Periodic shortages of epi across the U.S. that have occurred as a result of manufacturing, supply and delivery issues. Due to these shortages, the U.S. Food and Drug Administration (FDA) has extended expiration dates for specific lots of medication.
Due to the intermittent supply interruptions of EpiPen, FDA is alerting health care professionals and patients of updated dates through which some EpiPens and the authorized generic version, manufactured by Meridian Medical Technologies, a Pfizer company, may be used beyond the manufacturer’s labeled expiration date. To help ensure patient safety, these products should have been — and should continue to be — stored as labeled.
“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. We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season. 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. 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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.” FDA News Brief, August 21.
Go to the FDA website for the latest list of extended use dates from Pfizer.
EpiPen refers to the brand name version of an epinephrine auto-injector; it’s an injection that contains epinephrine. The pen is a quick self-injection system that can be used by anyone to deliver medicine to someone in allergic shock.
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