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FDA Investigating Migraine Patch Skin Reactions

👤by WebMD 0 comments 🕔Monday, June 6th, 2016

By Megan Brooks

June 3, 2016 -- The FDA is looking into the risk for serious burns and potential permanent scarring from a patch used to treat migraines, the agency said in a statement Thursday.

The sumatriptan iontophoretic transdermal patch is called Zecuity.

It's meant for a single use and is battery-powered. It can relieve migraine headache pain and the nausea that sometimes comes with it. Zecuity was approved in 2013 to treat migraines with or without aura in adults. It uses an electrical current to deliver the drug sumatriptan through the skin.

According to the FDA, since the product came on the market in September 2015, a "large number" of people have said they got burns or scars on the skin where they wore the patch. The reports include severe redness, pain, skin discoloration, blistering, and cracked skin.

"As a result, we are investigating these serious adverse events to determine whether future regulatory action is needed," the agency said. It didn't specify how many people had reported these problems.

While the investigation is going on, people who have pain where they apply the patch should remove it immediately, the FDA said. If you get migraines, you can use a different form of sumatriptan or switch to another medicine.

The FDA urges patients and doctors to report possible side effects involving the Zecuity patch to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online, or by mail.

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SOURCE: Medscape: "FDA Investigates Skin Reactions with Zecuity Sumatriptan Patch."

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