Zecuity Tied to Serious Burns and Scarring
Teva Pharmaceutical’s Zecuity (Sumatriptan Iontophoretic Transdermal System) Tied to Serious Burns, Scarring, Say Federal Regulators
Zecuity (sumatriptan iontophoretic transdermal system) is a transdermal, battery-operated medication used to treat acute migraines. In June 2016, federal regulators reported that “a large number of patients” have reported suffering severe burns and scars following use of the migraine headache patch, Zecuity, sold by Teva Pharmaceuticals. The U.S. Food and Drug Administration (FDA) also indicated that the Teva Headache Patch’s safety will be undergoing new scrutiny.
If you have been treated with Zecuity and experienced a serious adverse health event, such as skin burn or scarring, the attorneys at Parker Waichman would like to hear from you.
What is Zecuity?
Teva’s Zecuity received approval in 2013; the patch was launched in September in the United States, according to Law360. Zecuity is worn on the upper arm or thigh for up to four hours, delivering sumatriptan, a broadly prescribed medication used for the treatment of acute migraines. Sumatriptan has been on the market for 25 years.
Zecuity’s main selling point is that it delivers sumatriptan into the patient’s bloodstream more rapidly than pills, as the gastrointestinal tract is not involved.
Reports of Serious Skin Reactions Tied to Zecuity
The FDA is investigating the risk of serious burns, as well as the potential for permanent scarring with the use of the Zecuity patch. Since its release to the market, the Zecuity patch has been associated with a mounting number of reports from patients over burns or scars on the skin at the location where the patch was worn. Patients have also described more severe adverse reactions outlined in an FDA “Safety Communication” that also indicated the agency is reviewing reports of “serious burns and potential permanent scarring” tied to Zecuity, wrote Law360. Injury reports included:
- Cracked Skin
- Severe skin redness
- Skin discoloration
FDA officials noted, “As a result, we are investigating these serious adverse events to determine whether future regulatory action is needed” and wrote that patients should “immediately remove” Zecuity and contact their physician should they experience moderate to severe pain at the Zecuity application site, no matter how long the Zecuity has been on the skin, to avoid the potential for burns or scars. A different drug or different formulation of sumatriptan should be considered, should adverse reactions occur, according to the FDA. Patients are advised against bathing, showering, or swimming while wearing the patch.
Legal Help for Individuals who Have Used Zecuity and Experienced Burning, Scarring, Severe Skin Reactions
If you used Zecuity (sumatriptan iontophoretic transdermal system) and suffered a serious side effect such as burning, scarring, and other severe skin reactions, you may have valuable legal rights. Please contact Parker Waichman at 1-800-YOURLAWYER (800-968-7529) to speak with our attorneys today.