The FDA is requiring a new warning label for the methylphenidate transdermal system, or Daytrana, which treats attention deficit-hyperactivity disorder in children aged 6 to 17. Dozens of those using the patch have reported depigmentation or hypopigmentation of the skin in areas as large as 8 inches in diameter. The symptom, which appears two to four months after beginning treatment, is not physically harmful but difficult to reverse.
Shire obtained FDA approval to market its Daytrana skin patch to treat patients ages 13 to 17 with attention-deficit/hyperactivity disorder. The treatment, which contains methylphenidate, previously was approved for those ages 6 to 12.
The FDA approved Shire's Intuniv, an extended-release drug for attention-deficit/hyperactivity disorder in children ages 6 to 17. The British company said the drug, the first selective alpha-2A receptor agonist for ADHD, is expected to be available at U.S. pharmacies in November.
The FDA has approved Shire's Intuniv, an extended-release ADHD drug for children ages 6 to 17. The British company said the drug, the first selective alpha-2A receptor agonist for ADHD, is expected to be available at U.S. pharmacies in November.
An FDA adviser says the recently approved patch for treating children with attention deficit hyperactivity disorder should not be the first choice of treatment. Daytrana, made by U.K.-based Shire PLC, could cause side effects if users leave the patch in place longer than the recommended nine hours, said Richard P. Malone, a member of the advisory panel that recommended approval of the patch.