Problems with some EpiPen and EpiPen Jr. Auto-Injectors may cause the devices to jam, potentially delaying or preventing live-saving drugs during cases of anaphylactic shock, federal drug regulators and the manufacturers warn.
On November 1, Mylan and it’s parent company, Pfizer, issued a Dear Healthcare Provider letter (PDF), warning about reports that some EpiPen and EpiPen Jr. Auto-Injectors, and their generic equivalents, jammed in their carrier tube.
As part of its own warning about the EpiPen problems, the FDA indicated it is aware of the risk, but is unaware of any adverse event reports associated with the jammed auto-injectors.
The letter from Mylan indicates that in a small number of cases, the labels of the auto-injectors did not fully adhere to the surface, resulting in the device label becoming stuck inside its carrier tube. This can lead to the failure to administer the drug and a patient’s progression to a more severe allergic reaction.
The letter indicates the problem affects some EpiPen 0.3 mg with NDC 49502-500-02 and the Authorized Generic with NDC 49502-102-02, both with expiration dates between June 2018 and February 2020. The problem can also affect EpiPen Jr. 0.15 mg with NDC 49502-501-02 and the Authorized Generic with NDC 49502-101-02, both with expiration dates between October 2018 and October 2019.
Mylan’s letter gives detailed instructions on how to ensure the auto-injectors do not become jammed when needed. The letter claims the cause of the problem has been identified and preventative actions are in place to avoid similar problems in the future. The letter also indicates that the problem is only expected to affect about one auto-injector out of every 14,287.
The letter comes about a year after a report about a growing number of EpiPen problems and failures was published by Bloomberg News, indicating that there had been at least 228 reports as of November 2017, with at least seven deaths and 35 hospitalizations associated with use of EpiPen products.
The report was based on data obtained through the use of a Freedom of Information Act (FOIA) request, which Bloomberg News indicated shows a steady rise in the number of problems with EpiPens over the last five years. While there were just four reports of EpiPen failures in 2012, and 12 reports in 2013, 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 2017, 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.
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 2017, 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 anti-competitive 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.
Customers with questions about these latest EpiPen Auto-Injector jamming problems may contact Mylan Customer Relations at 1-800-796-9526. Adverse events and reactions can be reported to Mylan by calling 1-877-446-2679. The FDA also requests that any problems experienced also be reported to its MedWatch Adverse Event Reporting Program.