Does Your Baloney or Milk Know When it’s Supposed to “go bad”?

Many people have serious allergies to relatively common substances – peanuts, tree nuts, gluten, and insect stings are among the most common. In just a few minutes a victim will experience a severe, potentially life-threatening allergic reaction, which can escalate quickly. This is anaphylaxis. Symptoms include skin hives, itching, flushed or pale skin, low blood pressure (hypotension), constriction of airways, swollen tongue, wheezing, trouble breathing, a weak and rapid pulse, nausea, vomiting or diarrhea, dizziness or fainting.

The emergency treatment is an immediate injection of epinephrine with a follow-up trip to an emergency room.

The drug itself is inexpensive and has a fairly long shelf life when it’s stored properly in its original vial or ampule. While it takes some dexterity to open the vial, draw up the dose, and make the injection, most people can master the steps.

To simplify and speed treating the emergency, manufacturers offer the epinephrine in a prefilled syringe (EpiPen) that can be quickly jabbed into the victim’s muscle – right through clothing (the time to worry about possible infections is after the emergency has been met and the victim has been transported to the emergency room.)

The devices are costly – several hundred dollars for one treatment – which is reasonable when it saves a life. They bear short Beyond Use Dates (BUDs) – 18 months from the time the product is manufactured – which suggests it ought to be replaced approximately every year. One brand of emergency epinephrine sells for over $500.00 and there is another version that’s slightly less. Anaphylactic reactions are rare because victims know to avoid the substances that trigger attacks. Discarding the out-of-date treatments can often be a significant financial drain. But how likely are the epinephrine syringes to be sub-potent?

Studies performed by Lynn Kassel of Drake University College of Pharmacy & Health Sciences in Des Moines, Iowa have demonstrated that “Devices six months past their labeled expiration date …still had 100% of the original epinephrine dose. One year after, devices still had 95% [potency]. And all of the autoinjectors tested that were up to 30 months beyond their labeled expiration date still had 90% of the dose remaining.” Potencies of 90% are acceptable by the FDA.

People who might need an emergency injection of epinephrine will want assurance that their syringe/device will do the job. We’ve tested several Epi-Pens ourselves and our results match the results of the Drake study above – even at three years past the BUD.

Expiration dates are a fascinating topic and not often grounded in the best science. For epinephrine, scientific testing demonstrates a BUD of up to four years, but the manufacturer uses 18 months. While there’s no recommendation that rescue syringe users ignore the printed BUD, it is suggested that given a choice between not using one past the BUD or using despite the BUD, the wise decision is to use it and still make haste to the nearest emergency center.

In consideration of the testing that supports longer dates, it would be prudent for our FDA to encourage the makers of the epinephrine devices to improve their packaging and work diligently to offer products that have longer dating. Fewer sales may occur, but the net health benefit to the customer should override the financial benefits of selling replacement syringes that are probably safe and effective in spite of the date stamped on the package.