The U.S Food and Drug Administration (FDA) received reports of “a large number of patients” complaining of severe burns and scars after using the migraine headache patch made by Teva Pharmaceuticals. Zecuity (sumatriptan iontophoretic transdermal system) is a transdermal, battery-operated medication for the treatment of acute migraines.
Teva’s Zecuity was approved in 2013 and became available in the United States in September. Sumatriptan (also known as Imitrex) has been on the market for 25 years and is widely prescribed for the treatment of acute migraines, according to Law360.
For those suffering from migraine headaches who may have an aversion to injections, zecuity is an attractive alternative. It is faster acting than tablets and minimizes any nausea associated with migraines as it bypasses the gastrointestinal tract. The patch is fairly large, about the size of a palm and is worn on the upper arm or thigh.
The problems reported and described in an FDA “Safety Communication” indicated the agency is reviewing reports of “serious burns and potential permanent scarring” associated with Zecuity, Reported injuries were: blistering, cracked skin, pain, severe skin redness, and skin discoloration, reports Law360.
FDA officials stated, “As a result, we are investigating these serious adverse events to determine whether future regulatory action is needed” and wrote that patients should “immediately remove” Zecuity and contact their physician should they experience moderate to severe pain at the Zecuity application site, no matter how long the Zecuity has been on the skin, to avoid the potential for burns or scars. It is recommended that patients do not bath, shower or swim while wearing the patch.