A new study suggests the notoriously expensive EpiPens may have a longer shelf life than would be expected from the product’s expiration date. Even a couple of years after the pens have supposedly expired, researchers found they still contained a therapeutic amount of the active ingredient, epinephrine. While the researchers are careful not to advocate the replacement of in-date pens with expired ones, they do make the case that, in a pinch, an EpiPen may still be life-saving even if it’s past its expiration date.
Last year, Mylan, maker of the EpiPen, came under heavy public fire for increasing the price of its life-saving device to what some considered insensible levels. The 2-pack cost $100 in 2007; in 2016, the same 2-pack soared to over $600. The price hike even got the attention of Senator Charles Grassley who formally asked Mylan to explain their pricing.
Under scrutiny Mylan tried to offer vouchers for the brand-name devices. When that didn’t go over well either, they developed a cheaper, generic alternative. Critics aren’t shy about pointing out the fishiness of a drug company offering both the brand-name and generic versions of an off-patent drug. But the generics are priced at $300 for a pair of pens, which is less offensive, but still quite pricey to patients and their families. And given that the pens’ printed shelf life is about one year, the cost of annual replacements can add up quickly.
But can the pens be used after their printed expiration dates? Researchers at the University of California, San Diego say the pens may be potent even years after they “expire.” The study focused on the epinephrine concentrations of 40 expired EpiPens and EpiPen Jrs. At 29 months, the pens had at least 90 percent of their epinephrine content. At 50 months, the pens still contained 84 percent of the active ingredient. These levels are well within the therapeutic range, experts say.
"Our paper is not suggesting that people take expired medication," said Lee Cantrell, the lead study author. "We can't make that leap based on our data. But what we can say is that if you have nothing else, and you're having a life-threatening reaction, certainly use the expired epinephrine."
But people shouldn’t rely on dates alone. The color of the liquid is an important telltale sign of whether the product is still good or should be tossed. "There's a little window on each one. If it's discolored, you shouldn't use them, period," warned Cantrell. Safe and potent EpiPen solution are usually clear and colorless; anything other than is an indicator that the product’s gone bad.
The study makes a good case for the longer-than-expected shelf life of EpiPens. But when it comes to important medications like epinephrine, people aren’t so keen to trust an expired pen. For parents of children with life-threatening allergies, even though they may believe the expired pen is still good, they dutifully get replacements every year.
"The reason I buy new ones? I want to be a good mom and follow the recommendations. That, and the schools will not accept them if they are expired," said Meriles Hufnagel, a mother of a child with severe peanut allergies.
Cantrell’s study is not the only one to conclude that EpiPens have a longer shelf life than the printed label. So why doesn’t Mylan extend the expiration date? In a statement, the company said: “An expiration date is the final day, based on performed quality control tests, that a product has been determined to be safe and effective when stored under the conditions stated in the package insert. Given the life-threatening nature of anaphylaxis, patients are encouraged to refill their EpiPen Auto-Injector upon expiration, approximately every 12 to 18 months. Mylan also continues to invest in product improvements, such as a formulation with a longer shelf life."
But given the company’s blatant history of greed, the discrepancy between the printed versus the actual expiration dates is still hotly contended. "Until those labels are changed, patients are in a bad situation, because they're concerned about having a life-threatening event and not having a medicine that's effective," said Thomas Casale, a professor of medicine at the University of Florida who was not involved with the study.
Additional source: CNN