Sales of the Zecuity Migraine Patch were suspended last year after numerous patients reportedly experienced burns and scarring at the application site. Unfortunately, a review of Zecuity’s troubled approval history indicates that these safety issues were actually a long-standing problem.
The Zecuity Migraine Patch (sumatriptan iontophoretic transdermal system) is a single use, battery operated device that is designed to be wrapped around the upper arm or thigh. Once in place, Zecuity delivers 6.5 milligrams of sumatriptan directly through the skin for four hours. It was approved in January 2013 to treat adults suffering from migraine headaches with or without auras.
Zecuity was developed by NuPathe, Inc., a company that was acquired by Teva Pharmaceuticals in 2014. Teva began marketing the migraine patch in September 2015. Less than a year later, the Israel-based company announced it was suspending sales of the Zecuity Migraine Patch due to numerous reports of burns and potentially permanent scarring. The reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin.
Unfortunately, this was not the first time the Zecuity Patch had been associated with burns and scars. According to an investigation conducted by reporters at MedPage Today and the Milwaukee Journal-Sentinel, the FDA initially refused to approve Zecuity, after the agency raised concerns that it could “cause severe burns and permanent skin lesions.” The migraine patch was ultimately redesigned and tested on just 58 people, none of whom reported problems. However, the FDA did order Teva to report any Zecuity-related adverse events within 15 days of receiving any complaint.
Nine months after its launch, hundreds of Zecuity Patch users had reported burns, scars and other adverse skin reactions. On June 2, 2016, the FDA announced that it had launched an investigation into the problems. Teva voluntarily suspended sales a week later.
More than a year later, the Zecuity Patch remains off the market. To date, Teva has been unable to determine the root cause of its safety problems.
The Zecuity Migraine Patch has never been officially recalled. However, doctors and patients have been warned not to use the device. Adverse skin reactions associated with its use have been characterized by:
Patients who do decide to use Zecuity in spite of the FDA’s warning should remove it immediately and contact their doctor if they experience moderate to severe pain at the application site.