According to the U.S. Food and Drug Administration, they are investigating a migraine headache pain patch that has given a “large number” of people severe burns and scarring in the location where they have worn the patch. The sumatriptan iontophoretic transdermal patch, which is used to treat headache pain and nausea, is sold under the brand name Zecuity. It is battery-powered and meant for a single use.
The FDA statement says that people have reported severe redness, blistering, skin discoloration and cracked skin since Zecuity came on the market in September 2015. “As a result, we are investigating these serious adverse events to determine whether future regulatory action is needed.”
The FDA initially rejected the approval of the Zecuity migraine patch due to burns. The version they later approved was redesigned.
The patch can be wrapped around arm or thigh, and is intended to be removed after four hours. The company warns of mild side effects that commonly include itching, pain, tingling, warmth, discomfort, or “a change in the skin color” at the application site. The company says that, although most people have some skin redness after removing the patch, it usually goes away in 24 hours.
The American Headache Societies reports that more than 36 million Americans suffer from migraines, which are not ordinary headaches. Although some migraine sufferers are helped by over-the-counter medications such as ibuprofen, many turn to prescription drugs that act by constricting blood vessels in the brain. About 4 million Americans have chronic migraines and have headaches for 10 to 14 days every month.
The FDA advises that patients who experience pain where the migraine patch is applied remove it immediately and consult their doctor.