The U.S. Food and Drug Administration has accused a company of not investigating the hundreds of complaints received that EpiPen the anti-allergy device misfired during emergencies that can be life-threatening, including in cases in which the person later died.
The shocking revelation is in a warning letter that the FDA sent to a Pfizer division that makes the EpiPens for Mylan another pharmaceutical giant.
The letter cites several regulator violations that are related to the EpiPen manufacturing that were discovered during inspections made in February and March of 2017, at a facility in Missouri, which Meridian Medical Technologies a subsidiary of Pfizer, operates.
At the same facility producing the EpiPen, which earlier in the year had been recalled following a pair of reports of the misfiring of the auto-injector devices, when that recall ended, which is in the FDA letter, there were not any reports released to the public of any deaths associated with the use of the EpiPens.
EpiPens deliver doses of epinedrine to users who at the time are suffering a possibly fatal allergic reaction called anaphylaxis.
Mylan’s EpiPen leads in sales by a wide margin out of the auto-injectors that contain epinedrine. The letter from the FDA to Meridian indicated that patients can suffer severe illness or die, if the auto-injectors fail to operate as they should, or fail to deliver the correct dose of the drug.
The FDA added in the letter that the company failed to investigate thoroughly the multiple serious product and component failures for the EpiPens, including the failures that were associated with severe illness and deaths of patients.
The letter noted that the company’s own data shows it had received hundreds of complaints that the EpiPen products had failed to operate in emergencies that had been life-threatening, including situations where the user had subsequently died.
Several of the complaints received involved the failure of the EpiPen to activate even though the user followed the instructions, said the FDA letter.
From 2014 to 2015, Meridian records indicated that the company received 171 samples of EpiPens that were related to user complaints and had failed to activate even though the patient had followed the operational instructions properly.
The federal regulator agency noted Meridian has disassembled just a small fraction of the 171 samples received, and when asked why only a small quantity, a company official in quality control had told FDA inspectors it had been the policy not to disassemble the EpiPens unless management had approved.