EpiPen injector, EpiPen maker

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:

What Are the Best Drugs for a Desert Island Adventure?

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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  1. James
    Redlands, CA
    Reply

    Taking 2 pills of an over-the-counter homeopathic remedy called Arsenicum Album 30 C every 1 hour (for not more than 8 hours) would help with decreasing the intensity of an acute allergic reaction before going to ER.

  2. Judith
    Grand Rapids MI
    Reply

    I have had severe anaphylactic reactions to wasp stings and have been advised to carry 2 Epipens with me at all times. Imagine my surprise when told by my Pharmacist this week that they only had one brand name Epipen in stock, and generic brands are only covered by my insurance so it would cost $375 with the pharmacy card “discount.” They had no idea when more would be in stock. It is a disgrace that the FDA cannot regulate these drug companies to the extent that they can keep a life-saving drug in stock.

  3. Diane in Western New York
    Western New York
    Reply

    I experienced two serious allergic reactions before there was such a thing as an epipen. In one case I had benadryl pills with me. I chewed a tablet. In another instant I had my steroid nose spray with me and I directed it down my throat which was starting to close with swelling. I now carry an EpiPen. My allergist said it is OK beyond the printed expiration date as long as the liquid color is clear. There is a rectangular window on the pen that lets you see the color of the liquid. The allergist said the color of the liquid is more important than the stamped expiration date.

  4. Mark C
    GA
    Reply

    I have required an epinephrine for fire ants and later yellow jackets since the 80’s. I can remember buying them for less than $40. Way back there was a competitor. It was a glorified syringe filled with epinephrine. My last purchase of an epipen was at a Walmart in Saulte Saint Marie, CA in Oct 2016. I walked in and paid $104 C (less than $80 US). No prescription was required. A doctor who appears on Reluctant Preppers was relating how he just gave away ampules of epinephrine with syringes to his clients.

    An online Canadian Pharmacy has available another brand of Epipen for $79 under the brand name Emerade. This appears to be part of Bausch and Lomb. Of course, this brand is not sold in the US. The epipen is a very low tech product. The active ingredient is cheap.

    The fact that we have extortionate pricing and product unavailability is a team effort between monopoly pharma and the crooked FDA. You could also ask Joe Manchin. His daughter is the CEO of Mylan Labs. She makes a little less than $13mil/ yr (per Wikipedia)

  5. Larry M
    Raleigh, NC
    Reply

    Joe wrote “People with life-threatening allergies to bees, wasps, yellow jackets or anything else should check their EpiPen to make sure it has not expired.”

    This statement ignores the testing performed by NIH in 2000 (!) which showed that after five years the EpiPen potency only drops by 25%.(Citations posted by me to a previous PP article.) Observe that the adult dose is considered adequate for anyone from 80 lbs to 500 (or more) lbs. The 120-lb woman or 200-lb man will be dosed quite adequately by a pen degraded to 75% of original potency.

    Causing anxiety and panic over the temporary shortage isn’t responsible. Your readers would be better-served by your initiating a movement with the FDA to change the expiration period to a more reasonable figure.

    • Joe Graedon
      Reply

      Larry, would you want to take the gamble if your child was severely allergic to peanuts or wasps? You may be right that epinephrine could still be active long after the expiration date, but what if your advice led to someone’s death. Are you willing to accept liability? Here is what Consumer Reports states about this:

      “It’s important to replace your epinephrine injector before the expiration date stamped on the pen. That’s because epinephrine deteriorates over time and relying on an outdated one (past the standard 12- to 18-month expiration date) can leave you with an auto-injector that’s less effective, or not effective at all, when you most need it.”

      How epinephrine is stored can have a profound impact on shelf life. If a parent carries the EpiPen around in a pocket book or leaves it in a glove compartment it is likely to deteriorate faster. This is not a drug like Valium or Prilosec. If epinephrine fails to work as needed it can be game over.

  6. Grace
    Reply

    This is a historical note on injectable epinephrine:
    In the late 70s, a family member finally identified the allergen causing frequent and worsening reactions. Sulfite, a widely used food anti-oxidant which was “Generally Regarded As Safe” at that time .

    His doctor advised having that drug available just in case. As the pharmacist and doctor and wife looked at his options, what did they discover? All but one injectable epinephrine was “stabilized” with … wait for it … sulfite. The only one available without sulfite was stablized with … latex. Needless to say he focused on avoidance. This was a decade before any labeling for sulfite was required on foods. Good thing his wife was a clinical chemist and had the ability to purchase sulfite-specific chemical test strips which detected low levels he reacted to.

    Just another complexity in the drug world.

  7. David
    Texas
    Reply

    This drug, epinephrine, is dirt cheap, and the ripoff from certain companies should be criminal. Taking advantage of situations is the way in America and the world today, but with a life-threatening drug situation like this it should really demand criminal prosecution. This is as bad as someone holding you hostage with a gun to your head demanding money. I say this as a pharmacist.

  8. Gerry
    Fla
    Reply

    I was diagnosed with angioedema in year 2000. I suffered swelling of tongue and throat almost to the point of death after drinking a small amount of Coke. Subsequently learned I am allergic to all salicylate. Any “fizzy” drink triggered it at that time. After being successfully treated for this major event, my doctor prescribed nightly dose of benadryl, zyrtec and zantac. I have taken these faithfully since and now can eat small amounts of certain things like tomatoes, strawberries, and other high-salicylate foods without a reaction. I also react in a huge way to any insect bites or stings. My doc said to pop benadryl between teeth, and let powder spread below and above tongue for immediate treatment. My epipens are out of date.

    Prior to being dxd any insect sting would render me totally helpless within a very few minutes, arm swelled to double in size after hornet sting on finger. I am allergic to many things such as novocain, etc. for dental work; I always carry benadryl in my purse and take one capsule before dental work. Small flies (green head flies) or mosquitoes affect me strongly, and I have to scrub the site with yellow soap and treat with betadine solution as soon as possible to avoid 3 days of itching and swelling on leg or arm. So with the ingestion of banedryl, zantac and zyrtec every night I am surviving. I am 81.

    • Jenny
      New York, NY
      Reply

      I had an extreme reaction to a yellow jacket sting (after a somewhat lesser one, years before) and though I took two OTC (over the counter) Benadryls, right away, I ended up in the hospital, swollen up and needing intravenous antihistamine and something else. I then needed to be treated with steroids for weeks afterwards and required several medications for asthma for well over a year.

      I have two Epipens that have expired and haven’t been able to get new ones. In addition, my doctor no longer is here, so until I have a new doctor and can get an appointment, I can’t get a prescription for a new Epipen. Could you tell me what the dosage is on the antihistamines you take? My dipenhydramine (generic of Benadryl) is the usual OTC dosage.

      I am wondering whether it would be safe for me to take the three antihistamines that you take until I can get new Epipens.Though they cost hundreds of dollars, I believe I need to protect myself with Epipens, though perhaps the ones I have still are effective.

      Any suggestions, anyone? Thanks

  9. Christine
    Australia
    Reply

    I have had anaphylactic reactions to to bee stings and wasp stings. The first time I did not have an epi-pen, so while waiting for the ambulance I took homeopathic Apis (which is a remedy for many anaphylactic reactions – especially swelling of the throat, airways etc), and the anaphylactic reaction stopped before the ambulance arrived. So, following this, I have used Apis subsequently very successfully. It is much better than relying on an Epi-pen that isn’t available a lot of the time because it is now a political football over price/profits.

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