FDA Warns Manufacturer for Not Addressing EpiPen Problems — Physician’s First Watch

Medical News |
September 11, 2017

FDA Warns Manufacturer for Not Addressing EpiPen Problems

By Kelly Young

Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH

The FDA has notified Pfizer's Meridian Medical Technologies that it has not properly investigated hundreds of reported failures of its EpiPen auto-injectors.

Some of the failures have resulted in deaths and serious illness, the agency said in a warning letter to the company.

For instance, the company found a failing unit in part of the auto-injector, causing it not to fire. While they rejected that lot, they didn't determine whether other units were similarly defective, and they continued making EpiPens with these components.

The company did not properly identify the scope and frequency of the problem, the agency said, and their response to problems was inadequate.

Your Comment

(will not be published)

Filtered HTML

  • Allowed HTML tags: <a> <em> <strong> <cite> <blockquote> <code> <ul> <ol> <li> <dl> <dt> <dd>
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Do you have any conflict of interest to disclose?
CAPTCHA
This question is for testing whether you are a human visitor and to prevent automated spam submissions.

Vertical Tabs

* Required

Reader comments are intended to encourage lively discussion of clinical topics with your peers in the medical community. We ask that you keep your remarks to a reasonable length, and we reserve the right to withhold publication of remarks that do not meet this standard.

PRIVACY: We will not use your email address, submitted for a comment, for any other purpose nor sell, rent, or share your e-mail address with any third parties. Please see our Privacy Policy.