The U.S. Food and Drug Administration told EpiPen’s maker, Pfizer Inc., this week that it failed to properly investigate reports of malfunctioning auto-injectors, including incidents associated with patient deaths and severe illnesses.
The FDA’s Sept. 5 warning letter to Pfizer’s Meridian Medical Technologies unit includes new details surrounding a global recall of EpiPens in March.
Tens of thousands of EpiPens, sold by Mylan NV, were recalled worldwide in March after two reports of the life-saving shot failing to work in emergencies.
“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 U.S. regulator wrote.
The letter outlines the FDA’s inspection of Meridian’s manufacturing facility in Brentwood, Mo.
Christina Antoniou, senior manager of corporate affairs for Pfizer Canada, said the manufacturing facility supplies all EpiPens.
The FDA letter says the company failed to investigate problems with the devices, recall batches and act on problems, including expanding its internal investigation after two customer complaints of EpiPen failures were traced to a deformed component.
Pfizer makes EpiPens for Mylan, which has come under fire for sharply hiking the price of the device in the U.S.
“Between 2015 and now, we have shipped more than 30 million EpiPen Auto-Injectors globally. It’s not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals,” Pfizer said in an emailed statement.
“We currently have no information to indicate that there was any causal connection between these product complaints and any patient deaths.”
In an emailed statement, Mylan said: “Pfizer’s recall several months ago of certain lots of EpiPen Auto-Injector was taken as a proactive and precautionary measure with FDA in relation to these issues.”
Both Mylan and Pfizer said they are confident in the safety and efficacy of EpiPen products being produced at the site.
Mylan said it does not currently anticipate any supply issues as a result of the warning letter.
The EpiPen is used to treat allergic reactions to certain food and bug bites.
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