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.
More articles on supply chain:
FDA hires Mylan exec as senior communications adviser
Pharma’s lobbying efforts: 10 drugmakers that spent the most so far in 2017
Analysis: Biosimilar drugs could cut US healthcare spending by $54B
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
