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New Epilepsy Warnings Sought By FDA


July 10th, 2008 · No Comments

National Agency Seeks Label Change For 11 Medications.Washington, D.C.- There are warnings that are featured on the packages of epilepsy medications at the current time, but the federal supervising agency overseeing them wants to seriously strengthen the type and intensity of the warnings.

The Food and Drug Administration is going to soon seek to strengthen warnings on 11 different epilepsy drugs according to documents on the FDA Web Site.

The FDA believes there is evidence of strong concern regarding risks of suicide for patients that take the different 11 medications.

Some of the drugs already have reasonably strong black box warnings, as well as warnings regarding the danger of different suicide risks.

The FDA agency stated in June that they were expecting to finalize language warnings regarding suicidal thoughts and other dangers to patients who are taking epilepsy medications.

The new round of mandatory labeling changes are likely to affect the large drug manufacturers the most. Pfizer is the company that is likely to be affected the most.

Pfizer markets the leading drug Lyrica which is new to the market but it brought in $1.8 billion dollars in revenue for the company.

Tags: Health