On Wednesday the an FDA panel suggested that Cephalon’s sleep disorder drug, Provigil, should care a stricter warning urging doctors not to prescribe the drug to children. The drug is approved to treat various sleep disorders in adults; however, doctors have been frequently prescribing the drug to treat the same disorders in children. The FDA is concerned that this could have serious adverse effects for children.
Provigil recently received an updated label by the FDA to warn of serious skin reactions and psychological problems. Patients have reported episodes of hallucination, anxiety, and even suicidal ideation. These types of effects can be very serious for anyone, especially children.
Many physicians also prescribe Provigil to treat attention deficit hyperactivity disorder, ADHD. Provigil is not approved for this treatment of ADHD but off-label prescription has become commonplace in today’s world.
The 12-member panel unanimously said language stating the drug is not recommended for use in children is needed in addition to the language that states the drug is not approved for use in pediatric patients.
The FDA is not required to follow the advice of these panels but often does.
For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.
The Legal Examiner and our Affiliate Network strive to be the place you look to for news, context, and more, wherever your life intersects with the law.