Recall of Zecuity Migraine Patch as FDA Evaluating Risk of As FDA Investigates Burns and Scars

Zecuity is the first skin patch approved for the treatment of migraine.
Zecuity is the first skin patch approved for the treatment of migraine.

Zecuity manufacturer Teva Pharmaceuticals has suspended sales, marketing, and distribution to investigate the cause of burns and scars associated with the Zecuity migraine patch.

Health care professionals should stop prescribing Zecuity, and patients should stop using any remaining patches and contact their prescribers for an alternative migraine medicine.

Refer to the Dear Health Care Provider letter and the updated Drug Safety Communication for more information.

The 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, many 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.

Serious adverse events

As a result, FDA is investigating these serious adverse events to decide whether future regulatory action is needed, and will update the public with new information when the FDA review is complete.

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.

Zecuity was approved by the FDA in January 2013. At the tim NuPathe Inc., the makers and marketers of Zecuity, the patch is effective in treating migraine headache pain as well as migraine-related nausea.

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.

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