This past Wednesday, an FDA advisory panel recommended that Provigil, Cephalon's most popular drug which brought in close to $415 million in the first half of 2007, have stricter warning labels for children.
Provigil is used to treat narcolepsy, but has not been approved to treat narcolepsy in children, or to treat attention deficit disorder- one of its many unapproved uses according to the FDA panel. Provigil also, in some cases, can cause Stevens-Johnson syndrome, whose symptoms include a severe rash.
Considering that the FDA almost always takes the advice of its advisory panel, it is safe to say that we can expect a stricter warning for children on Provigil labels.
If you have a child who takes Provigil for narcolepsy or attention defecit disorder, contact your doctor to make sure the benefits of this medicine for your child outweighs the potential harm it can do to those 16 and under.
To read the full Reuter's article on the FDA panel's suggestions, go here.
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