Teva announced a temporary suspension in the sale, marketing, and distribution of Zecuity (sumatriptan) iontophoretic transdermal system to investigate the cause of burns and scars associated with the patch.
Zecuity is indicated to treat acute migraine headaches in adults. The patch delivers a dose via a single-use, battery-powered patch that is wrapped around the upper arm or thigh. The patch should not be worn for more than 4 hours.
Since its launch in September 2015, many patients have reported burns or scars on their skin where the patch was worn. Reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. Though many cases resolved within hours to weeks, there were some cases with unresolved skin reactions, typically skin discoloration, after several months. A safety warning was issued earlier this month regarding this risk of serious burns and potential permanent scarring.
The FDA is evaluating whether further regulatory actions is required. At this time, healthcare professionals should stop prescribing Zecuity and patients should stop using any remaining patches; patients should contact their prescribers for an alternative migraine therapy. The FDA will update the public with new data after completing their review.
For more information call (800) 896-5855 or visit FDA.gov.