FDA To Investigate Migraine Patch For Burns And Scarring Issues

As the U.S. Food and Drug Administration (FDA) begins probing into the risk of serious burns and scarring with the use of Zecuity patch for migraine headaches, the pharmaceutical manufacturer voluntarily and temporarily suspends sales, marketing and distribution of the patch.

In a letter addressing healthcare professionals, Teva Pharmaceuticals – Zecuity manufacturer – advises that healthcare professionals to discontinue prescribing the patch. Dr Denia Hurtukova, Vice President, Teva Pharmaceuticals, instructs patients to abstain from using any remaining patches and contact their doctors for an alternative medicine for migraine.

Since its marketing in 2015, Teva has been receiving post-marketing reports of adverse drug reactions in patients treated with Zecuity. Patients reported burns, soreness, cracked skin, severe itching, pain, blistering or scars where the patch was worn. Most of the cases resolved within hours to weeks of the patch application. Some cases, however, lingered and reported unresolved skin reactions, including skin discoloration, several months after the use of migraine patch.

The Teva letter continues with a probable action plan for prescribers, i.e. it instructs healthcare professionals to report adverse drug events, provide patient education regarding the patch and suggests contacting Migraine Support Solutions at 1-855-ZECUITY (1-855-932-8489) for information regarding the disposition of unused patches.

The Zecuity patch is a single-use, battery-powered transdermal patch that is wrapped around the upper arm or thigh where it delivers the drug over an extended period of time. An electric current moves the drug from the patch into the skin and ultimately to the blood. It is indicated for acute treatment of migraine with or without aura.

However, ever since its marketing in September 2015, the reports have not been quite encouraging for the pharmaceutical company. Scores of patients reported experiencing burns or scars on the skin. The unexpected adverse drug events prompted the FDA into taking an action.

FDA Press Release

On June 2, 2016, FDA announced in a press release that it is investigating the risks associated with the patch. “We are investigating the cause and extent of these serious side effects and will update the public with new information when our review is complete,” states the press release.

Meanwhile FDA instructs patients  not to bathe, shower, or swim while wearing the patch. They should immediately remove the patch if there is moderate to severe pain at the application site. The patients should either be switched to a different formulation of the drug or prescribed an alternative medicine.

In order to address the root cause of adverse skin reaction linked with the transdermal patch, Teva Pharmaceuticals has decided to voluntarily suspend sales, marketing, and distribution of Zecuity. Teva Pharmacueticals is collaborating closely with FDA.

Zecuity (Sumatriptan Iontophoretic Transdermal System) Patch

It is a transdermal system used to treat migraines in adults. It wards off migraine headache by slowly releasing 6.5 mg of sumatriptan over a period of four hours. It is used to treat, not prevent, migraine headache. The patch is single-use only. Teva recommends using no more than two Zecuity patches in 24 hours. Its common side effects include tingling, itching, discomfort, irritation, pain, skin discoloration, bruising, rash, and skin lesions or cysts.

Sumatriptan is a synthetic drug that belongs to the triptan class. It is an analog of naturally occurring alkaloids and successfully resolves the stubborn migraine headaches. It is most effective when taking prophylactically and injected under the skin, i.e. in a transdermal patch.

FDA approved Zecuity patch in 2013.


Migraine is a primary headache disorder characterized by severe, recurrent headaches affecting half of the head. The headaches are pulsating in nature and typically last from 2  to 72 hours.

Migraine headaches are severe and different from other types of headaches such as tension headache and sinus headache.

According to the National Institutes of Health (NIH), almost 12% of Americans have migraine headaches. It affects both children and adults, but the frequency is highest among adult women being  almost three times that of men.

Migraine has following characteristic features:

  • Pain typically begins on one side of the head and has a throbbing quality.
  • Pain may be moderate to severe but is sufficient to affect daily activities.
  • Nausea or vomiting
  • Photosensitivity
  • Aura – visual disturbances that signal the beginning of the headache. These include disrupted visions and appearance of dots, flashing lights or blind spots in front of eyes.

Other Drugs To Treat Migraine

Aside from Zecuity, FDA has approved a number of drugs for treating acute migraine. These include Imitrex (a triptan) that binds to serotonin receptors in the neurons. Other over-the-counter drugs for migraine include  ibuprofen, aspirin and acetaminophen.

In October 2010, FDA also approved Botox (Botulinum toxin) for treating chronic migraine lasting for at least 15 days a month.

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