Teva Pharmaceuticals has decided to temporarily suspend sales, marketing, and distribution of its Zecuity sumatriptan iontophoretic transdermal system, or migraine patch, to investigate the cause of burns and scars associated with the product. The FDA has advised health care professionals to discontinue prescribing Zecuity. Patients should stop using any remaining patches and contact their prescribers for an alternative migraine medication.
Since marketing of the Zecuity patch began in September 2015, the FDA has received numerous reports of burns or scars on the skin where the patch was worn. The reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. As a result, the agency is investigating these serious adverse events to determine whether future regulatory action is needed.
The Zecuity patch contains the active ingredient sumatriptan, a prescription medication used to treat acute migraine headaches in adults. The delivery system is designed to deliver a dose of sumatriptan by way of a single-use, battery-powered patch that is wrapped around the upper arm or thigh. The patch should remain in place for no longer than four hours.
Sources: FDA; June 13, 2016; and Teva Pharmaceuticals; June 13, 2016.