The US Food and Drug Administration (FDA) is looking into the risk for serious burns and potential permanent scarring with the use of the sumatriptan iontophoretic transdermal patch (Zecuity, NuPathe Inc) for migraine, the agency said in a June 2 drug safety communication.
Zecuity, a single-use, battery-powered patch, offers relief of migraine headache pain as well as migraine-related nausea,was approved in 2013 for acute treatment of migraine with or without aura in adults.
According to the FDA, since the product came on the US market in September 2015, a "large number" of patients have reported sustaining burns or scars on the skin where the patch was worn. The reports include severe redness, pain, skin discoloration, blistering, and cracked skin.
"As a result, we are investigating these serious adverse events to determine whether future regulatory action is needed," the agency said. The FDA safety communication does not specify exactly how many patients have reported these adverse reactions.
While the investigation is going on, patients who report moderate to severe pain at the application site should be advised to remove the patch immediately, the FDA said. Using a different formulation of sumatriptan or switching these patients to an alternative migraine medicine should also be considered.
The FDA urges healthcare providers to report possible side effects involving the Zecuity patch to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.