FDA investigates risk of burns, scars with Zecuity patch for migraines

The FDA announced its investigation of the risk for serious burns and potential permanent scarring with the use of the Zecuity patch for treating migraines.

There have been “a large number of patients” who have reported experiencing burns or scars on the skin with the Zecuity patch (sumatriptan iontophoretic transdermal system, Teva Pharmaceuticals) since marketing of the patch began in September 2015, according to an FDA safety alert. Severe redness, pain, skin discoloration, blistering and cracked skin were reported.

“As a result, FDA is investigating these serious adverse events to determine whether future regulator action is needed and will update the public with new information when the FDA review is complete,” according to the alert.

The prescription patch system delivers a dose of medicine through a single-use, battery-powered patch that is wrapped around the upper arm or thigh, and should remain in place no longer than four hours, according to the FDA.

The agency is recommending that patients who experience moderate to severe pain at the patch site should immediately remove it — regardless of how long the patch has been worn — and contact their health care professionals. Patients are also advised not to bathe, shower or swim while wearing the patch.

The FDA is asking health care professionals to advise patients who complain of moderate-to-severe pain at the application site to remove the patch immediately, and to consider a different formulation of sumatriptan or switch patients to an alternative migraine medicine.

The agency is encouraging health care professionals and patients to report adverse events related to the patch to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by submitting a form online, downloading a form, or by calling 1-800-332-1088 to request a form.

Reference: www.fda.gov