Teva Pharmaceuticals has decided to voluntarily suspend sales, marketing, and distribution of its sumatriptan patch (Zecuity) in order to investigate the root cause of adverse skin reactions associated with application of this product, said a US Food and Drug Administration (FDA) MedWatch alert released today.
The FDA announced June 2 that it is investigating the risk for serious burns and potential permanent scarring with the use of the product.
"Since marketing of the Zecuity patch began in September 2015, a large number of patients have reported they experienced burns or scars on the skin where the patch was worn," the MedWatch alert notes. "The reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. As a result, FDA is investigating these serious adverse events to determine whether future regulatory action is needed, and will update the public with new information when the FDA review is complete."
Healthcare professionals should discontinue prescribing Zecuity, which is indicated for the acute treatment of migraine with or without aura in adults, said the letter, signed by Denisa Hurtukova, MD, vice president, North American Medical Affairs, Teva Pharmaceuticals.
As well, patients should stop using any remaining patches and contact their prescribers for an alternative migraine medicine, said the letter.
Postmarketing reports of application site reactions have been described as severe redness, cracked skin, blistering or welts, and burns or scars where the patch is worn. Patients have described severe pain, itching, or burning.
Although most cases resolved within hours to weeks, cases of unresolved skin reactions, typically skin discoloration, after several months were reported, said the Teva letter.
Teva is working closely with the FDA to examine these reports, the company writes.
The Zecuity patch delivery system is designed to deliver sumatriptan by way of a single-use, battery-powered patch that is wrapped around the upper arm or thigh. It should remain in place for no longer than four hours, the FDA announcement said.
Healthcare providers and patients are encouraged to report adverse events to Teva at 1-800-896-5855 and to the FDA's MedWatch Adverse Events Reporting Program.
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Cite this: Zecuity Sumatriptan Patch Sales Suspended - Medscape - Jun 13, 2016.