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FDA extends EpiPen expiration dates to cover shortages

Some EpiPens may be stable for four months beyond their expiration date, the FDA said.
The EpiPen.Rich Pedroncelli / AP file

The Food and Drug Administration said Tuesday that people can use some expired EpiPens for a few months longer, to help cover spot shortages that have put some parents into a panic at the beginning of a new school year.

Certain batches of the devices, which inject lifesaving medication to stop severe allergic reactions, can be used for four months beyond their expiration, the FDA said.

“We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season,” the FDA’s Dr. Janet Woodcock said in a statement.

“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,” she added.

“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 affected devices hold the 0.3-milligram dose, the FDA said. The agency said it reviewed data from Mylan, which sells EpiPen, showing that the product is still effective beyond the expiration date.

“While product is currently available, multiple factors, including regional supply disruptions and manufacturer issues, have contributed to EpiPen’s limited availability in certain areas in the U.S.,” the FDA said.

The auto-injector devices are designed to make it quick and easy for patients to deliver a dose of epinephrine to stop a life-threatening allergic attack called anaphylaxis. People can go into anaphylactic shock after eating a food they’re very allergic to, such as peanuts, or after a bee sting if they are allergic to insect stings.

People who know they have life-threatening allergies, or parents of kids who do, routinely carry the auto-injectors for such emergencies. They often buy extra packs of the devices to have on hand at school.

The FDA earlier this month approved the first generic competitor to EpiPen, but it’s not clear when the new device will be available.

Other competitors that are similar but not exactly the same include Adrenaclick and Auvi-Q.