Provigil Side Effects - More Warnings by the FDA
More warnings for the drug Provigil Side Effects by the FDA today.
A Food and Drug Administration panel said Wednesday that sleep disorder drug Provigil should carry a stronger warning to discourage doctors from prescribing it to children.
The drug by Cephalon Inc., which is approved to treat certain sleep disorders in adults, already contains labeling stating the product is not approved for use in pediatric patients.
The drug’s label was recently updated to warn of the possibility of serious skin reactions and psychological problems such as hallucinations, anxiety and suicidal thoughts. Cephalon sent doctors a letter detailing the change and noted the drug is not approved for use in children.
