failure to launch
The FDA received 4 complaints of EpiPen failure in 2012. There have been 228 complaints and seven deaths this year.
The U.S. Food and Drug Administration has received 228 reports of EpiPen or EpiPen Jr. failures this year, resulting in seven deaths and 35 hospitalizations, Bloomberg News reports. The data, collected through mid-September, dwarfs that of years past: The FDA received only four reports of EpiPen and EpiPen Jr. failures in 2012 and just 12 in 2013, but there has been a 400 percent increase in failures since 2014, when the FDA received 67 complaints.
EpiPen products are sold by Mylan NV and made by Pfizer Inc.'s Meridian Medical Technologies. Pfizer has previously claimed that because "non-medically trained individuals" like parents or teachers are frequently administering EpiPens, consumer complaints about the use of their product were not unusual. The FDA also noted in a statement to Bloomberg that product complaints do not necessarily mean that the product itself was to blame if it did not work properly.
In September, however, the FDA sent a warning letter to Meridian Medical Technologies reporting that epinephrine — the hormone dispensed by EpiPens, which treats life-threatening allergic reactions — had in fact leaked out of certain pens and that in some cases, the devices' auto-injectors had failed to work. One woman told Bloomberg that in 2014, she had to take her son to the hospital after she was unsure if her EpiPen's auto-injector had worked properly.
Bloomberg also noted that these complaints may not paint a complete picture of the problem, given many people do not know that they can send complaints to the FDA. Mylan NV has also recently come under fire for significantly raising the price of the life-saving product.
It is estimated that nearly 4 million EpiPens were prescribed last year. Read more on the FDA's findings at Bloomberg.