Earlier this fall, the FDA issued a warning to Mylan, the makers of EpiPens. In a scathing letter, the FDA highlighted manufacturing defects as well as Mylan’s failure to conduct adequate internal reviews after receiving many complaints about the life-saving device, EpiPen’s malfunctions. To date, there have been 7 deaths, 35 hospitalizations and 228 complaints about EpiPen and EpiPen Jr. devices this year. [See F.D.A Accuses EpiPen Maker of Failing to Investigate Malfunctions, New York Times, Sept. 7, 2017]
Following an FDA inspection of the manufacturing plant, FDA’s letter to Mylan describes EpiPens that were leaking epinephrine and others that malfunctioned. In March of this year, Mylan issued a recall of a small batch of EpiPen and EpiPen Jr devices.
While it is difficult to connect these defects to the deaths reported, as anaphylaxis itself can be deadly even with properly receiving epinephrine, these reports are not encouraging.
In February of this year, we had a frightening experience. [Please read the full story, The Fire Drill- 5 Key Lessons from an Intensely Scary Night.] Not long after eating at a restaurant, my 12 year old, food allergic son was rushed home, wheezing severely and coughing. He was so weak and nauseous that he could barely stumble to the bathroom. As I asked him questions, trying to evaluate the situation, it was becoming increasingly impossible for him to speak at all. I wheeled around to grab my EpiPens just steps from where my son sat. When I turned back around, he was blue.
This is every parent’s worst nightmare. It was certainly mine. Amidst the chaos of an increasingly critical and deteriorating situation, my only saving grace was that I held in my hand an EpiPen that would contain the correct amount of the life-saving drug, epinephrine and deliver it safely.
I can’t imagine being in that same moment now, knowing that the EpiPen in my hand may or may not save my son’s life. That it may or may not have the right dose of medicine. That the needle may or may not misfire. Would the knowledge of EpiPen defects cause you to hesitate? Would you instead call an ambulance that would take even more time to arrive? When minutes matter, these short hesitations in action, improper delivery of medication, and any other complications that arise during anaphylaxis could be costly…. even deadly.
Bear in mind, Mylan has also increased the cost of EpiPen from $50 in 2008 to over $600 currently. And, while the high cost of EpiPens are prohibitive, parents are still buying them, and they’re paying for one thing: reassurance. They pay for the firm knowledge that this product administers the correct amount of medicine properly every time. If that can’t be demonstrated, there are plenty of other auto-injectors on the market with a proven track record of reliability to consider.
Despite these less-than-comforting reports, please continue to carry and use your EpiPens and other auto-injectors. According to the FDA in a recent Bloomberg article, “We are not aware of defective EpiPens currently on the market and recommend that consumers use their prescribed epinephrine auto injector. We have seen circumstances in which adverse events reports increase once a safety issue is publicized, like a recall. We continue to monitor and investigate the adverse event reports we receive.”
I plan to keep you all informed as we continue to follow this story.
To read more on this story, please see EpiPen Failures Cited in Seven Deaths This Year, FDA Files Show posted on Bloomberg, Nov. 2, 2017.