The Food and Drug Administration is evaluating patient reports of serious burns and potential permanent scarring that have occurred with the use of the Zecuity patch (sumatriptan iontophoretic transdermal system) to relieve migraine headaches.

Since September 2015, a large number of patients using the Zecuity patch have reported that they have experienced burns or scars on the skin where the patch was worn. Severe redness, pain, skin discoloration, blistering, and cracked skin were reported, according to the agency’s June 2 drug safety announcement .

The Zecuity patch contains sumatriptan which is a prescription medicine used to treat acute migraine headaches in adults. It is designed to give a dose of medicine by way of a single-use, battery-powered patch that is wrapped around the upper arm or thigh.

“Health care professionals should advise patients who complain of moderate to severe pain at the application site to remove the Zecuity patch immediately,” the safety report states. “Consider a different formulation of sumatriptan or switch these patients to an alternative migraine medicine.”

It is advised that patients should not bathe, shower, or swim while wearing the patch. Patients and health care professionals should report possible side effects involving the Zecuity patch to the FDA MedWatch program .

llaubach@frontlinemedcom.com

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