Photo: An EpiPen, used to treat anaphylactic shock. (Anda Chu/Bay Area News Group/TNS via Getty Images)
Amid a major shortage, the Food and Drug Administration said Tuesday that people can keep certain EpiPens past their expiration dates as parents scramble to find the auto-injectors before school starts.
Depending on the batch and amount of medicine in the EpiPen, some of the auto-injectors can now be used up to four months longer than their printed expiration dates in the case of a severe allergic reaction.The FDA shared the listof these newly approved devices.
The FDA came to this decision afterMylan, the distributers of the EpiPen, requested the extension and provided data to show that it would be safe to use them past the listed, 20-month-long shelf life.
There is currently a shortage of EpiPens due to supply disruptions and manufacturing issues. The FDA announced the shortage in May, and said that based on information from Mylan, they believed the shortage “to be short-term.” But Mylan confirmed on Aug. 8 that it was still ongoing.
“We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season,” Woodcock said Tuesday. “The FDA remains committed to using all of the tools available to help prevent and mitigate drug shortages of medically necessary products used to prevent or treat a serious or life-threatening disease or medical condition.”
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Mylan also had to recall tens of thousands of EpiPens in March 2017 after two separate families reported thattheirs failed to work in an emergency. And in Sept., the FDA sent a warning notice to Pfizer, the manufacturers of the EpiPen, because they did not properly investigate issues at a Missouri plant or resolve complaints about failed EpiPens.
The FDA said that they’re hoping to approve more generic autoinjectors to “remove barriers to generic development and market entry of critically important medicines.”
source: people.com
