Drug Safety Alerts

Zecuity® (sumatriptan) Migraine Patch Drug Safety Communication

06/13/2016


On June 13, 2016, the United States Food and Drug Administration (FDA) issued a MedWatch to advise that Teva Pharmaceuticals has temporarily suspended sales, marketing, and distribution to investigate the cause of burns and scars associated with the Zecuity^® (sumatriptan iontophoretic transdermal system) patch.  Health care providers should discontinue prescribing Zecuity, and patients should stop using any remaining patches and contact their prescribers for an alternative migraine medicine. 

The FDA is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity for migraine headaches. Since marketing of the Zecuity 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.

Health care providers are encouraged to report adverse events or side effects related to the use of this product to the FDA.

For more information about this issue, health care providers may contact Teva Medical Information at 1-800-896-5855. You may also contact the FDA consumer inquiry line at 1‑888-INFO-FDA (1-888-463-6332) or visit http://www.fda.gov.