The Food and Drug Administration (FDA) announced this month that “a large number” of people who have used the Teva Pharmaceuticals’ Zecuity migraine headache patch have reported severe burns and scarring. The FDA said it is investigating the Zecuity Headache Patch’s safety.
The Zecuity (sumatriptan iontophoretic transdermal system) is a system for quickly delivering the migraine medication sumatriptan through a transdermal, battery-operated system. Sumatriptan, a migraine medication that has been available for 25 years, helps to relieve headache pain and migraine symptoms including nausea, vomiting, and sensitivity to light and sound.
Sumatriptan belongs to the class of drugs known as triptans, which affect serotonin, a natural substance that causes narrowing of blood vessels in the brain. The drug may also relieve pain by affecting certain nerves in the brain.
Teva’s Zecuity migraine headache patch received FDA approval in 2013 and came to market in September 2015, according to Law360. The Zecuity patch is worn on the upper arm or thigh for up to four hours and delivers sumatriptan to help relieve acute migraines.
A major selling point for Zecuity point is that the patch delivers sumatriptan into the bloodstream more quickly than pills because the medication does not have to go through the gastrointestinal tract.
The FDA is investigating reports of serious burns and the risk of permanent scarring among users of the Zecuity patch. Since Zecuity came to market, the patch has been associated with steadily increasing reports from patients who have experience burns or scars on the skin where the patch was worn. Patients have described serious adverse reactions including blistering, cracked skin, pain, severe skin redness, and skin discoloration.
In a safety communication, the FDA noted, “[W]e are investigating these serious adverse events to determine whether future regulatory action is needed.” The agency advised patients to “immediately remove” the Zecuity patch and contact a doctor if they experience moderate to severe pain at the Zecuity application site, even if the patch has been on the skin for only a short time. The FDA explains that the individual may need a different drug or a different formulation of sumatriptan if he or she has an adverse reaction to Zecuity. The FDA says Zecuity users should not bathe, shower, or swim while wearing the patch.