Wednesday, April 05, 2006
Is Provigil Good For ADHD?
According to the panel of experts that advises the FDA, Provigil, a drug used to treat ADHD, is not safe enough to win their approval. They are most concerned about the side effects of skin rashes, which can lead to hospitalization. They have called upon the manufacturer, Cephalon, to conduct more clinical trials, believing more patients need to be studied before approval will be granted. They voted 12-1 against recommending Provigil as safe for children who have ADHD. Provigil, already approved to treat sleep disorders, is seeking to market under the name Sparlon for those with ADHD. This ADHD version, also known as modafinil, would be a smaller tablet and have a wider range of doses. Although approval was given by the FDA in October of 2005 to use for ADHD, it had concerns about rashes, mania, aggression and other possible psychiatric effects that prompted the added advice from the expert panel. Even if the wider use is approved, Sparlon will more than likely come with the strongest warning possible, which is the black box warning. This recommendation follows only one day after another FDA panel called for all ADD drugs to include new information about psychiatric and heart risks, even though the data is still unclear. Apparently some panel members are uneasy about supporting Sparlon when other treatments are available and just as effective. This is another setback for Cephalon, who faced problems with its sleep disorder drug Nuvigil and the Vivitrol alcoholism treatment it is developing along with Alkermes Inc. The FDA committee recommends that Cephalon carries out a trial of 3,000 patients to help determine the risk the drug may pose for the sometimes fatal skin disease known as Stevens-Johnson Syndrome, which can produce widespread blistering and rashes. During previous studies, it was found that one out of 900 children developed the disease.