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 Patients with serious allergies typically carry an emergency
autoinjector - such as the EpiPen made by drugmaker Mylan NV - at
all times. The devices are used to deliver an emergency dose of the
hormone epinephrine to patients who may go into life-threatening
anaphylactic shock.
"We work with hundreds of patients with histories of anaphylaxis,
who carry epinephrine on a daily basis," lead author Piotr Lacwik,
who works at the Medical University of Lodz in Poland, said in an
email. "I noticed that not all of them have their epinephrine on
them at all times and, alarmingly, some leave injectors in the car."
For the study, Lacwik and his team purchased 12 EpiPen Senior
injectors from the same lot to ensure consistency. They distributed
nine EpiPens between the glove compartment, cabin shelf and trunk of
a car parked in a treeless area. The remaining three were stored in
a dark, air-conditioned room at a constant temperature.
After half a day, the researchers retrieved the EpiPens from the car
and cooled them to room temperature before testing their contents.
They found that the concentration of epinephrine in the
autoinjectors was reduced by 3.3 percent in samples placed in the
trunk, 13.3 percent in those placed in the cabin and 14.3 percent in
those left in the glove compartment.
Most guidelines recommend 0.3 mg or 0.5 mg as an initial dose for an
adult. Because the EpiPen Senior has a total dose of 0.3 mg, any
deterioration puts the dose below the recommended threshold, Lacwik
said.
The EpiPens in the glove compartment were noticeably warm to the
touch when retrieved, researchers noted. This was because the
enclosed space likely reduced the dissipation of heat even when
ambient temperatures began to drop, they explain in The Journal of
Allergy and Clinical Immunology: In Practice.
Paradoxically, epinephrine in low concentrations can worsen
anaphylaxis, the authors write, but Lacwik notes the decreases seen
after a single exposure to heat in the study are unlikely to produce
that effect.
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A spokeswoman for Mylan said that while the company was not involved
in the study, "its findings are consistent with the storage
guidelines outlined in the FDA-approved label for EpiPen
Auto-Injector."
"Per the label, EpiPen Auto-Injector is to be stored at 20°C to 25°C
(68°F to 77°F)," she said.
The report notes that although prescribing and patient information
available online includes a warning against glovebox storage of
EpiPens, the leaflet enclosed with the devices did not.
Allergist Dr. Purvi Parikh, spokeswoman for the Allergy and Asthma
Network, pointed out that the study tested only one brand of
autoinjectors, in only one make and model of car. Still, she called
the results "concerning," as many patients keep their autoinjectors
in their cars for convenience.
"Patients likely are not aware of this risk in general and need to
be advised," Parikh, who was not involved in the study, told Reuters
Health.
"With anaphylaxis, timing of epinephrine dosing is crucial in saving
lives and so if the epinephrine is ineffective (it) can be deadly
for patients."
Lacwik too said the results might not translate precisely to other
formulations of epinephrine in other climates or car models. But
"while our study did not check any of those alternatives, we believe
that the general conclusion- a warning against leaving autoinjectors
in the heat - can be applied to all formulations of epinephrine
available on the market," he said.
SOURCE: http://bit.ly/2Pv42hC The Journal of Allergy and Clinical
Immunology: In Practice, online November 28, 2018.
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