The Food and Drug Administration accused a medical company of failing to investigate “hundreds of complaints that” the anti-allergy EpiPen device has misfired “during life-threatening emergencies,” including some cases in which people later died.
That stunning revelation is contained in a damning warning letter the FDA sent to the division of drug giant Pfizer, which makes EpiPens for another pharmaceuticals behemoth, Mylan.
The letter cites multiple “significant” regulatory violations related to the manufacturing of EpiPen discovered during inspections during February and March this year at a Missouri facility operated by Meridian Medical Technologies, the Pfizer-owned company.
It is the same facility that produced EpiPen lots which were subject to a recall earlier this year after two reports of the auto-injector devices misfiring. At the end of that recall, which is mentioned in the FDA letter, there were no public reports of deaths associated with EpiPens.
EpiPens are used to deliver a dose of the drug epinephrine to people who are suffering a potentially fatal allergic reaction known as anaphylaxis.
Mylan is the leading seller, by far, of auto-injectors containing epinephrine.
The FDA’s letter dated Tuesday to Meridian noted that “patients can died or suffer serious illness” if the EpiPen injectors do not operate as expected, or do not deliver the intended dose of epinephrine.
Despite that, the FDA charged, “you failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness.”
“Your own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died,” the letter said.
Many of those complaints involved failures of EpiPen to activate when a user followed instructions for the device, the FDA said.
There were also complaints that the EpiPens had “spontaneously dispensed epinephrine drug prior to use so that the drug was no longer available when the user attempted to activate the product,” according to the letter.
The FDA ordered Pfizer’s unit to correct the violations promptly. The agency’s letter also says failure to do so may result in legal action including seizure and injunction.
When asked for comment, a Pfizer spokeswoman told CNBC, “Patient safety is of primary importance to Pfizer.”
“We stand behind the quality, safety and efficacy of the products we manufacture,” the spokeswoman said. “We will continue to work with the FDA to resolve the points raised in the letter.”
A spokeswoman for Mylan had no immediate comment.