FDA Extends Some EpiPen Expiration Dates to Fight Shortages

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In response to worrisome shortages of EpiPens recently announced, the Food and Drug Administration announced that it has taken steps to extend the expiration dates of EpiPens already in circulation.

EpiPens are devices that autoinject dosages of epinephrine, which is used to counter allergic responses to insect stings, or other allergens like peanuts, that can turn into a life-threatening emergency known as anaphylaxis.

The shortage caused worries, as children across the country headed back to school this month. Many parents of children who are at risk for severe allergic reactions like to have multiple EpiPens to keep at home, in the car and at school. Parents sought to renew their children’s EpiPen prescriptions before school started and many were shocked to learn that the important devices were in short supply.

“In my busy pediatric clinic, we’ve noticed there are a number of patients calling in wondering where they can procure their EpiPens, since most pharmacies are having trouble keeping them in stock,” Dr. Stacy Dorris of the department of pediatric allergy and immunology at the Vanderbilt University Medical Center told CNBC recently.

In that report, CNBC said its representatives called two dozen pharmacies located across the country and nearly each one said it had no EpiPens or very few in stock.

The shortage has been caused by manufacturing delays. EpiPens are manufactured by Meridian Medical Technologies, a subsidiary of Pfizer. Just last week, the Inquistr reported that the first generic version of EpiPen had been approved. The generic EpiPen, which is made by Mylan, is also manufactured by Pfizer.

“Mylan and Pfizer take the supply of EpiPen and EpiPen Jr Auto-Injectors very seriously,” said Mylan in a statement. “A few months ago, Mylan informed FDA of intermittent supply constraints due to manufacturing delays from Pfizer. Since this time, Mylan and Pfizer have remained in close contact with FDA to provide regular updates on the inventory status.”

The FDA’s website says that the branded and generic versions of EpiPens may continue to be used beyond the manufacturer’s labeled expiration date. However, in order to be safely used, they should have been stored as labeled and they should continue to be stored as labeled.

Based on the FDA’s data, specific batches listed in a table on its website are suitable for the extended use. The FDA says it may expand the batches that can be safely used as they continue to gather data on the product’s stability.