June 13, 2016 — Teva Pharmaceuticals’ migraine patch Zecuity has been pulled off the market after being linked to reports of severe burns and permanent scarring.
On June 10, Teva Pharmaceuticals send a “Dear Doctor” letter (PDF) to healthcare professionals about Zecuity after receiving post-marketing reports of application site reactions that included burns and scars.
Teva said many cases resolved within hours or weeks, but there are reports of long-term skin problems — typically skin discoloration — after several months. According to the letter:
“Descriptions of these reactions have included severe redness, cracked skin, blistering or welts, and burns or scars where the patch was worn. Patients described severe pain, itching, or burning.”
Teva asked doctors not to prescribe Zecuity and tell patients with existing prescriptions to stop using it. The company will suspend sales, marketing, and distribution to investigate the cause of burns and scars.
On June 2, the FDA issued a Safety Communication to report a “large number of patients” had experienced “severe redness, pain, skin discoloration, blistering, and cracked skin” when using Zecuity.
Zecuity was approved in September 2015 for the treatment of migraine headaches. The single-use battery-powered patch is worn on the upper arm or thigh for up to four hours. It uses a small electrical current to deliver the active drug sumatriptan through the skin. The drug is also available in pill form under the brand-name Imitrex.
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