The U.S. Food & Drug Administration (FDA) is warning that the Zecuity migraine headache patch (sumatriptan iontophoretic transdermal system) may cause severe burns that can lead to permanent scarring.



Update: Teva Pulls Zecuity Migraine Patch Off Market After Reports of Burns, Scars

June 10, 2016 – Teva Pharmaceuticals is temporarily suspending sales, marketing and distribution of the Zecuity migraine patch to investigate the cause of burns and scars associated with the device, according to an FDA Drug Safety Communication issued today.

“Although many cases resolved within hours to weeks, there are reports of cases with unresolved skin reactions, typically skin discoloration, after several months,” Teva says in a letter to healthcare providers (PDF). The company says it’s working with the FDA to examine adverse skin reactions connected to using Zecuity.

What’s the Problem?

June 2, 2016 – FDA said it was investigating complaints about the Zecuity patch, which delivers the migraine drug sumatriptan through the skin using a battery-powered electric current. Some patients have reported experiencing blistering reactions and burns after using the device, according to the agency.

“A large number of patients have reported they experienced burns or scars on the skin where the patch was worn,” FDA said. “The reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. 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 who experience pain at the Zecuity application site should take the device off immediately to avoid burns or scarring, regardless of how long it has been in use. The patch should never be worn while bathing, showering or swimming, according to the FDA.

Zecuity was approved in September 2015, and can be wrapped around the arm or thigh. It’s a one-time use product and users are supposed to take it off after 4 hours.

Over 36 million American suffer from migraines, according to the American Headache Society (AHS). Of these, about 4 million have chronic migraine and suffer headaches 10 to 14 days per month.

Migraines are not ordinary headaches and while some people are helped by over-the-counter (OTC) medications like ibuprofen, others require stronger prescription drugs such as sumatriptan and ergotamine, which work by constricting blood vessels in the brain.

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