PITTSBURGH _ The U.S. Food and Drug Administration has issued a warning letter to the maker of Mylan's EpiPen emergency allergy shot after concluding the manufacturer failed to properly investigate "hundreds" of complaints about the device failing.
The warning letter, dated Sept. 5, was sent to Pfizer Inc.'s Meridian Medical Technologies division. The letter accuses Meridian of failing to thoroughly investigate "serious component and product failures ... including failures associated with patient deaths and severe illness."
Many of the complaints involved activation failures when the user followed the operating instructions, the FDA said, as well as devices that spontaneously dispensed epinephrine prior to use so that the drug wasn't available when the user needed it.
Meridian failed to recall some EpiPens from the market until after an FDA inspection, the letter said.
The agency inspected Meridian's manufacturing plant in Brentwood, Mo., from Feb. 20 to March 24 this year, according to the letter.
The letter warned Meridian to take corrective actions, including fixing how it handles and investigates complaints, or it could face legal action and seizure of products.
Pfizer, based in New York, issued a statement Thursday saying, "Patient safety is of primary importance to Pfizer."
"We stand behind the quality, safety and efficacy of the products we manufacture. We will continue to work with the FDA to resolve the points raised in the letter."
Mylan, which sells the EpiPen and has its administrative offices in suburban Pittsburgh, issued a statement saying it "has an unwavering commitment to quality and patient safety" and was "confident in the safety and efficacy of EpiPen products being produced at the site."
"Mylan will do whatever it can to support" Pfizer and the FDA in resolving points raised in the warning letter, the statement said.
"We note that 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."
