EpiPens have been in the news lately, and not for their life-saving properties. From accusations of price gouging to a recall in Singapore over concerns regarding defects, the device has been getting a lot of flak over improprieties and more. Now, there’s more potentially bad press on the horizon as the Federal Drug Administration (FDA) has accused Pfizer, which manufactures the product for the drugmaker Mylan, of failing to properly investigate accusations of malfunctioning EpiPens, according to a recent story by the New York Times.
According to the FDA, a unit of Pfizer named Meridian Medical Technologies did not properly examine alleged problems with a component EpiPen device, even after numerous complaints surfaced. The problem in question has to do with a part of the device that actually fires and shoots a proper dose of epinephrine, rendering it useless in a life-threatening situation.
“Hundreds of complaints”
Epinephrine is typically used to treat allergic reactions in order to prevent anaphylaxis, a potentially deadly reaction which has serious respiratory and cardiovascular symptoms. The FDA claims that Pfizer received hundreds of complaints regarding non-working EpiPens, including in situations in which patients died from the allergic reaction, yet never properly investigated the alleged problems.
Earlier in the year, Pfizer and Mylan recalled 13 lots of the product for the same issue after increased pressure and continued discussions with the FDA.
For their parts, Pfizer and Mylan claim that it’s not unusual to receive product complains, yet they currently have no evidence of a connection between these complains and any allegations of a patient’s death.
In accusing Pfizer, the FDA sent a warning letter, hoping to motivate the drug maker into investigating the product and making necessary, even life-saving changes.
Dealing with a defective EpiPen
It can be difficult to gauge the efficacy of the EpiPen until it’s too late, which is why these allegations are particularly troubling for individuals with known allergies who rely on the EpiPen as a failsafe measure.
For people that rely on medical devices to continue living, even a rare defect can be threatening. EpiPen users are urged to carry at least two devices at any time, and should stay up to date with recalls and expiration dates.