Welcome to FDA Drug Safety Podcasts for health care professionals. This is Lesley Navin, Advanced Practice Nurse from the Division of Drug Information.
On June 2, 2016, FDA announced it is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. We are investigating the cause and extent of these serious side effects and will update the public with new information when our review is complete.
Patients should not bathe, shower, or swim while wearing the patch. Health care professionals should advise patients who complain of moderate to severe pain at the application site to remove the patch immediately. Consider a different formulation of sumatriptan or switch patients to an alternative medicine. Evaluate patients and application site as needed.
The Zecuity patch is designed to deliver a dose of medicine by way of a single-use, battery-powered patch wrapped around the upper arm or thigh. It should remain in place for no longer than four hours.
Since marketing began in September 2015, a large number of patients have reported experiencing burns or scars on the skin where the patch was worn. Reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. We are investigating to determine whether future regulatory action is needed.
Side effects involving the Zecuity patch should be reported to FDA’s MedWatch program at www.fda.gov/medwatch. A link to the full communication can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at firstname.lastname@example.org.
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