WASHINGTON -- The FDA will extend by 4 months the expiration date for of EpiPens as a way to help alleviate a shortage of the devices, the agency announced Tuesday.
"We've completed the necessary reviews of the data to extend the expiration date by 4 months for specific lots of EpiPen [sic] that are expired or close to expiring," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statement. "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."
The FDA of an EpiPen shortage on May 9th. At that time, Pfizer that "Meridian, a subsidiary of Pfizer that manufactures EpiPen auto-injectors, has experienced intermittent constraints affecting U.S. supply ... We are working tirelessly to increase production as rapidly as possible. We are currently shipping EpiPen, with production increasing over the last few months and anticipated to continue to increase and stabilize over the coming months."
Media outlets have reported that patients -- or parents of patients -- have been the epinephrine auto-injection device at their local pharmacy.
A small published last year found that EpiPens retained substantial epinephrine for years after their expiration dates, with more than half of pens tested containing at least 90% of their stated amount of adrenaline.
Researchers tested the potency of 40 expired EpiPen products (31 EpiPens and 9 EpiPen Jrs) collected from a single community clinic over a 2-week period. The pens had expired 1 to 50 months prior to analysis. The investigators found that 65% of EpiPens (1 mg/mL epinephrine) and 56% of EpiPen Jrs (0.5 mg/mL epinephrine) contained at least 90% of the stated amount of the drug.