Another option for life-threatening allergic reactions

Susan Farrell, MD

Contributing Editor

For some people, many foods, medicines, and bee stings mean life-threatening allergic reactions that require immediate treatment with injectable epinephrine. For many people, January means the start of a new drug deductible to be met. In June 2017 the FDA approved a new form of emergency epinephrine called Symjepi, which may be good news for people who must be prepared in the event of a life-threatening allergic reaction.

The seriousness of a severe allergic reaction

Severe allergic reactions affect anywhere from 5% to 70% of persons, depending on age and prior exposure. Anaphylactic or “type 1” (immediate hypersensitivity) reactions are the most severe forms of allergic reaction to a substance: insect venom, foods, or some drugs. People who have had prior exposure to an allergic substance are “sensitized” and when they are re-exposed, can have a reaction within seconds to minutes. Anaphylactic reactions are caused by the release of histamine and other chemicals throughout the body, resulting in leaky blood vessels that contribute to swelling of tissues in the mouth and airway and very low blood pressure. These symptoms can lead to difficulty swallowing and speaking, wheezing and severe shortness of breath, and death.

Treating severe allergic reactions

The treatment for severe allergic reactions is the administration of epinephrine (adrenaline) at the first sign of symptoms. Epinephrine is one of the chemicals in the body that raises blood pressure and heart rate. Epinephrine can be administered through an IV in the hospital, but since the 1980s, epinephrine has been available as a pre-filled syringe that can be obtained with a prescription and immediately injected into the thigh muscle when severe allergic symptoms are recognized.

The prevalence of severe allergies has been increasing since 2000. Anaphylaxis to some external chemical or allergen occurs in 2% of the population, and it is estimated that approximately 500 people die from anaphylactic reactions per year in the US. Because of this, more and more people need to have epinephrine available wherever they are (home, school, when traveling). So it is no surprise that the manufacture and marketing of pre-filled epinephrine syringes has been big news in the last two years.

Keeping epinephrine at the ready

Spring-loaded autoinjectors that contain epinephrine have been manufactured by several companies since 1987. In the last 30 years, changes in pharmaceutical companies and patent transfers resulted in a near-monopoly in the production of pre-filled epinephrine products. From 2009 to 2016, one company with a 90% market share dramatically increased the consumer cost for epinephrine injectors, resulting in an investigation and eventual settlement with the US Department of Justice.

Although not a spring-loaded autoinjector, Symjepi consists of two single-dose, pre-filled syringes of epinephrine, for the emergency treatment of anaphylactic and severe allergic reactions in adults. Each pre-filled syringe contains 0.3 mg epinephrine, the recommended initial dose for emergency treatment of anaphylaxis.

At an anticipated lower cost and small size, Symjepi could be an attractive addition to this slice of the pharmaceutical world. In November 2017, the company also submitted a second new drug application to the FDA for a junior version (0.15 mg dose for children between 33 and 65 pounds).

Given the growing prevalence of life-threatening allergies, a new, lower-cost alternative should place the availability of this potentially life-saving drug within greater reach.

Comments:

  1. Anonymous

    Geuss what I live in Georiga and am allergic to trees. I am also a boy scout and love being active and camping in the forest.

  2. Martine

    Since it raises blood pressure quickly, is this dangerous for someone who controls her blood pressure only with her strict DASH diet?

  3. Patricia Champion

    Have recently had episode of significant throat swelling (oropharnynx ) without rash , lips , tongue etc , at 3 am . Was given dexamethasone IV in ER which reduced swelling over some hours . Doctor there considered it viral ( no abnormal bloods ) Blood pressure raised . GP visit the following week said it had to be a severe allergic reaction , not viral and that I needed epi pen etc . Confused , concerned , and no idea what caused it . It was approx 10 hours after any food … Any thoughts would be so welcome , Could highly scented lilies cause such a severe reaction ?
    Patricia , New Zealand

    • Lynette

      You can have a delayed allergic reaction up to a week per my allergist. Most ER docs don’t know this. I also had swelling due to a virus(cold) that I had within 4 weeks of the swelling in my face and throat. I’ve had to use the epi-pen for allergic reactions and I was grateful for it. Very easy to use and worked immediately. I carry one everywhere I go.

  4. Beebs

    Which mechanism of the anaphylaxis does epinephrine alleviates? Heart rate, blood pressure, and ???? Does it help stop swelling of the airways? How?

  5. Anthony Beets

    Susan – Thanks for this article. Could you possibly follow up with Symjepi’s owner, Adamis Pharmaceuticals, to find out why it is taking so long to get Symjepi to market? Thanks

  6. Stan

    I wish they would get this product on the market! Besides the high price, autoinjectors have had two huge recalls in the past couple years. Imagine needing the shot and finding the device malfunctions when you try to use it. Symjepi has fewer moving parts to malfunction and will likely become the standard protection against anaphylactic reactions. Do you have any idea when it will be available?