December 11, 2018
Originally Published: Managed Healthcare Connect – https://bit.ly/2Gmgscr
By: Tamara Mathias
(Reuters Health) – The epinephrine in emergency allergy shots like the EpiPen can deteriorate when exposed to heat, so they shouldn’t be left in the car on a hot day, researchers warn.
“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% in samples placed in the trunk, 13.3% in those placed in the cabin and 14.3% 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, in a report online November 28.
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.
A spokeswoman for EpiPen manufacturer 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.
Managed Healthcare Connect – https://bit.ly/2Gmgscr | Dec. 11, 2018