FDA extends EpiPen expiration dates amid nationwide shortage

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Wednesday, August 22, 2018
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Kristin Thorne has more on the extension of EpiPen expiration dates.

WASHINGTON (WABC) -- The Food and Drug Administration is extending the dates of some EpiPens by four months in an effort to help combat shortages of the life-saving drug as children head back to school.

Michelle Cruz, of East Meadow, has an 11-year-old son who is deathly allergic to peanuts. She has a few EpiPens that expire in January 2019, but her son's school requires three that can last the entire school year.

"It's a fear that I have, that we're going to have this expired EpiPen that in all emergencies, obviously, I'm going to use it, because something is better than nothing," she said. "But is it going to work? How well will it work? And Is it going to potentially save his life at that point?"

The extension only applies to specific lots of 0.3 milligram products from Mylan. Normally, EpiPens are approved for a 20-month shelf life.

"Normally I would not advocate using something past the expiration," said Howard Jacobson, with the Long Island Pharmacists Society. "But as long as the FDA says that the company can publicize that it is good past the expiration, then I would say, look, God willing, you don't have to use it."

The drugs have an expiration date between April and December 2018. It does not apply to EpiPen Jr., which is used for kids weighing between 33 and 66 pounds and provides half the dose of epinephrine.

"We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season," Dr. Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research said in a written 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. 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."

Last week, the FDA approved the first generic versions of EpiPen.

EpiPens are auto-injectors that deliver epinephrine to help treat life-threatening allergic reactions.

About 1 in every 50 Americans can suffer life-threatening allergic reactions to food items, insect bites or stings, and latex.

You can see the full list of impacted EpiPens here. If you are experiencing difficulty filling an EpiPen prescription, contact Mylan Customer Relations at 1-800-796-9526.


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