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 These autoinjectors contain a pre-set dose of epinephrine, a
life-saving drug used by people at risk of experiencing anaphylaxis,
a severe allergy attack. Untreated, anaphylactic shock can be fatal
because blood pressure can drop suddenly and airways can narrow,
making it difficult to breathe.
Patients who need these life-saving devices must carry at least one
with them at all times and have access to one everywhere they go.
Soaring prices and out-of-pocket costs for the autoinjectors have
made it increasingly difficult for many patients to keep throwing
out and replacing unused devices when they expire, researchers note
in the Journal of Allergy and Clinical Immunology: In Practice.
The U.S. Food and Drug Administration (FDA) requires autoinjector
expiration dates to ensure that the devices never contain less than
90% of the original dose of epinephrine, the study team notes.
For the study, researchers tested the contents of 46 different
autoinjectors to see how much epinephrine remained after the
expiration dates on the labels. Half of the devices were tested at
least two years after their labeled expiration date. At this point,
80% of the devices still retained 90% or more epinephrine,
indicating they were still effective under the FDA rules.
"If the expiration dating on these devices was changed, this means
that patients would not need to replace their auto-injectors as
frequently, limiting cost to them, their insurance, and the
healthcare system, while still feeling secure that they have access
to adequate treatment for anaphylactic reactions," said lead study
author Lynn Kassel of Drake University College of Pharmacy & Health
Sciences in Des Moines, Iowa.
Devices six months past their labeled expiration date in the study
still had 100% of the original epinephrine dose. One year after the
labeled expiration date, devices still had 95% of the original
epinephrine dose.
And all of the autoinjectors tested that were up to 30 months beyond
their labeled expiration date still had 90% of the dose remaining.
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The study tested far too few devices to help determine with
certainty whether all epinephrine autoinjectors in the U.S. might be
safely used past their expiration dates, Kassel said by email.
The authors also note that they did not test the expired injectors'
effectiveness in stopping an anaphylaxis episode.
"Until the FDA changes the expiration dating guidance for these
devices, patients with anaphylactic allergies should carry
auto-injectors that have not yet expired," Kassel advised.
"The greatest risk of using an expired auto-injector is that the
epinephrine is no longer potent enough to combat the anaphylactic
reaction, and this could result in death or critical illness."
Right now, the expiration date is 18 months from the time the
product is manufactured, a duration that is shorter than the
expiration date for most other medications, said Dr. Kao-Ping Chua
of the C.S. Mott Children's Hospital and the University of Michigan
Medical School in Ann Arbor.
While the study results build on a growing body of evidence
suggesting that expiration dates for epinephrine autoinjectors could
be extended, in the meantime, patients should use the devices as
labeled, Chua, who wasn't involved in the study, said by email.
"I don't think anyone should postpone refilling an epinephrine
auto-injector if they can afford it," Chua said. "In a life-or-death
situation, you want to have as much certainty as possible that the
rescue medication is going to work."
SOURCE: https://bit.ly/2F7WrTT Journal of Allergy and Clinical
Immunology: In Practice, online May 28, 2019.
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