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Drug Not Safe Enough To Treat ADHD Yet

Added March 30th, 2006

A Food and Drugs Administration advisory panel has stated that Provigil, a drug manufactured by Cephalon Inc., is not safe enough to be approved for the treatment of ADHD, even though trials have shown the drug to be effective.

The panel has recommended further testing for the drug in relation to its potential to treat ADHD. Panel members expressed concerns about one of the side effects of the drug, which was a rash that could lead to hospitalization of the patient.

A Florida University psychiatrist who is on the panel stated: "I think we're dealing with some fuzzy information. I don't want to do that experiment in the post-marketing arena." He stated that the drug needed further testing with more patients also being studied before approval was considered.

The drug is approved for the treatment of sleeping disorders, but the manufacturer of the medication also wants to get it approved for the treatment of ADHD in children and teenagers.

Drug Not Safe Enough... | Printable Version (Opens In New Window)

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