Teva Pharmaceuticals, the manufacturer of the Zecuity patch used for the treatment of symptoms of migraine headaches, has decided to temporarily suspend sales, marketing and distribution of its product and to investigate the cause of burns and scars reported by users. Doctors should discontinue prescribing Zecuity and patients should not use any remaining patches as well as contact their health professionals for an alternative migraine medicine, reports FDA MedWatch.
The U.S. Food and Drug Administration (FDA) is investigating complaints of serious burns, and their potential scarring, with use of the Zecuity (sumatriptan iontophoretic transdermal system) patch. Zecuity has been on the market since September 2015. The complaints by a large number of patients have been burns or scars appearing on the sites where the patch was worn, MedWatch reports.
The reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. The FDA is examining these serious adverse events to determine whether future regulatory action is needed. The public will be updated when the FDA review is complete, according to MedWatch.
The design is a battery-powered patch that is wrapped around the upper arm or thigh and should remain in place for no longer than four hours. It is recommended not to bathe, shower, or swim while wearing the patch.
Zecuity’s label lists skin redness as the patch’s most common side effect and says that any discoloration disappears normally within 24 hours. According to the label, “intense redness” or “intense redness with blisters/broken skin” were reported in 6 percent of clinical-trial patients within four hours of using Zecuity, a figure that fell to 2 percent within 24 hours, reports Law360.