Federal health regulators have received an increasing number of adverse event reports in recent years involving EpiPen failures and problems, including a number of deaths, adding to existing concerns about the manufacturer’s recent decision to drastically increase the price of the life-saving drug.
According to a recent report by Bloomberg News, a Freedom of Information Act (FOIA) request revealed that there have been at least 228 reports of EpiPen problems already this year, with at least seven deaths and 35 hospitalizations that may be associated with failure of the emergency allergy auto-injectors.
That FOIA request shows a steady rise in the number of reports over the last five years, with just four reports of EpiPen failures in 2012, and 12 reports in 2013. However, the number jumped to 67 in 2014 and has continued to spike since then.
The injector pens provide a critical treatment for individuals with severe allergies or asthma attacks. Many individuals carry an EpiPen at all times to inject epinephrine, a chemical that narrows blood vessels and opens the airways to the lungs, in the event they are having a serious or life-threatening allergy or asthma attack.
The pens contain epinephrine, commonly referred to as adrenaline, a hormone that can reverse severe low blood pressure and increase the heart rate, muscle strength, blood pressure, and sugar metabolism. Treatment of epinephrine can also reverse wheezing, severe skin itching, hives and various other symptoms of an allergic reaction.
In September, the FDA sent a warning letter to Meridian Medical Technologies, which manufactures EpiPens that are distributed by Mylan. The letter indicated that FDA investigators discovered the manufacturer had failed to adequately investigate 171 sample pens sent back due to malfunctions between 2014 and 2017.
FDA and Mylan officials pointed out that because the FDA receives a report involving a particular drug or medical device does not mean that the device caused the injury reported. However, experts also note that the FDA probably only receives reports on about 10% of actual incidents, meaning the number of EpiPen malfunctions, injuries and deaths could be significantly higher.
Mylan officials insisted to Bloomberg that failures were rare and that EpiPens were safe.
The drug maker has been the subject of Congressional hearings, EpiPen lawsuits and public ridicule and derision since it sextupled the price of the epinephrine shots after purchasing the EpiPen brand in 2007. Critics claim that Mylan is price-gouging consumers by charging $600 for a pack of two EpiPens, which cost about $100 just 10 years ago.
In August, a number of EpiPen class action lawsuits were centralized for pretrial proceedings in the U.S. District Court for the District of Kansas as part of an MDL, or multidistrict litigation, under U.S. District Judge Daniel Crabtree. ALl of the lawsuits raise nearly identical allegations about anticompetitive conduct or unfair marketing practices associated with EpiPens. Most, if not all, of the complaints seek class action status to present claims for various groups of potential consumers who have used or need to use the injections, potentially impacting millions of Americans.