FDA confirms EpiPen shortage in United States

FDA added EpiPen, EpiPen Jr, and the generic versions of those products from the maker Mylan to its list of drugs currently in shortage. FDA called it an intermittent supply chain shortage due to delays from Pfizer, Mylan’s manufacturing partner. The American Society of Health-System Pharmacists added EpiPen to its list of drugs in short supply in the United States a week before FDA’s announcement.

The issue was brought to regulators' attention originally when allergy advocacy groups, including the Food Allergy Research and Education, found that more than 400 people in 45 states indicated that they had trouble getting prescriptions filled for these epinephrine autoinjectors.

An FDA spokesperson said pharmacists and patients can contact Mylan directly (800-RXMYLAN/1-800-796- 9526) to locate EpiPens if they are experiencing any difficulties with supply.

It’s uncertain if the manufacturing issues at the Pfizer plant, Meridian Medical Technologies in St. Louis, MO, are related to a voluntary recall of select lots of EpiPen and EpiPen Jr produced at this site between December 2015 and July 2016. The recall is a result of reports of a defect in device activation.

In addition epinephrine autoinjector products from Impax Laboratories are currently in shortage, according to FDA. However, another epinephrine autoinjector manufacturer, Kaleo, reports that its AUVI-Q pens are available.

More information can be found on FDA’s website at https://apha.us/FDADrugShortages.