Wednesday, July 9, 2008

FDA Urging Black Box Warning For Epilepsy Drugs

WASHINGTON (Reuters) - Food and Drug Administration officials are pushing for a "black box" warning about the risk of suicidal thoughts and behavior with epilepsy drugs, just days ahead of a public meeting on the issue.

"We are going to ask for a boxed warning on these drugs," FDA spokeswoman Sandy Walsh said on Monday. The warning would apply to all epilepsy drugs, even those that showed no risk signal, according to an agency memo that was also released.

The FDA will ask an advisory panel on Thursday to weigh the proposed boxed warning -- the strongest type the agency can seek. The panel of outside experts is set to discuss risks with drugs to treat the disease, which is marked by seizures that can cause involuntary movement or behavior.

Last month, an FDA analysis concluded the medicines are associated with a higher risk of suicidal thoughts and behavior. That echoed findings from other other data released by the agency earlier this year. FDA's Walsh said the agency is proposing the black-box warning based on that data, but will seek the panel's input.

July 7, 2008 Monday

Source :

"We are what we eat. What goes into our body is reflected in our state of mind and health. Consumers should always be made aware of the pros and cons of the drugs they are on", says Serene

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