FDA Panel Urges Provigil Warning

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.

However, Provigil, a stimulant drug, is sometimes used off label for use in treating attention deficit hyperactivity disorder in children. Several panel members said they were concerned about that off-label use and wanted to send a stronger signal that the drug shouldn't be used in children.

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 typically follows its panel's advice but is not required to do so.