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Medication Safety Alerts

DaytranaR Patch (methylphenidate transdermal system)- MedWatch

06/24/2015

On June 24, 2015, the United States Food and Drug Administration (FDA) issued a warning that permanent loss of skin color may happen with use of the Daytrana® patch. This is not physically harmful, but it may be noticeable. The areas of skin color loss may range up to 8 inches in diameter and may not be reversible

A complete list of the affected products is provided here:

The FDA has provided the following information for plan members:

  • Permanent loss of skin color may happen with use of the Daytrana patch.
  • Members or their caregivers should monitor for signs of lighter areas of skin, especially around the areas where the drug patch has been placed, and report any changes in skin color to their doctors.
  • Patches of lighter skin may appear only in the areas where the patch has been applied, or it may appear on the body in places where the patch was never applied.
  • The skin condition is not physically harmful, but it may be noticeable and may not be reversible which can cause emotional distress.
  • Daytrana is a long-acting methylphenidate formulation that does not require the patient to swallow a pill.
  • Do not stop using the Daytrana patch without first discussing it with your doctor.
  • Discuss any questions or concerns about the Daytrana patch with your doctor.
  • Carefully read the patient Medication Guide that comes with the filled prescription.
  • Report any side effects from the Daytrana patch to your doctor and the FDA.

Do not stop using your medicine without talkingto your doctor. Your doctor is familiar with your medical history and can advise you on what to do with your medicine. If you need a prescription for a different medicine, please contact your doctor.

For more information, please call the FDA toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their Web site at www.fda.gov/Drugs.

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