Side effects of the migraine patch Zecuity may include a risk of burns and scars, according to warnings issued this week by federal drug regulators.
The FDA issued a drug safety communication on June 2, announcing that the agency has launched an investigation into the risk of Zecuity burns and scarring.
Although the migraine patch has only been on the market since September 2015, the FDA indicates that it has already received a large number of adverse event reports involving patients who say they experienced problems with burning or scarring in the location the patch was applied.
Zecuity (sumatriptan) is a battery-powered transdermal patch sold by Teva Pharmaceuticals, which was approved last year for the treatment of migraine headaches. The patch is designed to be worn on the arm or thigh for four hours and then discarded.
“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 FDA warns. “The reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin.”
The FDA safety review into the potential skin side effects of Zecuity was launched as a result of these reports, which the agency has classified as serious adverse events. The agency did not specify how many incidents had been reported, and indicated that it will provide more information when the FDA review is complete and it decides whether additional regulatory action is necessary. It is unlikely that a Zecuity recall will be issued, but stronger warnings or precautions may be recommended if the agency identifies a means mitigating the burn risk with Zecuity.
In the interim, the FDA is recommending that patients who wear the patch and experience moderate to severe pain where the patch is worn immediately remove it to avoid the risk of burns and scarring, and contact their healthcare professional. The agency also warns that the patch should not be worn while bathing, showering or swimming.
The FDA is advising healthcare professionals to warn patients that they should remove the patch if they experience moderate to severe pain at the application site as well. The agency advises doctors to consider a different formulation of sumatriptan or switch the patients to an alternative migraine medication if this occurs. They should also evaluate the patient and the application site as needed, the FDA advised.
The FDA is calling for healthcare professionals and patients who experience adverse events or side effects while wearing the patch to submit a report to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.