FDA: EpiPen failures cited in 7 deaths this year

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-wracking 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 has been cited in seven deaths this year through midSeptember, according to reports by patients and physicians made to the Food and Drug Administration and obtained by Bloomberg News. The FDA received 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.

Until now, the medical device has been the subject of controversy for a different reason. EpiPen is sold by Mylan NV, a drugmaker legally based in the Netherlands but run from Pennsylvania, that was under fire last year for significantly raising the price of the allergy shot, from about $50 for a single pen to more than $600 for a two-pack. Congress held hearings, government agencies began inquiries and rival Sanofi sued. The Paris-based competitor claimed Mylan sought “to preserve the monopoly position of their $1 billion crown jewel” by engaging in anticompetitive conduct. Mylan has denied any wrongdoing.

EpiPen and EpiPen Jr. failures resulted in a recall of some units in March by the company that makes the device for Mylan, Pfizer’s Meridian Medical Technologies. Mylan, which sells the drug-device combo using Meridian’s “pens,” called the defect “extremely rare.”

Reports submitted by users to the FDA, however, show broadening accounts of malfunctions dating as far back as 2014.

In 2012 there were four reports of EpiPen and EpiPen Jr. failures to the FDA, followed by 12 in 2013, according to an agency database. In 2014, those reports jumped more than 400 percent, to 67, according to the reports obtained by Bloomberg News.

It’s important to note that socalled adverse event complaints don’t confirm that a product caused the incident. At the same time, such reports typically don’t depict the full extent of a problem, given that most people aren’t aware they can submit them in the first place.

Pfizer has said consumer complaints aren’t unusual when a product “is frequently administered by non-medically trained individuals.” In an emailed statement Tuesday, the company said it’s “confident in the quality, safety and efficacy of EpiPens manufactured by” its Meridian subsidiary. Pfizer noted, however, that “in the case of EpiPen, adverse events can also be due to epinephrine itself, for a variety of reasons as reflected in the product label.”