If certain foods or a bee sting can put you into sudden anaphylactic shock, you probably carry a self-injecting epinephrine device. Most likely that device is an EpiPen. In which case, you really need to read about serious issues with EpiPens that could put your life at risk.

For the 2% of people in the US who have a severe allergic reaction—anaphylaxis—when they are exposed to certain foods or a bee sting or some other allergen, getting epinephrine (adrenaline) immediately is a matter of life and death. Epinephrine is the only drug that can reverse anaphylaxis. Since an anaphylactic reaction can happen too quickly to get to the hospital or even to call 911, people who are known to be at risk for such reactions are advised to carry self-injecting epinephrine devices with them at all times. In the US, an EpiPen is the most common such device. About 3.6 million EpiPens are sold each year, and EpiPen prescriptions have doubled over the past 10 years. For the most part, EpiPens have indeed saved lives. But there also can be serious problems…

MALFUNCTIONS

From 2013 to 2014, reports of EpiPen malfunctions increased 400%. This led to an FDA inspection of the Pfizer-owned facility where EpiPens are made…the discovery of epinephrine leaks in some devices and failure to fire when triggered in others…and ultimately the recall of several batches of EpiPens. More recently, the FDA sent the distributor, Mylan Pharmaceutical, a warning letter because the company had failed to investigate 228 reported malfunctions, including several incidents in which patients died.

As of November 2017, Mylan has stated that it is confident that EpiPens currently being manufactured are safe and effective. It also pointed out that people can die from anaphylaxis even when medication is delivered properly…that any medical device in the hands of a nonmedical person has a high risk of being used improperly…and that some people can have a severe adverse reaction to epinephrine itself.

SHORTAGES

Shortages of epinephrine auto-injectors have been an increasing problem not just in the US but also in Canada, where EpiPens are available at pharmacies without a prescription. (While US citizens can buy EpiPens in Canada and use them in Canada, border customs officials might not allow them to be brought into the US.) In 2018 in the US, it has been so difficult to fill a prescription—both for the adult version of EpiPen and for EpiPen Jr, the pediatric version—that the FDA has extended the usual expiration dates on the devices by a few months. Their reasoning is that a weakened injection of epinephrine is better than none. Nor is EpiPen the only epinephrine device in short supply. Shortages of generic brands marketed by Mylan have been reported, as have shortages of Adrenaclick, an auto-injector made by one of the two EpiPen competitors.

What’s causing the current shortage is not known outside of Pfizer and Mylan. It could be a combination of the recall diminishing the supply and an inability of the manufacturer to keep up with increased demand. Food Allergy Research & Education (FARE), a nonprofit advocacy organization, has called on the FDA to declare a national shortage and to demand action from Mylan to explain and address the shortage.

One epinephrine auto-injector is not in short supply—Auvi-Q. The manufacturer, Kaleo, says that it is making sure that commercially insured patients can receive Auvi-Q with no out-of-pocket cost. Note: Auvi-Q had a voluntary recall in 2015. The new version, which reflects changes made to remedy the problems, is supposed to be reliable. Again, as with EpiPen, there is no way to know for sure.

AFFORDABILITY

When Mylan bought distribution rights to EpiPen in 2007, it raised the price of a two-pack of injectors from $100 to more than $600, making EpiPens too expensive for many people with poor or no insurance. (Note: Current recommendations are to carry two injectors at all times. If you are not able to get to emergency medical care within 15 minutes, it is recommended to inject a second dose of epinephrine.)

Mylan’s response to complaints about its pricing was to develop its own generic auto-injectors. But at $300 for a two-pack, they are still not very affordable. Patients who can’t or don’t want to pay the high prices have taken to carrying prefilled syringes of epinephrine…or carrying auto-injectors that have expired. Prefilled syringes are not a good alternative. They are harder to use—a potentially deadly complication for someone going into anaphylactic shock who is likely to be confused and unable to give himself/herself an intramuscular injection properly.

WHAT YOU CAN DO

To work around the problems of epinephrine auto-injectors’ pricing and availability…

  • Ask your doctor for a prescription that doesn’t specify a particular brand name. That way, your pharmacy can dispense to you whatever type is available. Note that other brands do not function mechanically in the same way as EpiPen. If your pharmacist gives you a different brand than you’re used to, read the directions very carefully ahead of time…so you’ll be able to follow the instructions correctly when you need to use it. Most devices come with a blank “trainer” that can be used for practice. Pharmacists also can show you how to use the device.
  • Plan ahead for refills because it may take several days for your pharmacy to find an auto-injector for you. EpiPen and Auvi-Q have websites where you can find links for help with availability or financial assistance.
  • In some cases, adult patients have been accepting a pediatric epinephrine auto-injector if an adult one is not available. The most effective dose of epinephrine needed for an anaphylactic event has not been scientifically established—current doses are more convention than proven by factual data. It is reasonable to carry a pediatric version if that is all that is available. If the dose isn’t enough, give a second one.
  • Use the auto-injector if you need it! You’d think that this advice is unnecessary, but the biggest problem with all auto-injectors is not failure of the device but failure of people to use the device. For example, a recent study found that in more than 2,000 emergency-room visits for an anaphylactic reaction at 34 US hospitals, only about 20% of the patients took or received epinephrine before coming to the ER.

MORE COST/SUPPLY RELIEF?

Relief for at least short supply may be around the corner. The FDA announced in August its approval of an epinephrine auto-injector made by an Israeli company called Teva. Mylan is suing Teva for patent infringement, but the Teva device is now approved as a generic competitor to EpiPen, although it is not yet available in US pharmacies. However, currently priced at $300, the Teva auto-injector is not the cost-saver that was hoped for.