Numerous incidents of burns and scarring are being reported in patients who have been treated with Zecuity, a transdermal patch used to treat migraine headaches, prompting an investigation by the Food and Drug Administration (FDA).
Since Zecuity hit the market in September 2015, a large number of patients have reported burns or scars on their skin where the patch was worn. The reports include descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin.
“As a result, FDA is investigating these serious adverse events to determine whether future regulatory action is needed, and will update the public with new information when the FDA review is complete,” the agency said in a Safety Communication.
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 the medicine by way of a single-use, battery powered patch that is wrapped around the upper arm or thigh. It should remain in place no longer than four hours.
The FDA is advising patients who experience moderate to severe pain at the Zecuity patch site to immediately remove it to avoid possible burns or scarring, regardless of how long the patch has been worn, and to contact their doctor. Patients also should not bathe, shower or swim while wearing the patch. The Instructions for Use section in the Patient Insert should also be read before use and any questions should be directed to the prescribing doctor.
Patients who have used the Zecuity patch should report any side effects to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.