FDA Extends EpiPen Expiration Dates Amid Shortages

After a summer of EpiPen shortages across much of the United States, the FDA and Pfizer have extended the shelf life of certain injectors up to four months past their expiration dates.

More than 400 people have reported “difficulties filling or refilling [epinephrine] prescriptions at their local pharmacies” since the beginning of May, according to Food Allergy Research & Education. A number of factors have curtailed EpiPen distribution including manufacturing and regional supply issues. Stunted supply occurs at an inopportune time as parents stock up on EpiPens for the new school year.

The FDA has labeled this supply holdup a “spot shortage,” meaning the shortage is temporary, local, and caused by distribution issues. When pharmacies can once again order drugs from their distributors, the shortage will be resolved. Although the FDA denies that the issue is a national shortage, a survey released by Food Allergy Research & Education suggests consumers in 45 states have been affected.

Since their introduction to the market in 1987, the highly-demanded EpiPen has been periodically hard to come by, most notably in 2016 due to price surges. Anticipating the arrival of the first significant competitor in the pharmaceutical market, Mylan raised the price of EpiPens over 400 percent between 2014 and 2016. EpiPens now cost over $600 for two devices.

Last month, the FDA approved the first generic EpiPen competitor distributed by Teva Pharmaceutical Industries, providing consumers with a much more affordable option. Manufacturing and distribution hiccups have caused even generic epinephrine injectors to be unavailable. Although most epinephrine injector brands are reporting shortages, one injector called Auvi-Q produced by a company known as Kaleo remains readily available.

“Based on the information provided by the manufacturer, the FDA anticipates the EpiPen shortage to be short-term,” an FDA spokesperson told NBC news.

In the meantime, if your EpiPen has expired, compare the device with the batch numbers distributed by the FDA to learn whether or not the injector can be used beyond its shelf life. According to Dr. James Baker, CEO of Food Allergy Research & Education, patients can use an expired EpiPen in an emergency but should call 911 to receive medical aid.

The American Academy of Allergy, Asthma, and Immunology reminds consumers that various brands of injectors are activated differently and cautions them to ensure they understand how to administer an unfamiliar brand before they face an emergency situation. Ask your provider for a demonstration of your specific device.

The FDA directs patients experiencing difficulty obtaining EpiPens to call Mylan’s Customer Relations team at 800-796-9526.

Image from Pexels.com

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