|
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.
[to top of second column] |
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.
[© 2017 Thomson Reuters. All rights
reserved.] Copyright 2017 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed. |
