EpiPen Maker Failed to Investigate Product Flaws Associated with Patient Deaths, FDA Says

The makers of the EpiPen failed to properly investigate more than 100 complaints that the device malfunctioned during life-threatening emergencies — including situations in which patients later died, according to a Food and Drug Administration warning letter sent to a Pfizer company.

The FDA said in the letter that 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 had failed to adequately respond.

The Tuesday warning letter noted that the manufacturer 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. The product flaws included the device not functioning properly when needed and the injector not having drug left when needed.

“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,” the letter said. […]

Diana Zuckerman, president of the National Center for Health Research, said that the strongly worded letter was unusually blunt and straightforward, and will raise concerns for parents and patients who depend on the EpiPen.

“It may well be a very small number, relatively speaking, of EpiPens that are likely to be problematic, and it may be that those have been recalled. But the parents and patients don’t know that,” Zuckerman said. “This is a product where you don’t know, until you use it, whether it works or not. I think it’s safe to say no patient — and no parent — wants to find out the hard way that the product that they have isn’t effective.” […]

Read the original article here.