EpiPen Failures Cited in Seven Deaths This Year, FDA Files Show

This article was distributed by Bloomberg news service and was published in newspapers across the country, including the Washington Post, Charleston Gazette-Mail, and MedPage Today.

Paulette saw it happen at the playground from several feet away, the panic-inducing moment in 2014 when her 3-year-old son Charlie, who has a life-threatening allergy to milk, grabbed a playmate’s sippy cup and took a gulp.

Thankfully, Paulette had the anaphylaxis-stopping EpiPen and was able to quickly use the auto-injector on her son. But when she pulled the needle from his thigh, it was sticking out of the device at an angle instead of being under an orange cover, leaving her unsure whether the lifesaving medicine had been administered. Not wanting to take a chance, Paulette (who requested anonymity to protect her son’s identity) called 911, and Charlie was rushed to a hospital where he remained for several hours until doctors were sure he was all right.

“He was OK, but it was nerve-racking to say the least, not knowing if the EpiPen had worked or not,” she said.

Not everyone has been as lucky as Charlie.

EpiPens, which contain the hormone epinephrine (also known as adrenaline), are used to stave off allergic reactions that can in some cases kill. Failure of EpiPens to deploy correctly have been cited in seven deaths this year through mid-September, according to reports by patients and physicians made to the U.S. Food and Drug Administration and obtained by Bloomberg News. The FDA received a total of 228 reports of EpiPen or EpiPen Jr. failures during the same time period, according to documents made available as a result of a Freedom of Information Act request. In addition to the deaths, 35 people were hospitalized, according to the reports. […]

Although the reports provided by the FDA don’t explain how the EpiPens failed, FDA investigators who inspected Meridian’s Missouri plant earlier this year said in a warning letter sent in September that epinephrine had in some cases leaked out of the pens. In other cases, the injectors didn’t work properly, the regulator said.

“We are not aware of defective EpiPens currently on the market and recommend that consumers use their prescribed epinephrine auto injector,” the FDA said in an emailed statement Tuesday. “We have seen circumstances in which adverse events reports increase once a safety issue is publicized, like a recall. We continue to monitor and investigate the adverse event reports we receive.” […]

In its warning letter, the FDA noted that Meridian staff had said the company initiated a recall of some EpiPens only after government prodding. The agency said inspectors found the device maker had “failed to thoroughly investigate multiple serious component and product failures” for EpiPen products, “including failures associated with patient deaths and severe illness.” The FDA at the time didn’t specify how many were hurt or had died.

But even before the recall, which often boosts reports as word spreads, the FDA received 105 complaints of EpiPen failures in 2016.

“This is a lifesaving product,” Diana Zuckerman, president of the National Center for Health Research, said in an interview. “If it fails 105 times, that’s significant.” […]

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