Less than two weeks after the Food and Drug Administration (FDA) announced it had launched an investigation into reports of burns and potential permanent scarring related to the Zecuity patch used to treat migraine headaches, the manufacturer, Teva Pharmaceuticals, announced it has decided to temporarily suspend sales, marketing and distribution to launch its own investigation into related safety risks.
The FDA is informing health care professionals to discontinue prescribing Zecuity, and informing patients to stop using any remaining patches and contact their prescribers for an alternative migraine medicine.
The Zecuity patch contains the active ingredient sumatriptan, a prescription medication used to treat acute migraine headaches in adults. The patch delivery system is designed to deliver a dose of medicine 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 more than four hours.
The Zecuity patch was approved in 2013 and hit the market just last fall. Since then, a large number of patients have reported burns or scarring on the skin where the patch was worn. The reports include descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. Those reports led to the FDA probe.
Patients and health care professionals are urged to report possible side effects involving the Zeuity patch to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.