The FDA has warned patients and doctors about the Zecuity patchIf you are using a Zecuity patch to treat your migraines, then you should stop and call your doctor for another treatment now.

On June 10, 2016, Teva Pharmaceuticals, the company that makes Zecuity patches, suspended sales of the medication to look into a serious health risk. According to the U.S. Food and Drug Administration (FDA), patients should stop using Zecuity patches and should contact their doctors for alternative treatment options.

What Is a Zecuity Patch?

In January 2013, the FDA approved Zecuity to treat migraine pain and nausea. Zecuity is a battery-operated skin patch that delivers migraine medication through the skin. Zecuity, also known as sumatriptan iontophoretic transdermal system, could be applied to the upper arm or thigh during a migraine. This delivery system allowed the medication sumatriptan to work without having to go through the gastrointestinal tract.

Since the Zecuity patch began being marketed in the United States in September 2015, the FDA has received a “large number” of reports about burns or scars on the skin where the patch was applied. Specifically, the FDA received reports about:

  • Severe redness.
  • Pain.
  • Skin discoloration.
  • Blistering.
  • Cracked skin.

These reports of symptoms of burns and scars led to further action in June 2016.

June 2016 Safety Announcement About Zecuity Patches

On June 2, 2016 the FDA issued a safety communication regarding Zecuity. In that communication the FDA described the symptoms of burns or scars as listed above, and recommended that patients who experience moderate or significant pain remove the patch immediately and contact a medical professional.

Not even two weeks later, a further communication was provided to patients and healthcare providers. The FDA updated its June 2 Safety Announcements with a letter from Teva Pharmaceuticals (“Teva”) to healthcare providers.

Teva’s June 10, 2016 letter informed healthcare providers that it was suspending sales of Zecuity because of reports of burns or scars on the skin where the patch had been worn. Despite this voluntary drug recall, Teva indicated that its investigation into the safety of Zecuity would continue. As part of the recall, Teva asked doctors and other healthcare providers to:

  • Stop prescribing Zecuity.
  • Instruct patients to stop taking Zecuity.
  • Evaluate the skin where the Zecuity patch was used if patients report adverse reactions.
  • Advise patients on how to properly dispose of unused patches.
  • Report adverse reactions to Teva and to the FDA.

Patients should talk to their doctors about alternative ways to treat their migraines and should know what further action to take if they are hurt.

What to Do If You’ve Been Burned or Scarred by a Zecuity Patch

The first thing that you should do if you see any signs of a burn or experience any pain is to take off the patch and consult with your doctor. Your doctor will advise you about treating your pain, about preventing your condition from worsening, and about different treatment for your migraines. Additionally, your medical record will be important if you pursue a legal recovery.

Once your immediate medical needs have been addressed, then you should consider taking further action, such as protecting your legal rights. This may include:

  • Taking photographs of your injury. The pictures, combined with prescription information from your medical record, may be important evidence.
     
  • Reporting the adverse event to the FDA. You can file an FDA adverse event report online or you can call the FDA at 1-800-322-1088 to request a form which you can then complete and mail back to the FDA. Keep a copy of your report of your records.
     
  • Contacting an experienced drug injury lawyer. An attorney can evaluate the unique facts of your injury, advise you of your rights, and help you with the complicated and important matter of pursuing justice.
     

To learn more, please contact the legal team at Gray & White Law today. We are available 24 hours a day, seven days a week to answer your questions. Call us today at 888-450-4456 to schedule your own free, no-obligation consultation and to find out more about your rights and potential recovery.

Matthew L. White
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Founder & Partner of Louisville Personal Injury Law Firm Gray & White Law

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