The U.S. Food & Drug Administration (FDA) is warning about a risk of serious burns and potential permanent scarring associated with use of the Zecuity migraine headache patch (sumatriptan iontophoretic transdermal system).
Update: Teva Suspends Sales of Zecuity Patch
June 10, 2016 - Teva Pharmaceuticals has temporarily suspended sales and distribution of the Zecuity migraine patch in order to investigate the cause of burns and scars linked to the device, according to the FDA. The company has asked health care professionals to stop prescribing Zecuity, and patients to stop using any remaining patches and contact their prescribers for information about alternative migraine drugs. Please refer to Teva's Dear Health Care Provider Letter (PDF) for more information.
FDA Warns of Burns and Scarring with Migraine Patch
June 2, 2016 - According to an FDA warning issued today, a large number of patients have reported suffering severe burns and/or permanent scars on their skin where the Zecuity patch was worn since it was approved in September 2015. Users of the device have complained of severe redness, pain, skin discoloration, blistering and cracked skin. As a result of these problems, the agency is investigating to determine whether future regulatory action is needed, and will update the public with new information when the review is complete.
What is Zecuity?
The Zecuity patch contains sumatriptan, a prescription drug used to treat acute migraine headaches in adults. The patch delivers sumatriptan via a single-use, battery-powered patch that is wrapped around the upper arm or thigh. Zecuity is designed to remain in place for no longer than 4 hours at a time.
Zecuity users who develop pain at the patch site should remove it immediately to avoid burns or scarring. FDA warns never to bathe, shower or swim while wearing the migraine patch. Read the Patient Information and Instructions for Use on the product’s labeling, and contact your doctor if you have additional questions or concerns.