Nov 3, 2017

Reports of EpiPen failures spike

Photo: Rich Pedroncelli / AP

At the same time the price of the EpiPen has soared, so have reports of malfunctions, according to a Bloomberg News analysis of data from the Food and Drug Administration.

Why it matters: "This is a lifesaving product," Diana Zuckerman, president of the National Center for Health Research, told Bloomberg. "If it fails 105 times, that's significant."

The details:

  • The FDA has received 228 reports of EpiPen failures so far this year — up from 105 last year, up from just four in 2012.
  • Of those 228 reported failures this year, 35 people were hospitalized and seven were tied to patients' deaths, according to Bloomberg.
  • The product's design changed in 2009. Mylan, the company that sells the EpiPen, told Bloomberg those changes were important for patient safety. They also extended Mylan's patent protections.

Correction: This post has been updated in the last paragraph to clarify that the EpiPen redesign was in 2009.

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