Sign up United Kingdom
Proactive Investors - Run By Investors For Investors

FDA sends damning warning letter to Pfizer after misfiring EpiPens linked to deaths

US, Food and Drug Administration, Pfizer Inc, Mylan, EpiPen, anaphylactic shock, warning letter, Meridian Medical Technologies, pharma, drugs
Pfizer’s Meridian Medical Technologies division makes EpiPen devices for fellow drugs giant Mylan

The US Food and Drug Administration has sent a damning warning letter to drug giant Pfizer Inc (NYSE:PFE) after it received “hundreds of complaints” that the anti-allergy EpiPen device misfired “during life-threatening emergencies”.

The letter was sent to Meridian Medical technologies, the division of Pfizer that makes EpiPens for fellow pharma behemoth Mylan (NASDAQ:MYL).

It claimed that in some cases people had died after the device, which delivers a dose of epinephrine to people suffering from severe allergic reaction known as anaphylaxis, failed to work properly.

During an inspection at Meridian’s Missouri facility earlier this year, the FDA said it found multiple “significant” regulation violations related to the manufacturing of the device.

It is the same facility that produced a batch of EpiPens that was subject to a recall earlier this year after two reports of the auto-injectors misfiring.

“You failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness,” read the warning letter.

“You also failed to expand the scope of your investigations into these serious and life-threatening failures or take appropriate corrective actions, until FDA's inspection.”

It concluded: “Correct the violations cited in this letter promptly. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction.”

In a statement given to CNBC, Pfizer said: “We currently have no information to indicate that there was any causal connection between these product complaints and any patient deaths.

"We are very confident in the safety and efficacy of EpiPen products being produced at the site.”

Pfizer shares were broadly flat in pre-market trading at US$33.98, while Mylan’s stock was down 0.4% to US$31.91.

View full PFE profile View Profile

Pfizer Timeline

November 23 2015

Related Articles

March 19 2018
The group has received key permits to allow cannabis - flowers and oils - to be imported into Australia from Aurora Cannabis Inc
3d rendering of an antibody
July 24 2018
It is teaming up with Bach BioSciences, a company commercialising the research of William Bachovchin, a professor at Tufts University School of Medicine, Boston
Picture of growing facility
May 07 2018
Establishing a vertically integrated business model provides THC with the ability to optimise efficiencies in the manufacturing process.

No investment advice

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is suitable or advisable for any specific person. You further understand that none of the information providers or their affiliates will advise you personally concerning the nature, potential, advisability, value or suitability of any particular security, portfolio of securities, transaction, investment strategy, or other matter.

You understand that the Site may contain opinions from time to time with regard to securities mentioned in other products, including company related products, and that those opinions may be different from those obtained by using another product related to the Company. You understand and agree that contributors may write about securities in which they or their firms have a position, and that they may trade such securities for their own account. In cases where the position is held at the time of publication and such position is known to the Company, appropriate disclosure is made. However, you understand and agree that at the time of any transaction that you make, one or more contributors may have a position in the securities written about. You understand that price and other data is supplied by sources believed to be reliable, that the calculations herein are made using such data, and that neither such data nor such calculations are guaranteed by these sources, the Company, the information providers or any other person or entity, and may not be complete or accurate.

From time to time, reference may be made in our marketing materials to prior articles and opinions we have published. These references may be selective, may reference only a portion of an article or recommendation, and are likely not to be current. As markets change continuously, previously published information and data may not be current and should not be relied upon.

© Proactive Investors 2018

Proactive Investors Limited, trading as “Proactiveinvestors United Kingdom”, is Authorised and regulated by the Financial Conduct Authority.
Registered in England with Company Registration number 05639690. Group VAT registration number 872070825 FCA Registration number 559082. You can contact us here.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use