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Seven deaths attributed to EpiPen failures this year, FDA files show

By in Press Enterprise on November 3, 2017

By Bloomberg

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.

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 […]    

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