EpiPen failures — specifically their inability to deploy correctly — were linked to seven patient deaths so far this year, according to FDA reports obtained by Bloomberg.
Between January and September this year, the FDA received 228 reports of EpiPen or EpiPen Jr. malfunctions, which is more than double the number of reported failures in 2016.
Although the FDA reports do not outline how the EpiPen malfunctioned in the circumstances that didn't result in death, in September the FDA sent a warning letter to Meridian Medical Technologies, a Pfizer subsidiary that manufacturers EpiPens for Mylan, detailing some of the complaints.
The deficiencies included circumstances where EpiPens failed to activate or spontaneously leaked epinephrine prior to activation. Following the complaints, Meridian issued a worldwide recall of 81,000 EpiPens.
Editor's note: This article was updated Nov. 11 at 3:44 p.m. to clarify there is not a causal relationship between the patient deaths and EpiPen malfunctions.