FDA calls out EpiPen manufacturer for product flaws linked to patient deaths

Meridian Medical Technologies, a Pfizer subsidiary that manufacturers EpiPen's for Mylan, is in hot water for failing to adequately investigate complaints about the auto-injectors' efficacy, according to The Washington Post.

Here are six things to know.

  1. The Food and Drug Administration sent the manufacturer a warning letter Tuesday, which noted Meridian received 171 complaints between 2014 and 2017 about EpiPens failing to properly activate during emergency situations, "including some situations in which patients subsequently died."

  1. The complaints detailed EpiPens that failed to activate when the user followed operating instructions and others that spontaneously dispensed epinephrine prior to activation.

  1. Following the complaints, Meridian 22 issued a worldwide recall for 81,000 EpiPens March, which was expanded to the U.S. in early April.

  1. Pfizer said these complaints are fairly typical, "especially when the product is frequently administered by non-medically trained individuals," according to a statement cited by The Washington Post.

  1. In the warning letter, the FDA claimed Meridian's investigation into the complaints was not thorough enough and called out the manufacturer for not discovering the root cause of the malfunctions.

  1. The agency asked Meridian to conduct a comprehensive review of its investigations, develop a plan to promote patient safety and assess quality risks for EpiPens still in distribution.

More articles on supply chain:

Supply chain tip of the day: Consider seasonal indexes when demand planning
Hemophilia drug trial halted after patient death: 3 things to know
Novo Nordisk settles diabetes drug lawsuit for $58.7M: 3 things to know

© Copyright ASC COMMUNICATIONS 2019. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.

 

Top 40 Articles from the Past 6 Months