FDA, Teva Pharmaceuticals announce sales suspension of Zecuity patch

The FDA and Teva Pharmaceuticals announced that Teva has voluntarily suspended sales, marketing and distribution of the Zecuity patch.

“Health care professionals should discontinue prescribing Zecuity, and patients should stop using any remaining patches and contact their prescribers for alternative migraine medicine,” the FDA reported in a press update.

Earlier this month, the FDA announced its investigation of the risk for serious burns and potential permanent scarring with the use of the Zecuity (sumatriptan iontophoretic transdermal system) patch for treating migraines.

Teva reported in a press release that it has received postmarketing reports of application site reactions “described as burns and scars” in patients treated with Zecuity, and reported it is working in cooperation with the FDA to analyze reports and investigate the root cause.

Teva reported it also has initiated a pharmacy-level recall of the product.

“At Teva, the well-being of people using our products is always the first priority,” Rob Koremans, MD, president and CEO of Global Specialty Medicines at Teva, stated in the release. “We will continue to work closely with the FDA to resolve any remaining questions.”

Teva has issued an alert to the prescribing community through a “Dear Health Care Provider Letter.”

Patients and health care providers are asked to report any suspected adverse events to Teva at 1-800-896-5855 or to the FDA at 1-800-FDA-1088. Adverse events also may be reported at the FDA’s Medwatch Event Report Program, according to the release.

Reference: www.fda.gov; www.tevapharm.com