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Are You Highly Allergic? What To Do About EpiPen Shortage?

The FDA has just warned about an EpiPen shortage. What took the agency so long? Read a tale of woe and intrigue about a life-saving drug.

With warm weather, bees, wasps and other stinging creatures are on the move. That means people who are highly allergic to stings need to keep epinephrine available at all times. This injectable medication can be life saving in the event of an anaphylactic (an-uh-fil-lac-tic) reaction. People with the mysterious alpha gal allergy may also need epinephrine. Read about this dangerous tick-related condition here. Will an EpiPen shortage put people’s lives at risk?

Epinephrine Is an Essential Medicine:

When we think of absolutely critical medications, epinephrine (adrenaline) is very high on the list. It is one of the essential drugs that we would take with us to a desert island:

Epinephrine is a hormone that is made in our bodies by the adrenal glands. It has been dubbed the fight or flight compound. That’s because adrenaline is secreted into the bloodstream at the first sign of danger. It was first marketed in 1900 (Drug News & Perspectives, Oct. 2001).

Epinephrine has been used to reverse anaphylactic shock triggered by a severe allergic reaction. People who are sensitive to foods (like nuts, shellfish, eggs, meat, etc.) or insect stings need immediate emergency treatment if they are exposed to an allergic trigger. Epinephrine also opens constricted airways. That’s why we are so concerned about an EpiPen shortage.

Reversing Anaphylactic Shock:

EpiPen is one of the best known delivery mechanisms for epinephrine. In the old days epinephrine was available in small glass vials. A health professional needed to break open the vial, suck up the epinephrine with a syringe and administer the correct dose as an injection.

But people experiencing a severe allergic reaction only have minutes before the body goes into shock. Symptoms of anaphylaxis may include:

  • A feeling of warmth and/or impending doom
  • Red blotches, rash or hives on the skin
  • Difficulty swallowing or breathing; wheezing
  • Sneezing; runny nose
  • Swelling of the tongue; difficulty speaking
  • Nausea, vomiting or diarrhea; stomach pain
  • Rapid pulse; low blood pressure
  • Dizziness, confusion, fainting or loss of consciousness
  • Coma, cardiac arrest

Health professionals and the FDA realized that while emergency treatment is essential for anyone experiencing a severe allergic reaction, it can take too long to get someone to an emergency department. People could die on the way to the hospital. It became imperative to make epinephrine available to highly allergic individuals and their families.

EpiPen History:

The FDA approved EpiPen in 1987. It was the first autoinjector that made it relatively easy for an individual or a family member to get epinephrine into the body without having to use a syringe. EpiPen took over the marketplace and dominated sales for years.

You may remember the controversy a few years back about the high price of the product. Congressional investigators grilled the CEO of Mylan because the price of EpiPen had gone from $103.50 in 2009 to $608.61 in 2016.

Why Is There an EpiPen Shortage in 2018?

The FDA is reporting that EpiPens are now in short supply. It took the agency long enough. The maker, Mylan, has revealed manufacturing delays following problems at a plant near Saint Louis. This critical medicine is also in short supply in the UK and Canada.

We have always been annoyed by the terms drug companies and the FDA come up with to deal with drug shortages. The official notification from Mylan in this case is no exception. The company reports “intermittent supply constraints.” That is no comfort to a family trying to get a prescription filled at its local pharmacy.

A Tale of Woe and Intrigue:

Issues with EpiPen started showing up this fall. Mylan actually gets its EpiPens from a subsidiary of the giant pharmaceutical company Pfizer. That company, Meridian Medical Technologies, has a plant in Brentwood, Missouri. On September 5, 2017 the FDA issued a warning letter to Meridian. The company was cited:

“Among other things, you manufacture two epinephrine auto-injectors at your facility, EpiPen and EpiPen Jr., (collectively, EpiPen products). These products are intended to deliver a lifesaving drug (epinephrine) during emergency treatment of serious allergic reactions, including anaphylaxis. If your auto-injectors do not operate as expected and deliver the intended amount of epinephrine drug when deployed in emergencies, patients can die or suffer serious illness. You failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness. You also failed to expand the scope of your investigations into these serious and life-threatening failures or take appropriate corrective actions, until FDA’s inspection.”

Should you wish to read more, here is a link to the FDA’s warning letter.

According to Bloomberg News, the company:

“…was warned by the U.S. Food and Drug Administration for failing to investigate hundreds of complaints about defective EpiPens, including cases where patients were hurt or died due to faulty injectors.”

What To Do About the EpiPen Shortage:

To be effective, the EpiPen must be stored properly. Do not keep it in a glove compartment or trunk of a car where the heat can take a toll. People with life-threatening allergies to bees, wasps, yellow jackets or anything else should check their EpiPen to make sure it has not expired.

If it needs to be replaced and the pharmacy is out of stock, ask about an alternative, such as Auvi-Q. Another option, Adrenaclick, may also be in short supply.

Be sure to get clear instructions on how to use Auvi-Q from a trained health professional. Auto-injectors differ. You do not want to start reading instructions in an emergency.

People’s Pharmacy Perspective:

We are dismayed that:

  1. The FDA has only now warned about an EpiPen shortage. Families should have been warned months ago that there might be a problem developing.
  2. There aren’t more epinephrine autoinjectors on the market. There are a number of different products available in Europe. Americans deserve a range of epinephrine options at an affordable price.
  3. Drug shortages are widespread in the USA. The FDA seems powerless to do anything about it. Epinephrine is an absolutely essential medicine. It should never be in short supply!

Share your own allergy story in the comment section below Have you ever experienced an anaphylactic reaction? What was it like? Do you use EpiPen or some other epinephrine injector? Are you concerned about an EpiPen shortage?

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.”.
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