The FDA has reported 228 complaints and 7 deaths this year for possible Epipen failure. The FDA received 4 complaints in 2012 for Epipen failure. They also reported 35 cases of hospitalizations. The FDA warned: “There is no certainty that the reported event … was due to the product.”
Food related anaphylaxis is increasing, particularly in young children. The prevalence of food allergy in 2010 was as high as 8% in children younger than 18 years. A most recent study of children 6 months to 18 years of age suggests that emergency room visits for food related anaphylaxis continues to increase.
Intramuscular epinephrine is recommended as the therapy of choice for anaphylaxis. In the event of an allergic emergency, treatment in the thigh with injectable epinephrine is recommended.
Despite the knowledge that epinephrine can save lives, it may be underused by physicians, health care professionals, emergency medical services and patients.
Common features of fatal food anaphylaxis are reactions to peanuts or tree nuts, history of food allergy or asthma, and failure to administer epinephrine promptly. A mild previous reactions does not always guarantee that future reactions will also be mild.
Two doses of epinephrine may be required in approximately 20-36% of cases of anaphylaxis. When one dose is not effective, a patient carrying 2 injectors can administer a second dose while waiting for emergency medical services.
There are multiple epinephrine autoinjectors on the market now. All of them are not the same and have different attributes. Current ones on the market are Epipen, Auvi-Q, Adrenaclick and Symjepi.
Injuries have occurred in children using Epipen, primarily toddlers. Lacerations to the leg, embedded needles have been reported. Data suggests that a new device, one with a shorter needle length, may be necessary to ensure safe injections in children weighing less than 15 kg. A device with shorter, autoretractable needles may prevent unintended injuries in younger patients.
The following is a list of a few products on the horizon in the US and features that will help improve epinephrine autoinjectors.
- Smaller devices and more portable (Adrenacard, Abiliject, Epi-Bracelet)
- Needless injections, sublingual
- Needle lengths appropriate for individual patient needs
- 2 injections within 1 device
- 0.1 mg dose for infants
- 0.5 or 0.75 mg dose for larger adults
- Better temperature stability and longer shelf life
- Impact and weather-resistant casing
- More intuitive and easier to use
- Less expensive
Speak to your allergy doctor to see which epinephrine autoinjector is best for you. All patients should have 2 of them and get regular device training. Increased vigilance for anaphylaxis in younger age groups and public education by allergy doctors is necessary to combat this increasing health care issue.