warning on Regranex and a week after the U.S. Food and Drug Administration rejected a black box warning on epilepsy drugs, research has found that J&J's Topama... [Read More]

» Epilepsy Drugs Likely to Avoid FDA Black Box Warning from PharmaGazette
In what was seen as a foregone conclusion in February 2008. a black box warning on epilepsy drugs is now far from reality.The U.S. Food and Drug Administration advisory panel agreed that the drugs may increase the risk of suicide... [Read More]

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