The FDA took steps Tuesday to mitigate the shortage of EpiPens by allowing some expired devices for treating life-threatening allergic reactions to remain on the market.
The FDA said that after reviewing data, it had decided it can extend the expiration date by four months for specific lots of EpiPens that are expired or close to expiring.
“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,” Janet Woodcock, CDER director for the FDA, 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,” she said.
Parents of children who need the pens in the event of a severe allergic reaction have been scrambling to find replacements in some markets. Spot shortages of Mylan’s EpiPens developed last year when a Pfizer subsidiary that makes them for Mylan had manufacturing delays. The FDA this May added it and the injectors from Impax Laboratories to its drug shortages list.
The agency also last week approved the first official generic of the EpiPen from Teva, but that product won’t be available to consumers for some weeks.
The agency said it is extending the expiration date of specific lots of 0.3-mg products from Mylan by four months beyond the labeled expiration date. That is beyond the approved 20-month shelf life. The FDA emphasized that the products should have been, and should continue to be, stored as labeled.
The affected lots have current expiration dates between April 2018 and December 2018. The new expiration dates can be found on the FDA's website. Pfizer, which makes the autoinjectors for Mylan, said in a statement that the extension of expiration dates does not apply to EpiPen Jr 0.15-mg autoinjectors or its authorized generic version of that strength.
Pfizer acknowledged that Meridian, the Pfizer subsidiary that manufactures the pens, continues to have "manufacturing constraints," but said it is working with Mylan to improve "consistent availability." Spot shortages of the injectors began last year after an FDA inspection found serious problems at the plant where they are made and which the FDA laid out in a warning letter.
Pfizer said, "Patients should have confidence in using the products from these particular lots as Pfizer works to stabilize supply, which is anticipated in the fourth quarter of 2018," Pfizer said.