The Food and Drug Administration (FDA) has identified another drug that could have especially dangerous side effects in children – Provigil, approved to treat sleep disorders. Experts want a stronger warning placed on the drug’s label expressly stating that it is not approved for use in pediatric patients.
Provigil’s Frazer, Pennsylvania-based manufacturer, Cephalon, has sent out a letter to doctors reminding them that the drug is not appropriate for use in children. The label was recently updated with risks including serious skin rashes, hallucinations, anxiety, and suicidal thoughts. The label change failed to mention that Provigil should not be given to kids.
Provigil is sometimes prescribed off-label to children with attention deficit hyperactivity disorder. Concerned with this use of the drug, FDA experts hope that the proposed label change will send a strong signal out to healthcare professionals by warning about Provigil’s potential dangers for children.