FDA: Migraine Patch Could Cause Serious Burns and Scars

June 10, 2016 by Dr. Clemens Leave a Comment

Patients using the sumatriptan iontophoretic transdermal patch (Zecuity) to treat migraines could be burned or permanently scarred, warns the FDA. The agency says it has received a “large number” of reports of skin reactions associated with the patch since it went on the market in September 2015.

The patch — battery-powered and wrapped around the thigh or upper-arm — is meant to be used only once, for up to 4 hours. Reactions have included blistering, cracked skin, pain, redness, and skin discoloration.

Common side effects listed by the manufacturer include discomfort, itching, pain, redness where the patch is applied, and tingling. The manufacturer also warns of potential serious adverse events, including heart attack. (High-risk patients must get a heart exam prior to beginning treatment.)

The FDA will review the risk for serious skin reactions and may take further regulatory action. In the meantime, patients who experience pain at the application site should remove the patch and consult a healthcare provider.

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