Posted on 10/19/2016 8:15:33 AM PDT by wtd
Mylan CEO Heather Bresch has faced a barrage of criticism from lawmakers and the allergy community over the price escalation of EpiPen sets. But a secondary point she raised during her September 21 testimony in front of the House Oversight and Government Reform Committee was largely overlooked among those who rely on epinephrine auto-injectors: they may soon last longer.
“We hope that within the next 12 months we’ll have approved a new formulation that will extend the shelf life,” Bresch said, while trying to defend the company’s research and development costs.
Mylan confirmed to Allergic Living via email that it would soon be submitting a supplemental New Drug Application to the U.S. Food and Drug Administration that would lengthen the shelf life of EpiPen auto-injectors to 24 months from the current 18 months. (Most patients buy auto-injectors with a somewhat shorter expiry, which relates to distribution and time on pharmacy shelves.)
Such a change would take some of the pressure off people who are paying hefty prices for the life-saving medication, which have risen from $100 for two in 2007 to about $600 today for a two-pack.
“A longer expiry would be great for patients,” says Dr. Julie Brown, an associate professor of pediatrics at the University of Washington School of Medicine in Seattle.
It’s unclear, however, if the company has new data showing that the existing formula of epinephrine and additives in EpiPens can last longer than 18 months, or if it is indeed changing the formula, as Bresch seemed to suggest. When Allergic Living asked for clarification, the company declined to provide more details.
Brown, who has done research on epinephrine stability at extreme temperatures and EpiPen-associated leg lacerations, says either would be possible. She points to a small 2015 study published in the Annals of Asthma, Allergy & Immunology that looked at expired auto-injectors in an allergy practice in Florida. That study showed a predictable decline in epinephrine over time, with greater than 90 percent of the labeled drug dose still present up to two years after expiration.
An earlier study, published in 2000 in the Journal of Allergy & Clinical Immunology, found an estimated 69 percent to 102 percent of the labeled dose present one year after expiration.
“There is the potential for the company to do their own studies and push the expiry date,” says Brown. But since all current and previous auto-injectors contain slightly different additives along with the epinephrine, she says it’s possible the company is planning to make some adjustments to the formula.
An FDA spokesperson told Allergic Living that once a supplemental application is made, the agency targets to have it reviewed in four months.
In the meantime, Brown stresses the importance of making sure your auto-injectors are up to date. “I would never suggest someone carry an expired device,” she says. She recommends always refilling your devices before expiry, and keeping in mind that school nurses or other health-care providers might not administer a device if it has expired.
However, if someone is having a reaction and the only auto-injector that’s available has expired, Brown says to use it. She points to a case in 2013 where a college freshman died from an anaphylactic reaction to a cookie. The mother had an expired device on hand, but she got instructions over the phone from first responders not to use it.
Brown says that while the effect of degradation of epinephrine on health is unknown, “when you are talking about a life-threatening reaction and no alternative options, you are weighing that unknown and likely small risk against the greater risk of not treating.”
If you do have expired devices, Brown says there’s no harm in keeping them as “additional security,” but she cautions they should be clearly labeled as expired and stored so that they don’t get mixed up with the current devices.
If there is visible discoloration of the epinephrine, this indicates degradation, and there is likely a lower concentration of epinephrine in the device. However, there can also be degradation without discoloration, so this is not a reliable way of assessing the strength of the epinephrine, stresses Brown.
Another use for expired auto-injectors: use them for family and friends to practice by injecting them into oranges or grapefruit.
The expiration date and potency is only valid when the epi is stored as directed, 68-77 degrees Fahrenheit, or 77 degrees Mean Kinetic Temperature. Storage outside that range invalidates the expiration date, and is technically illegal to administer because it is adulterated. That’s the ugly little secret that the manufacturers never stress.
Bullcrap. As long as the liquid is still a pale amber color it’s fine. I’ve got some that are 5 years old and there ain’t a thing wrong with them. Manufacturers pull expiration dates out of their backsides.
L
Expiration dates are there only for the lawyers.
Remember the boy who died because his mother refused to give him an injection because the expiration date had just passed? Beyond belief STUPIDITY.
Expiration dates also sell more product.
L
You obviously don’t know anything about pharmaceutical development or pharmacokinetics.
I know bullshit when I smell it.
L
Your intellect is inspirational.
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