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Published on Nov 29, 2007 by Edgar Snyder

Sleep Drug Provigil May Hurt Kids

Provigil warning for kids

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.

Please note: All of our lawyers are licensed to practice in the state of Pennsylvania. We also have lawyers licensed to practice in Maryland, Ohio, Virginia, and West Virginia, and we associate with experienced attorneys in other states. In addition, all drug-related litigation may involve co-counsel.

Source: "Panel Seeks Warning to Prevent Pediatric Use of Sleep Drug." By Jennifer Corbett Dooren. Wall Street Journal. November 29, 2007.
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