Expired EpiPens may still help save a life: study

May 9, 2017 by Dennis Thompson, Healthday Reporter

(HealthDay)—EpiPens—devices used to rescue people during a severe allergic reaction—can remain effective years after their expiration date, a new study reports.

An evaluation of almost 40 expired, unused EpiPens brought in by patients revealed that all of the devices contained more than 80 percent of their initial dose of epinephrine. This was true even as long as four years past the expiration date on the device, said study lead researcher F. Lee Cantrell, director of the California Poison Control System - San Diego Division.

People unable to replace an old EpiPen due to pharmacy shortages should hold onto it past expiration, because the device could still contain a lifesaving dose, Cantrell concluded.

"There's still a dose that would be therapeutic in there," he said. "If this is all you have, this is better than nothing."

Cantrell still recommends people replace expired EpiPens if fresh ones are available, as a matter of safety.

"If it's me, if I'm highly allergic to a bee sting, I want something that I know is going to save my life," Cantrell said. "At the same time, if an expired EpiPen is all that I have, I would use it."

However, he believes the U.S. Food and Drug Administration and the maker of the EpiPen, Mylan, should reassess the expiration date set for EpiPens to see if it can be extended.

Expiration dates are based on studies conducted during a drug's evaluation process that test its stability in both ideal and poor storage conditions, the FDA said in a statement. After approval, companies are required to continue these studies, and can request an extension of the expiration date if the data supports it.

In a statement, Mylan said its products carry expiration dates that reflect the final day "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," the company's statement reads. "Mylan also continues to invest in product improvements, such as a formulation with a longer shelf life."

Cantrell and his colleagues conducted their study after a steep hike in the price of EpiPens caused a consumer rush at pharmacies.

Mylan obtained the rights to sell the EpiPen in 2007, and has since increased the list price of the auto-injector from $94 to $609, according to news reports. People with extreme allergies keep EpiPens on hand to prevent a potentially fatal allergic reaction.

In response to patient outcries over the price increase, Mylan released a $300 generic version of the EpiPen.

Pharmacists reported to Cantrell that people started buying out all their EpiPen supplies as prices continued to rise.

"People got really scared their insurance carriers were no longer going to pay for the drug because it was so expensive, so everyone went to pharmacies and cleaned them out," Cantrell said. "They wanted to stockpile and get them while it was still covered."

Patients began calling centers to see if an EpiPen would still be good for use past expiration, prompting Cantrell and his colleagues to seek an answer.

During two weeks, patients at a community clinic in San Diego were asked to bring in unused, expired EpiPens so they could be examined, the researchers said. The team ended up with 31 EpiPens and 9 EpiPen Jrs.

None of the pens was discolored—a sign that it's gone bad and should not be used, Cantrell said.

Analysis revealed that all of the pens still retained most of their potency. The lowest level of epinephrine, 81 percent, was found in an EpiPen Jr. 30 months past its expiration date.

About 65 percent of the EpiPens and 56 percent of the EpiPen Jrs. contained at least 90 percent of their initial epinephrine dose, the researchers concluded.

Despite these findings, allergist Dr. Andrew Murphy said patients should not hold off replacing their injector to save money.

"The drug is labeled to be good to a certain date," said Murphy, who practices in Downingtown, Pa. "That's what I know as a prescribing physician, that the FDA and the pharmaceutical company have guaranteed that.

"Having said that, if someone is at home and they're having a reaction and the only thing they have available is an expired epinephrine injector, as long as it's not yellow or cloudy or has something floating in there, go ahead and use it," Murphy continued.

A larger study is needed to confirm what this new paper reports, Murphy said, but the findings do indicate that the FDA should re-evaluate how long the pens are viable.

People need to keep in mind that the epinephrine in the injectors can degrade more quickly if they're poorly stored, Murphy said. For example, a pen kept in a car can be subjected to high heat in the summer and freezing cold in the winter, which would affect the stability of the drug.

"The reality is, most people don't store their pens under ideal circumstances," Murphy said.

The study appeared in the May 8 Annals of Internal Medicine.

Explore further: Defect prompts Mylan to recall some Epipens

More information: F. Lee Cantrell, Pharm.D., director, California Poison Control System - San Diego division; Andrew Murphy, M.D., allergist, Downingtown, Pa.; May 8, 2017, Annals of Internal Medicine

For more on epinephrine injectors, visit the American Academy of Allergy Asthma & Immunology.

Related Stories

Defect prompts Mylan to recall some Epipens

April 3, 2017
(HealthDay)—Mylan, the maker of the Epipen, says it is recalling "select lots" of the device used to treat dangerous allergic reactions due to a defect that might render it "difficult to activate in an emergency."

Pediatric allergist discusses EpiPen controversy

August 26, 2016
Members of Congress are calling for an investigation into the EpiPen maker Mylan. The pharmaceutical company has increased the price of EpiPens, from about $100 in 2008 to more than $500 today.

EpiPen out-of-pocket costs more than doubled over decade

April 4, 2017
(HealthDay)—Annual out-of-pocket costs for lifesaving EpiPens in the United States skyrocketed nearly 124 percent for many privately insured patients between 2007 and 2014, a new study finds.

The need to replace EpiPens regularly adds to concerns about cost

October 10, 2016
As controversy about the pricing of EpiPens reverberates from Capitol Hill to school districts across the country, one recurring complaint from consumers is that the high cost is magnified because the drug expires quickly, ...

Price rise for anti-allergy EpiPen sparks furor

August 23, 2016
A five-fold price hike for EpiPen, which allergy sufferers use to counteract life-threatening reactions, has made Mylan the newest drugmaker to come under attack in the United States for profiteering.

Top US medical group blasts EpiPen's 'exorbitant' costs

August 24, 2016
The American Medical Association urged the maker of the EpiPen, a life-saving device that counteracts severe allergies, to drop its price Wednesday as public outrage mounted over a soaring cost hike.

Recommended for you

Fighting opioid addiction in primary care—new study shows it's possible

October 18, 2017
For many of the 2 million Americans addicted to opioids, getting good treatment and getting off prescription painkillers or heroin may seem like a far-off dream.

With no morphine, 25 million die in pain each year: report

October 13, 2017
Every year, some 25 million people—one in ten of them children—die in serious pain that could have been alleviated with morphine at just a few cents per dose, researchers said Friday.

Study finds few restrictions on Rx opioids through Medicare

October 9, 2017
Medicare plans place few restrictions on the coverage of prescription opioids, despite federal guidelines recommending such restrictions, a new Yale study finds. The research results highlight an untapped opportunity for ...

Nocebo effect: Does a drug's high price tag cause its own side effects?

October 5, 2017
Pricey drugs may make people more vulnerable to perceiving side effects, a new study suggests—and the phenomenon is not just "in their heads."

Pre-packaged brand version of compounded medication to prevent preterm births costs 5,000 percent more

October 2, 2017
Preventing a preterm birth could cost as little as $200 or as much as $20,000, depending on which one of two medications a doctor orders, according to a new analysis from Harvard Medical School.

Cancer drugs' high prices not justified by cost of development, study contends

September 12, 2017
(HealthDay)— Excusing the sky-high price tags of many new cancer treatments, pharmaceutical companies often blame high research and development (R&D) costs.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.