Epinephrine is the only medication and first-line treatment for anaphylaxis, a severe and potentially life-threatening allergic reaction to food, insect stings or bites, drugs or other allergens. A synthetic form of the hormone adrenaline, it comes as a pre-filled automatic injection device. Four FDA-approved epinephrine auto-injectors currently are on the market. However, since the FDA declared a national shortage of certain products in May (and issued another statement on June 19), Northeast Ohio and other parts of the country are experiencing intermittent supply issues.

Dr. Abigail Glick is director of the Northeast Ohio Food Allergy Network (NEOFAN), a regional support and advocacy group for families with food allergies. Glick, who also is a “food allergy mom,” says, “NEOFAN families have been impacted by the shortage of devices, including EpiPen and the authorized generic of Adrenaclick. This causes significant anxiety and also poses a health risk. However, alternate epinephrine auto-injectors can be more easily obtained, including AUVI-Q.”

According to the FDA and manufacturers, these products are impacted by the shortage as of July 25:

• Mylan EpiPen 0.3 mg and EpiPen Jr. 0.15 mg epinephrine auto-injectors and the authorized generic versions of these strengths — FDA reports products are available with intermittent supply constraints due to manufacturing delays. For assistance in locating a pharmacy with EpiPen in stock, contact Mylan Customer Relations at 800-796-9526.
• Impax Laboratories (Amneal Pharmaceuticals) authorized generic of Adrenaclick 0.3 mg/0.3mL and 0.15 mg/0.15 mL epinephrine auto-injectors — FDA reports manufacturing delays; company indicates backorder. To contact Impax Customer Service, call 877-994-6729, option 3. (Note: Adrenaclick is not currently offered under the brand name label.)
• Kaléo AUVI-Q (0.3 mg, 0.15 mg and 0.1 mg epinephrine auto-injectors) is currently the only product readily available and not currently in shortage.

Epinephrine product issues like this are not new.

Cleveland Clinic Allergist Dr. Sandra Hong described how, during her 15 years in practice, auto-injectors have experienced shortages, been pulled from the market or recalled for periods of time for various reasons.

“Had this happened 3 to 5 years ago, everyone would be out of the devices, but the place where we are at is wonderful with options,” Hong says. While she hasn’t seen much backlash from the shortage at her Strongsville practice, Hong notes more widespread knowledge of the availability of these options is needed.

Food Allergy Research & Education reminds patients that all the devices contain epinephrine, but the delivery device — and instructions for using it in an emergency — are different for each product, particularly AUVI-Q.

Back-to-School Tips

Always avoid allergens, understand the symptoms of anaphylaxis, have an emergency care plan in place and carry epinephrine with you at all times. Hong offers this advice:

• Check expiration dates. Before accepting the medication from your pharmacy, make sure it’s good for a full year, as it could have been sitting on the shelf a while.
• Retrain school nurses, teachers and other staff. While the medication is the same, the applicator mechanisms vary. Each set comes with a trainer device without medication.
• Reference company websites for instructional videos and practice.
• Don’t wait until the last minute to fill prescriptions. In case supplies don’t meet seasonal demands, fill prescriptions promptly to avoid interruptions in medication.
• When in doubt, give epinephrine. Hesitation is normal, but Hong recommends if the patient in need is an otherwise healthy individual, do not hesitate. The sooner it is administered the better — and call 911 immediately.
  
• Don’t confuse epinephrine with antihistamines. FARE reminds patients that antihistamines do not treat anaphylaxis and have no life-saving capacity. Medications like diphenhydramine (Benadryl) and cetirizine (Zyrtec) are used to relieve mild allergy symptoms (e.g., itching, sneezing, hives and rashes) and cannot stop a severe reaction.