Meridian Medical Technology recently issued a voluntary recall of several lots of the Mylan EpiPen and EpiPen Jr. These are the auto-injectors used to deliver epinephrine quickly in the event of anaphylactic shock, a deadly reaction to an allergen. The recall was issued over the fact that the devices may have a defective part in them, which would cause them to fail to activate and deliver the medication.
EpiPen and Anaphylaxis
The EpiPen is a device that delivers one dose of epinephrine in the event of a severe allergic reaction. Allergies to things like nuts or bee stings can cause mild reactions in some people, but more severe reactions in others. The severe reaction is called anaphylaxis, or anaphylactic shock. It is characterized by swelling in the face, mouth, and throat, and if not treated immediately can be fatal. EpiPens and other epinephrine auto-injectors are life-saving devices. If one fails to work, it could cost someone their life.
The Mylan Recall
Mylan’s EpiPens were first recalled in Australia. That recall included 80,000 of the devices and was issued in response to two incidents in which the devices were difficult to activate. Mylan issued the recall and a press release explaining that there was a chance that a component in the devices was defective. The devices that did have the faulty component were either difficult or impossible to activate. The recall was then extended to the U.S. and affected those devise that were distributed from between December 17, 2015 and January 2016.
Although the recall was voluntary, the U.S. Food and Drug Administration (FDA) also issued a statement regarding the recall. The FDA listed the 13 lot numbers that are included in the recall. These are EpiPens and EpiPen Jr devices that have expiration dates of April, May, September, and October 2017. The FDA has also warned consumers and those who carry EpiPens not to throw out the affected devices until they receive a replacement. The FDA also reminded consumers that even after using an EpiPen successfully, it is important to get emergency medical care.
Mylan’s Continuing Controversy
This recall is just the latest in a string of controversies for the Mylan EpiPens. In 2007 the devices cost $47, but by 2016 Mylan had raised that price to a whopping $284. Because an EpiPen prescription is only filled with two devices, people were being expected to pay $634 to get their life-saving devices. Mylan finally introduced a generic version that cost just $300 for a pair, but only after receiving thousands of complaints and fielding bad press over the soaring cost.
Mylan was also accused of overcharging the government for EpiPens for Medicaid patients by misclassifying them. The U.S. Department of Justice settled with Mylan which was forced to pay $465 million for overcharging Medicaid.
The controversies seem to be never-ending for Mylan, but so far the defective part causing some of the EpiPens to be recalled has not led to any fatalities. Anyone with an EpiPen that is part of the current recall is urged to get a replacement and to hold on to the recalled device until the new one arrives.