Provigil Needs Stronger Warning against Use In Children, FDA Panel Says

<"">Provigil, a drug used to treat excessive sleepiness, should bear a stronger warning on its label that the medication is not approved for use in children under the age of 16, a Food & Drug Administration (FDA) panel said yesterday.  While Provigil, manufactured by Cephalon, is not approved for use in children, it has been prescribed to treat a variety of conditions in kids quite frequently.

Approved by the FDA in 1998, Provigil has been used to treat the excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. However, it is known that doctors also prescribe Provigil for a number of off-label uses in both adults and children.  In many cases, Provigil is used in the treatment of Attention Deficit Hyperactivity Disorder, Multiple Sclerosis and depression. It is estimated that as much as 90% of all Provigil prescriptions are written for off-label use. Such off-label use is not illegal, as doctors are free to prescribed approved drugs in any way they see fit. However, drug companies are not allowed to market a medication based on off-label use. In 2004, Cephalon was investigated for allegedly promoting off-label uses for Provigil.

While the current label does note that Provigil has not been approved for children under 16, several FDA advisory 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 FDA advisors voted 12-0 that more forceful language stating that Provigil is not recommended for use in children is necessary.

In October, the FDA updated the Provigil label to warn of several dangerous side-effects associated with its use.  That updated Provigil label says that the drug has been associated with a number of serious skin disorders, including Stevens-Johnson Syndrome, a sometimes life-threatening hypersensitivity complex affecting the skin and the mucous membrane. Provigil has also been linked to Toxic Epidermal Necrolysis, another life-threatening, and usually drug-induced, dermatological condition that is characterized by the detachment of the top layer of skin from the lower layers of the skin all over the body. Other conditions linked to Provigil include Drug Rash with Eosinophilia and Systemic Symptoms, a severe, unexpected reaction to a drug, which affects several organ systems at the same time; and Angioedema, a swelling beneath the skin similar to hives.  Patients are warned to stop using Provigil at the first sign of a skin rash and contact their doctors immediately. Patients who experience any swelling of the face, eyes, lips, tongue, larynx or experience difficulty swallowing or breathing, or suffer from hoarseness should also stop using Provigil.

In addition to the skin disorders, the FDA has warned that Provigil use has been connected to severe psychiatric symptoms, including anxiety, mania, hallucinations, and suicidal thoughts. The new Provigil labeling cautions physicians against prescribing the drug to people with a history of mania or depression, and says that Provigil use should be halted if a patient develops any psychiatric symptoms.

The FDA is not obligated to follow the recommendations of advisory panels, but it most cases the agency does.

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