Teva Headache Patch Has Burned Many Patients, FDA Says
By Jeff Overley
Law360, New York (June 2, 2016, 7:21 PM ET) -- The U.S. Food and Drug Administration on Thursday reported that “a large number of patients” have suffered severe burns and scars after using a migraine headache patch sold by Teva Pharmaceuticals and that the product’s safety is getting fresh scrutiny.
In a safety communication, the FDA said it is investigating reports of “serious burns and potential permanent scarring” in connection with Zecuity, a transdermal patch approved in 2013 for the treatment of migraines and launched in the U.S. in September.
The battery-powered patch is worn on the upper arm or thigh for up to four hours and delivers sumatriptan, a widely prescribed anti-migraine drug that’s been on the market for 25 years. Common side effects of Zecuity include skin redness and discomfort, but the FDA on Thursday described adverse events that have been much more alarming.
“The reports included descriptions of severe redness, pain, skin discoloration, blistering and cracked skin,” FDA officials said. “As a result, we are investigating these serious adverse events to determine whether future regulatory action is needed.”
In a statement on Thursday, Israel-based Teva said it is “working closely with the FDA on the investigation.”
“At Teva, there is nothing more important to us than the health and safety of those who use our products,” the company said.
The agency said that patients should “immediately remove” Zecuity and contact a doctor if they experience moderate to severe pain at the application site. In such situations, a different drug or a different formulation of sumatriptan should be considered, according to the FDA.
Teva acquired Zecuity in 2014 when it purchased Pennsylvania-based NuPathe Inc. for nearly $115 million. The product’s main selling point is its ability to deliver sumatriptan into the bloodstream more quickly than pills by skipping the gastrointestinal tract.
Other skin patches have generated serious cosmetic concerns in the past. For example, the FDA last year warned that the Daytrana patch sold by Noven Pharmaceuticals Inc. to treat attention deficit hyperactivity disorder could cause permanent loss of skin color.
--Additional reporting by Dani Kass. Editing by Philip Shea.
