Zecuity Patch Recall Shows Hazards of Approving Medical Devices Too Fast: ISMP

According to a recent report published by a drug safety watchdog, the Zecuity migraine patch recall announced earlier this year highlights the problem with rushing new drugs and drug delivery systems to the market. 

In June, Teva Pharmaceuticals sent out “Dear Health Care Provider” letter, announcing that it was suspending sales of the Zecuity migraine patch and recalling it at the pharmacy level, following many reports of patients suffering burns, blisters, and scars as a result of using the battery-powered drug delivery system.

This month, the Institute for Safe Medication Practices (ISMP) released its QuarterWatch report, calling the recall an example of what happens when new drug products are rushed to the market too fast, without proper vetting by the manufacturer or the FDA.

Zecuity (sumatriptan) was a battery-powered transdermal patch sold by Teva Pharmaceuticals, which was just approved by the FDA in September 2015, for the treatment of migraine headaches. The patch was designed to be worn on the arm or thigh for four hours and then discarded.

The FDA launched a safety review into the potential skin problems with Zecuity patch after identifying what it described as a “large number” of reports, which the agency has classified as serious adverse events. The agency did not specify how many incidents had been reported, and indicated that it will provide more information when the FDA review is complete and it decides whether additional regulatory action is necessary.

Teva announced its pharmacy-level recall just days after the safety review was announced.

The ISMP report notes that before it was launched under the brand name Zecuity, the battery-powered migraine patch was originally developed by a small Philadelphia biotech startup company called NuPathe, which submitted its design to the FDA for approval in October 2010. The FDA rejected it after a 10 month review, due to multiple concerns, including the risk of microbial contamination. However, the ISMP report found that FDA reviewers specifically mentioned a now-familiar problem.

“We have serious concerns about the potential of your product to cause severe burns and permanent skin lesions,” ISMP reports that FDA reviewers warned.

Fast-forward to 2015, and the migraine patch was approved after being redesigned, based on two small trials that involved a total of less than 60 test subjects combined. However, instead of requiring more safety trials before the patch hit the market, Teva Pharmaceuticals was permitted to move forward with marketing, while conducting surveillance studies looking at use of the drug in the real world.

“Instead of asking for more clinical testing, the agency required enhanced postmarket surveillance of the early patients who were unwittingly becoming test subjects to answer a specific scientific question that had been left on the table at drug approval. What kind of scars, burns, device leaks, erythema, and pruritus were going to occur with the redesigned device?” the ISMP report states. “Instead of more testing, the agency required the sponsor to report immediately (within 15 days) any device problems it learned about from early consumers.”

After just six months on the market, the Zecuity patch problems were reported on behalf of at least 389 individuals, including 117 reports of application site burns, 125 reports of application site pain, 63 adverse event reports of battery problems, and 59 reports of device leakage.

The ISMP notes that with a large drug product release, involving millions of consumers, those numbers may seem insignificant. However, in the first six months Zecuity was on the market, there were only 7,235 prescriptions dispensed.

The report also criticized the FDA for how it handled the recall, allowing the company to call it a suspension of sales and marketing instead of a recall; forgoing even the previous mild use of the term “safety withdrawal.” The ISMP noted that the FDA has not publicly announced a drug safety withdrawal in several years, even though it has removed drugs from the market due to safety problems.