Not only is a pack of EpiPens expensive, they may also be increasingly hard to get your hands on due to the ongoing shortage. But, according to an announcement from the FDA this week, the epinephrine auto-injectors used in severe allergic reactions are actually totally fine to use for a few months after their expiration date.
The hope is that extending this time window will ease the EpiPen shortage. “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, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a statement. "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." (Two-packs of 0.3 mg and 0.15 mg EpiPen injectors were added to the FDA's list of drug shortages back in May, the reason being manufacturing delays.)
It's important to note that this only applies to specific lots of 0.3 mg EpiPen injectors with original expiration dates between April and December 2018 (see the full list with specific batch numbers here). The updated expiration dates now run from August 2018 through February 2019. The FDA also extended expiration dates for Pfizer's authorized generic version of the EpiPen.
As SELF wrote previously, epinephrine is a life-saving tool in the event of a serious allergic reaction, and people with severe allergies are advised to keep it on-hand.
In particular, an epinephrine auto-injector is useful in the event that someone begins to go into anaphylaxis, an allergic reaction in which the airways swell up, making it difficult to breathe. They may also have other symptoms of an allergy, including a skin rash or hives, swelling of the face or lips, and a rapid pulse. Without rapid treatment, anaphylaxis can be deadly.
"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,” Dr. Woodcock's statement continued. “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.”
Related:
