Teva Pharmaceutical's Zecuity Patch Linked to Serious BurnsJun 6, 2016
The Zecuity Patch will be undergoing increased scrutiny by the U.S Food and Drug Administration (FDA) due to reports of "a large number of patients" reporting severe burns and scars after using the headache patch made by Teva Pharmaceuticals. Zecuity (sumatriptan iontophoretic transdermal system) is a transdermal, battery-operated medication intended for the treatment of acute migraines.
The attraction to Zecuity is the speed with which it delivers sumatriptan into the patient's bloodstream, as it bypasses the gastrointestinal tract. Teva's Zecuity was approved in 2013 and became available in the United States in September. Sumatriptan (Imitrex) has been on the market for 25 years and is widely prescribed for the treatment of acute migraines, according to Law360.
Zecuity is designed to be worn over a 4-hour period on either the upper arm or thigh. The patch is worn once and then thrown away after use. Since it has been on the market, the Zecuity patch has been connected to an increasing number of reports from patients concerning burns or scars on the skin where the patch was worn. More severe adverse reactions described in an FDA "Safety Communication" indicated the agency is reviewing reports of "serious burns and potential permanent scarring" associated with Zecuity, Law360 wrote.
Reported injuries were: blistering, cracked skin, pain, severe skin redness, and skin discoloration. 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.