FDA sends EpiPen maker a warning
The makers of the EpiPen failed to properly investigate more than 100 complaints that the device misfired during lifethreatening emergencies — including situations in which patients later died, according to a Food and Drug Administration letter.
In a warning letter, the FDA said Meridian Medical Technologies, a Pfizer company that manufactures the auto-injectors used to treat life-threatening allergic reactions, had detected faults in some units of the EpiPen and failed to adequately respond — “including some situations in which patients subsequently died.”
The September 5 warning letter noted that the manufacturers had received 171 complaints about products that failed to activate between 2014 and 2017, but did not disassemble “the vast majority” of the units as part of its investigation. The device is designed to inject epinephrine to halt dangerous allergic reactions.
“In fact, 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 FDA letter said. “Many of the complaints related to product activation failures, including failures to activate when the user followed the operating instructions, as well as failures for products that spontaneously dispensed epinephrine drug prior to use so that the drug was no longer available when the user attempted to activate the product.”
Meridian Medical Technologies discovered that a critical component of the autoinjector product failed last year, the FDA inspection which triggered the letter found.
The company rejected two lots of that component and asked the manufacturer of the part to do an investigation, but continued to make the drug -- without “linking the known component failure with numerous complaints you received regarding ‘failure to activate,’ ‘difficult to activate,’ or other product activation failures,” the letter said.
Meridian Medical Technologies recalled certain lots of the auto-injectors in March.
A Pfizer spokeswoman did not immediately respond to a request for comment or answer questions about patient deaths.
The FDA letter was sent to the Pfizer company, but the drug is marketed by Mylan, which has come under fire for the repeated price hikes it made to the price of EpiPen.
“We note that Pfizer’s recall several months ago of certain lots of EpiPen AutoInjector was taken as a proactive and precautionary measure with FDA in relation to these issues,” Mylan spokeswoman Nina Devlin said in an e-mail. “Mylan has an unwavering commitment to quality and patient safety and we are confident in the safety and efficacy of EpiPen products being produced at the site. Further, we do not currently anticipate any supply issues as a result of the warning letter.”