Zecuity® Now Under FDA Scrutiny; Drug May Be Linked to Permanent Burns and Scars

According to the National Headache Foundation (NHF), over 28 million Americans suffer from migraines, or about 12 percent of the entire U.S. adult population. With such a high volume of sufferers, it’s no wonder that the corporations of the pharmaceutical industry are scrambling over one another for new solutions to what is – more or less – a household problem.

Enter: Zecuity® (sumatriptan iontophoretic transdermal system). The relatively new prescription patch system designed by NuPathe Inc. (a subsidiary of Teva Pharmaceuticals), is aimed at relieving the effects of acute migraines in adults. Unlike other migraine medications, Zecuity is an 8-inch by 4-inch, battery-powered skin patch; it’s wrapped around a person’s upper arm or thigh, and works by administering a generic, migraine-specific painkiller, sumatriptan, through a mild electrical current that penetrates the skin and enters the bloodstream. The dose of sumatriptan is delivered over the course of 4 hours.

The device may sound good in theory, but now the Food and Drug Administration (FDA) is investigating whether or not Zecuity poses larger risks than originally thought.

Can the Zecuity® Patch System Cause Harm?

Originally approved by the Food and Drug Administration (FDA) in 2013, and subsequently allowed to market in September 2015, in Zecuity’s short 9 months, the device has racked up a large number of complaints from patients who say the medical device harmed them, by causing them severe redness, pain, skin discoloration, blistering, and cracked skin. According to the FDA’s safety announcement (issued June 2nd), these adverse effects occurred right at the site where the patch was worn.

The FDA is now further investigating the risk of serious burns and potential permanent scarring, as well as the possible extent of these adverse effects and their causes. While the FDA’s safety communication does say “a large number of patients have experienced burns or scars where the patch was worn,” their communication does not specify exactly how many people have been allegedly harmed at this point.

Be Safe: Know What You Are Putting on Your Body

It’s no secret that mind-busting migraines can prove hugely disruptive to people’s everyday lives. They limit productivity, force people into rest, and, worst of all, they can take hours – or sometimes even days – to fully subside. Certain painkillers can help with the symptoms of migraines, but often these, too, have limited effects.

However, it is important to be cautious when choosing any means of medication to lessen the symptoms of migraines or any other neurological disease. Sometimes, a new drug or device may seem too good to be true, and, as the FDA safety alert demonstrates, that may be the case with the Zecuity migraine patch. The FDA will continue its investigation into the safeness of Zecuity, and will update the public immediately if any additional regulatory action is required.

In the meantime, regulators warn those who experience moderate to severe pain to stop using the patch immediately and to contact their healthcare professionals.

Sokolove Law Team

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Last modified: December 28, 2016