FDA Addresses EpiPen Shortage By Extending Expiration Date On Some Injectors
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PHILADELPHIA (CBS) – With nationwide shortages of the potentially life-saving EpiPen, the Food and Drug Administration is taking action to address the problem.
The FDA is extending the expiration dates on some injectors in an attempt to ease shortages of EpiPens that are used to treat allergic reactions to everything from food to pets to insect bites. Those reactions can be deadly if not treated quickly.
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Six-year-old Nathan Schuller-Meyer has a life-threatening food allergy. Like millions of people, he doesn't leave home without his EpiPen, but his mom says finding one this summer hasn't been easy.
"I tried to get our beginning of the school year and was told there was a wait. Our Walgreens told us it might be October before they get any in," said Clarissa Schuller-Meyer, the young boy's mother.
The EpiPen has been on the FDA's drug shortages list since May due to supply disruptions and manufacturing issues.
"It's quite frightening for anybody who can't get ahold of EpiPen, who absolutely needs it," explained Dr. George Martin, chief of allergies and immunology at Lankenau Hospital.
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To help in the short-term, the FDA and the EpiPen manufacturer Pfizer are extending the expiration date of many EpiPen products and their authorized generic versions by four months.
FDA takes additional action to mitigate shortages of EpiPen by extending expiration date for specific lots of medication https://t.co/nFRdDkEkqu
— Media Affairs (@FDAMedia) August 22, 2018
The extension does not apply to the EpiPen Junior. Officials say they've reviewed the data and patients should feel confident using the products as they work to stabilize supply.
"You can take a look at the EpiPen and you can see if the fluid is clear, it's perfectly fine. If it has a yellow or tan tinge to it, it's no good," Dr. Martin demonstrates.
EpiPens should be kept at room temperature to ensure they remain effective and families having trouble finding EpiPens are encouraged to consider alternatives.
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However, the alternative, like Auvi-Q, could be more expensive and not always covered by insurance.
The Auvi-Q is an example of one that is more expensive, but equally effective alternative to the EpiPen.
Pfizer expects the EpiPen to be more readily available between October and December.
A generic version made by TEVA has been cleared and it's expected to be available soon, but no exact date has been confirmed. It is also expected to be less expensive.