FDA Safety Alert: Zecuity Migraine Patches

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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At the beginning of this month the FDA issued a drug safety alert for the migraine patch Zecuity (sumatriptan). At that time, the FDA planned to investigate whether the Zecuity patch came with an increased risk of serious burns and potential permanent scarring.

Now, the FDA has announced that the manufacturer of Zecuity, Teva Pharmaceuticals, has decided to temporarily stop the sales, marketing, and distribution of the Zecuity patch. Teva also plans to investigate the cause of burns and scars associated with the migraine patch.

Taking Zecuity? Here’s what you need to know.

How does Zecuity work?
Zecuity is a topical battery-powered patch system that wraps around the upper arm or thigh. The system works by delivering the migraine medication through the skin by using an electric current.

Is the FDA requiring that Teva pull Zecuity off the market?

No. Teva is voluntarily suspending the sale, marketing, and distribution of Zecuity beacuse of the reports of serious reactions. They plan to find out the cause.

How did the FDA find out about the risk of burns and scarring from Zecuity?

Since the marketing of Zecuity began in September 2015, a large number of patients have reported to the FDA that they have experienced burns or scars on the skin where the patch was worn.

Reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin.

Have any of the reactions healed?

Yes. Many of the reported cases got better within hours to weeks, however, there are still cases with ongoing skin reactions after several months, typically discoloration.

Can my doctor still prescribe Zecuity for my migraines?

No. The FDA has advised health care providers to stop prescribing Zecuity patches until further notice.

What should I do if I still have some unused Zecuity patches?

The FDA recommends that if you have leftover patches, you should still stop using Zecuity and contact your health care provider to find an alternate migraine medication.

The manufacturer is also offering a Migraine Support Solutions help line at 1-855-ZECUITY (1-855-932-8489) for additional information and instructions regarding leftover Zecuity patches.

I want to keep using the same medication—what are my options?

The active ingredient in Zecuity the popular migraine medication sumatriptan, so you have lots of options. Generic sumatriptan (Imitrex) is available in tablet, nasal spray, and injection forms. Other migraine medications containing sumatriptan include Alsuma, Sumavel Dosepro, and Zembrace.

Talk to your health care provider about which sumatriptan (or other migraine medication) might be a good alternative for you.

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