Notification for the withdrawal of the patch has come from the U.S. Food and Drug Administration (FDA). The patch — Zecuity (generic name sumatriptan) — in manufactured by the pharmaceutical company Teva.
Sumatriptan is a synthetic drug belonging to the triptan class and it is designed for treating migraines. Sumatriptan reduces the vascular inflammation associated with migraines. Migraines are a form of headache, although there are a number of associated symptoms that make the condition far worse than ordinary headaches. Symptoms may include nausea, vomiting, and sensitivity to light, sound, or smell.
Zecuity comes in the form of a transdermal patch. The patch is designed to deliver sumatriptan through the skin using iontophoresis (noninvasive method of delivering a drug through the skin using a low electrical current — for this the patch contains two small batteries.)
Each patch is designed for single use. To use the patch is placed on the upper arm or thigh and there is a maximum use time of four hours.
The drug Zecuity has been suspended for the short-term (which includes manufacture, sales, marketing, and distribution) to allow for an investigation into some reported burns and permanent scars following the use of the patch.
Additionally, FDA has advised, via its MedWatch service, that healthcare professionals discontinue prescribing Zecuity, and that patients should stop using any remaining patches they have at home.
Zecurity is a relatively new product, having first been marketed in September 2015. FDA was concerned with the number of reports relating to burns and scars. Additional symptoms included redness, pain, skin discoloration, blistering, and cracked skin.
Both the manufacturer and FDA are starting investigations into the use of the medicinal product. The news has been picked up by a number of consumer groups, including Migraine.com (@Migrainedotcom) who tweeted several thousand followers on Twitter about the suspension of the product.
