The FDA is investigating the risk of serious burns and potential permanent scarring with the use of Teva’s iontophoretic transdermal patch Zecuity to treat acute migraine headaches.
Since September 2015, numerous patients have reported burns or scars on the skin where the patch was worn, according to the agency.
The patch delivers a dose of sumatriptan using iontophoresis — a drug delivery method using a low electrical current with a single-use battery-powered patch wrapped around the upper arm or thigh.
In two long-term, open-label studies in which patients were allowed to treat multiple migraine attacks for up to one year, 15 percent withdrew from the study because of an adverse event.
The most common adverse events were application-site pain, contact dermatitis, paresthesia and discomfort.
Clinicians are advised to consider a different formulation of sumatriptan or to switch patients to an alternative migraine medicine.
The FDA is investigating adverse events to determine whether future regulatory action is needed.