EpiPens still potent 4 years after expiration date, study says

The active ingredient in auto-injectors like the EpiPen is usually epinephrine, more commonly known as adrenaline, a hormone in which can help relax muscles. the item can open airways along with reduce swelling during a severe allergic reaction.

The cost of the auto-injection devices has gone up 400% since 2007, drawing the ire of patients who rely on them to quickly counter life-threatening reactions. Outrage grew as more insurance providers dropped coverage of the EpiPen.

Amid the criticism, the Mylan developed a cheaper generic alternative priced at $300 For 2 pens.

With these patients in mind, researchers tested devices whose expiration dates had passed to determine whether they were still potent along with safe.

Study author Lee Cantrell, professor of medicine along with pharmacy at the University of California, San Diego, along with his team measured the epinephrine concentration of 40 expired EpiPens along with EpiPen Jrs. They found in which 29 months after expiration, the pens contained at least 0% of their stated amount of epinephrine. Pens 50 months — more than four years — past the printed expiration date had more than 84% of the medication.

“Essentially, all of these would likely still be from the recommended therapeutic range,” said Dr. Thomas Casale, a professor of medicine at the University of South Florida along with executive vice president of the American Academy of Allergy, Asthma, along with Immunology.

The completely new study builds on previous research finding in which epinephrine auto-injectors have a much longer shelf life than labels said. A 2015 study found in which some retained more than 0% of their stated dose two years after expiring.
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Despite the findings, Casale, who was not involved from the completely new study, said patients probably won’t want to take a chance which has a potentially life-saving medication.

“Until those labels are changed, patients are in a bad situation, because they’re concerned about having a life-threatening event along with not having a medicine in which’s effective,” he said.

Both Cantrell along with Casale say in which if someone has an allergic reaction, expired epinephrine is usually better than nothing at all.

“Our paper is usually not suggesting in which people take expired medication,” Cantrell said. “We can’t make in which leap based on our data. yet what we can say is usually in which if you have nothing else, along with you’re having a life-threatening reaction, certainly use the expired epinephrine.”

Life-saving drugs

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“The most common things we would likely prescribe epinephrine for is usually food allergies, bees, wasps along with different stinging insects,” Casale said. “The advantage of these auto-injectors is usually in which you don’t have to think about the item. You just pop the cap, stick the item right in your thigh, the needle comes out at the right depth into the muscle, along with the item delivers the correct amount of epinephrine.”

from the study, all tested auto-injectors were within the therapeutic range for an effective dose. Simply using the amount of time since expiration is usually not always a not bad way to determine whether an EpiPen is usually still potent, along with from the absence of testing equipment, the shade of the solution might give some clues, Cantrell said.

Every pen incorporates a modest window where the liquid medication can be seen. the item’s usually clear along with colorless. The quickest along with easiest indication in which the drug has expired is usually a shade change to brownish-yellow, Cantrell said. “There’s a little window on each one. If the item’s discolored, you shouldn’t use them, period,” he warned.

not bad for backup

yet what if your medication is usually past the printed expiration date along with the shade has not changed? “Personally, I think the item’s fine. I’m not convinced the item becomes dangerous,” Cantrell said.

Merilee Hufnagel, a mother of two in Johns Creek, Georgia, has kept her daughter’s old EpiPens along with says the completely new study validates her belief in which they can still be not bad for a few years. Her 17-year-old daughter has dealt with life-threatening peanut allergies since she was a toddler.

“We’ve been buying them for 14 years. We started off with the EpiPen Jr when our daughter was 3, along with once she hit 60 pounds or so, the doctor switched her to the regular EpiPen,” she said.

Luckily, the Hufnagels have not had to use their auto-injector pens, yet they follow the company’s guidelines along with replace the devices each year.

Merilee Hufnagel keeps her family's expired EpiPens as backups.

However, Hufnagel says she knew in which her expired pens were still not bad along with kept them around just in case. “I keep different ones as backups because I know in my brain in which they’re still fine,” she said.

“The reason I buy completely new ones? I want to be a not bad mom along with follow the recommendations. in which, along with the schools will not accept them if they are expired,” she said.

Although some schools purchase EpiPens, most still require students to provide their own along with register them with the nurse’s office. As with all medications, school policy requires families to update prescriptions along with replace them when they are past their expiration date.

Replacing the pens can be costly. The prescription used to be covered by Hufnagel’s insurance, along with an online co-pay card coming from the company brought the total cost to zero. yet the family’s insurance provider recently stopped covering the name-brand device. To avoid paying $0 out of pocket, they opt for the cheaper generic device.

Mylan, which also makes the generic type, offers co-pay cards in which brought the family’s cost down to $10 For 2 pens. Any additional pens needed would likely be purchased at cost: $300 each.

‘Safe along with effective’

Since the cost controversy began, the shelf life of the auto-injectors has been studied by chemists along with manufacturers alike. When exposed to light, heat or air, the epinephrine can degrade along with lose its effectiveness.

In an emailed statement, Mylan said in which the expiration date is usually the last day the medication is usually “safe along with effective.”

“All epinephrine products have expiration dating whether they come in an auto-injector or vial,” the statement said. “This kind of is usually required by law. An expiration date is usually the final day, based on performed quality control tests, in which a product has been determined to be safe along with effective when stored under the conditions stated from 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 which has a longer shelf life.”

Doctors along with patients rely on information coming from manufacturers for the best information about the safety along with efficacy of their medications.

Most patients like the Hufnagels religiously follow the the’s guidelines, even amid growing evidence about the devices’ potency.

“As far as adverse reactions to medication beyond expiration date, I haven’t see any published study in which shows the item’s truly a danger,” Cantrell said.

EpiPens still potent 4 years after expiration date, study says

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