FDA Evaluating the Risk of Burns, Scars With Sumatriptan Migraine Patch

The US Food and Drug Administration (FDA) is investigating the risk of serious burns and potential permanent scarring with the use of sumatriptan iontophoretic transdermal system patch (Zecuity) for migraine headaches.

The FDA is investigating the cause and extent of these serious side effects and will update the public with new information when the review is complete.

Patients who experience moderate to severe pain at the patch site should immediately remove it to avoid possible burns or scarring, regardless of how long the patch has been worn, and contact their healthcare professional. Patients should not bathe, shower or swim while wearing the patch.

Healthcare professionals should advise patients who complain of moderate to severe pain at the application site to remove the patch immediately. Healthcare professionals should consider a different formulation of sumatriptan or switch these patients to an alternative migraine medicine. Evaluation of patients and the application site should be done as needed.

Since marketing of the sumatriptan 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 reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. As a result, the FDA is investigating these serious adverse events to determine whether future regulatory action is needed.