The U.S. Food and Drug Administration (FDA) is investigating allegations that the Zecuity migraine patch has serious adverse side effects. The FDA has received reports of serious burns, with possible permanent scarring. The Zecuity patch (sumatriptan iontophoretic transdermal system) has been available since 2015.
Numerous patients have reported they suffered burns or scars on the skin where the patch was worn. The reports included descriptions of pain, severe redness, skin discoloration, blistering, and cracked skin.
Zecuity is made by Teva Pharmaceuticals and due to the adverse reports, has voluntarily suspended sales, marketing and distribution of its patch. The company is investigating the reason for the alleged burns associated with the Zecuity migraine patch.
What is a Migraine?
A migraine is more than just a bad headache. It is an extremely debilitating condition that can keep you from performing daily tasks. A migraine usually includes a severe, recurring, intense throbbing pain on one or both sides of the head, and attacks can last between four and 72 hours.
Adverse Zecuity Events
Due to reports, the FDA is examining these serious adverse events to decide whether regulatory action is needed to be taken in the future and says it will provide new information when the FDA review is complete.
The active ingredient in the Zecuity patch is sumatriptan, which is a prescription medication used to treat migraine headaches in adults. The patch is designed to deliver a dose of medicine by way of a single-use, battery-powered patch. The patch is wrapped around the upper arm or thigh and should remain in place for no longer than four hours.
The Zecuity patch was approved by the FDA in January 2014, and is the first skin patch to be marketed for the treatment of migraines. At that time, NuPathe, Inc., the makers and marketers of Zecuity said the patch is effective in treating migraine headache pain as well as migraine-related nausea.
In promoting the Zecuity patch a study was cited that Zecuity outperformed a non-medicated patch in reducing headache pain and cutting light-sound sensitivity. However, it was on the American market less than a year when it began to have reports of causing burns and potential scarring.
Individuals who experience moderate to severe pain at the Zecuity patch site should remove it to avoid potential burns or scarring and should immediately contact a health professional. The patient should not bathe or shower while wearing the patch.
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Although most cases resolve within hours to weeks, cases of unresolved skin reactions, typically skin discoloration, after several months were reported, the Teva letter said.
Common Zecuity Side Effects
According to Rx List typical Zecuity side effects are pain, itching, tingling or numbness, discomfort, warmth, discoloration, irritation, bruising, dermatitis (rash), skin lesions, and changes in skin color.
No more than two Zecuity patches should be used in any 24-hour period. A second Zecuity patch should be used no sooner than two hours after activation of the first patch. Zecuity may interact with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepimephrine reuptake inhibitors (SNRIs) such as Celexa, Cymbalta, Effexor, Pritiz, Prozac, and Zoloft. These may cause a potentially life-threatening condition called serotonin syndrome.
Zecuity may also interact with ergot drugs, monoamine oxidase inhibitors (MAOIs), and other 5-HT1 drugs such as triptans.
Zecuity contains metal parts and must be removed before an MRI procedure. Patients with a heart disease should not use Zecuity. Also, patients with a history of heart disease or stroke, peripheral vascular disease, transient ischemic attack (TIA), problems with blood circulation, or uncontrolled blood pressure should not use Zecuity.
In two long-term, open-label studies in which patients were allowed to treat multiple migraine attacks for up to one year, 15 percent (99 out of 662) withdrew from the study because of adverse reactions. The most common adverse reaction that led to withdrawal from the study were contact dermatitis (4 percent) and application site pain (4 percent).
The most common adverse reactions in a controlled single dose study were application site pain, paresthesia (numbness or tingling), pruritus (itching), warmth, and discomfort.