DRUG SHORTAGES

EpiPen Shortage: FDA Announces Additional Steps to Mitigate Shortage

August 21, 2018

The FDA has announced additional steps to mitigate the current EpiPen (epinephrine) auto-injector shortage. According to an agency press release, the FDA has extended the expiration dates for specific lots of 0.3 milligram products marketed by Mylan. The FDA has extended the expiration by four months beyond the labeled expiration date.

“Many patients rely on self-injectable epinephrine products, such as EpiPen, to reverse life-threatening reactions to bee stings or other allergens for either themselves or for their children,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press statement. “We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season.”

The decision to extend the use of certain lots beyond the approved 20-month shelf life was based on stability data provided by Mylan and reviewed by the FDA.

A complete list of the specific lots that have extended use dates can be found on the FDA website.

“We’ve completed the necessary reviews of the data to extend the expiration date by four months for specific lots of EpiPen that are expired or close to expiring,” Dr Woodcock explained. “We’re hopeful this action will ensure patients have access to this important medication and provide additional peace-of-mind to parents as the agency works with the manufacturer to increase supply.”

Although EpiPen is currently available, multiple factors, including regional supply disruptions and manufacturer issues, have contributed to EpiPen’s limited availability in certain areas across the nation. The FDA is continually working with Mylan on the production and supply of EpiPen. The FDA has also been in contact with other manufacturers of epinephrine auto-injectors, including Adrenaclick and Auvi-Q, regarding their supply as the school year begins—this time has historically been accompanied by increased product demand. Further, the first generic version of EpiPen has also been recently approved.

“The FDA remains committed to using all of the tools available to help prevent and mitigate drug shortages of medically necessary products used to prevent or treat a serious or life-threatening disease or medical condition,” Dr Woodcock concluded.

Julie Gould


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