Zecuity (sumatriptan) Migraine Patch: UPDATED Drug Safety Communication – FDA Evaluating Risk of Burns and Scars

UPDATED 06/13/2016:

Zecuity manufacturer Teva Pharmaceuticals has decided to temporarily suspend sales, marketing, and distribution to investigate the cause of burns and scars associated with the Zecuity patch.  Health care professionals should discontinue prescribing Zecuity, and patients should stop using any remaining patches and contact their prescribers for an alternative migraine medicine.  Please refer to the Dear Health Care Provider letter and the updated Drug Safety Communication for more information.

ISSUE:

FDA is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch 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. As a result, FDA is investigating these serious adverse events to determine whether future regulatory action is needed, and will update the public with new information when the FDA review is complete.

BACKGROUND:

The Zecuity patch contains the active ingredient sumatriptan, a prescription medicine used to treat acute migraine headaches in adults. The patch delivery system is designed to deliver a dose of medicine by way of a single-use, battery-powered patch that is wrapped around the upper arm or thigh. It should remain in place for no longer than four hours.

RECOMMENDATION:

Patients who experience moderate to severe pain at the Zecuity patch site should immediately remove it to avoid possible burns or scarring, regardless of how long the patch has been worn, and contact your health care professional. Do not bathe, shower, or swim while wearing the patch. Read the Patient Information leaflet and the Instructions for Use section in the drug label, and talk with your health care professional if you have any questions or concerns.

Click here to view the updated MedWatch Safety Alert, with links to the Dear Health Care Provider letter and the updated Drug Safety Communication.

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