By Ronnie Cohen
(Reuters Health) – It’s worth a shot to use an expired EpiPen, if that’s all you have, a new study suggests.
For more than four years past their stamped expiration dates, the handheld injectors retained high-enough concentrations of epinephrine to in all likelihood prevent potentially fatal allergic reactions, the study found.
The manufacturer advises patients to replace the life-saving EpiPen devices annually. Worried that surging EpiPen prices make yearly replacement unaffordable for many families, pharmacist F. Lee Cantrell analyzed 40 expired EpiPens and EpiPen Juniors.
Cantrell, who directs the California Poison Control System in San Diego, found that the auto-injectors did lose potency over time. Even 50 months past expiration, however, the EpiPens retained 84 percent of epinephrine concentrations – enough to prevent anaphylactic shock, he said in a phone interview.
“In every pen we tested there was enough to give what would be considered a therapeutic dose,” said Cantrell, lead author of a letter published Monday in the Annals of Internal Medicine.
“If my kid’s having a life-threatening reaction, and I had no alternative, absolutely I would use it without hesitation,” he said. “I don’t think there’s a physician in the world who would rebut that.”
Dr. Kao-Ping Chua, a pediatrician and professor at the University of Chicago, agreed, though he stressed his belief that it is crucial to replace expired EpiPens with in-date ones.
At the same time, he joined Cantrell in calling on regulators and Mylan, the EpiPen manufacturer, to re-evaluate the product’s life span.
“I think the whole process of expiration dating in the United States needs to be revisited and potentially revised,” Cantrell said. “The results could be enormous cost savings to consumers.”
Mylan has filed an application with the U.S. Food and Drug Administration for a new EpiPen formulation, which would extend the product’s shelf life, Julie Knell, Mylan’s senior director for global product communications, said in an email. She said she could not reveal anything more about the confidential application.
In September, Mylan CEO Heather Bresch told the U.S. House Committee on Oversight and Government Reform that the drug-maker hopes to offer an EpiPen with a 24-month shelf life within a year.
Mylan came under fire beginning last year for raising the price of a pair of EpiPens to more than $600 from $100 in 2008.
EpiPens currently expire 18 months after the date of manufacture. But a number of pharmacists have told Cantrell that they do not receive the devices until six months after they were manufactured, putting the injectors into patients’ hands with less than one year left until they need to be replaced.
In September, Mylan announced it had agreed to a $465 million settlement with the U.S. Justice Department over how the drug was classified for government buyers.
Patients’ out-of-pocket spending for EpiPens climbed 535 percent from 2007 to 2014, another recent study found. The number of annual EpiPen prescriptions nearly tripled during the same period.
The expiration dates stamped on EpiPens reflect “the final day, based on quality control tests, that a product has been determined to be safe and effective when stored under the conditions stated in the package insert,” Knell said. “Given the life-threatening nature of anaphylaxis, patients are encouraged to refill their EpiPen Auto-Injector upon expiration, approximately every 12 to 18 months.”
People with severe allergies to things like peanuts, shellfish, bees or penicillin might be prescribed EpiPens to keep on hand for emergencies. Untreated anaphylactic shock can be fatal because blood pressure can drop suddenly and airways can narrow, making breathing difficult.
For parents with high-deductible insurance or high copayments, the choice of whether to buy a $600 pack of EpiPens for an allergic child or food can be challenging and distressing, said Cantrell and Chua, who was not involved in the new study.
“All of this comes back to the price,” Chua said in a phone interview. “Why is Mylan putting us as patients into a position where we have to decide between doing the best thing for our children versus paying $600, which is money that can’t go towards rent?”
“I don’t think anyone should be relying on an expired EpiPen if they have a choice,” he said. But, he added: “If all you have is an expired EpiPen, and you need it, then use it. It’s better than nothing.”
SOURCE: http://bit.ly/1i46lF7 Annals of Internal Medicine, online May 8, 2017.