The FDA is warning about the risk of severe burns and permanent scarring from Zecuity migraine patch made by Teva Pharmaceuticals.
Zecuity Migraine Patch Recalled
June 10, 2016 — Teva Pharmaceuticals has recalled Zecuity due to a large number of reports involving severe burns and permanent scarring. Click here to read more.
Zecuity is a patch that contains an active drug called sumatriptan, a prescription drug used to treat acute migraine headaches in adults. The battery-powered patch is wrapped around the upper arm and delivers a single dose for up to four hours.
FDA Safety Warning
June 2, 2016 — The FDA is investigating the risk of severe burns and scars from Zecuity after receiving a “large number” of reports since it was approved in September 2015.
Migraine Patch Skin Reactions
- Scars on the skin where the patch was worn
- Severe redness
- Skin discoloration
- Cracked skin
What is the problem?
An electrical current helps deliver the drug through the skin, which may cause a slight tingling sensation or mild burning in the first 30 seconds. In clinical trials, about 25% of patients complained about pain at the site of the bandage. Even more patients complained about redness the patch left behind.
Skin Problems are Common Side Effect
The manufacturer, Teva Pharmaceuticals, warns that the most common side effects of Zecuity include pain, tingling, itching, warmth, discomfort, and a change in skin color under the patch. According to the label:
“Most people have some skin redness after removal of Zecuity. This redness will usually go away in 24 hours. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.”
Recommendation for Patients
Patients who experience moderate to severe pain while using Zecuity should remove it immediately, regardless of how long it has been worn, and contact a health care professional. Do not bathe, shower, or swim while wearing the patch.