FDA WARNING ABOUT EPIPEN MALFUNCTIONSIn March 2020, the Food and Drug Administration (FDA) released a
safety alertto warn the public that epinephrine auto-injectors (EpiPen, EpiPen Jr, and generic forms) may malfunction. This could prevent you from receiving potentially lifesaving treatment during an emergency. If you’re prescribed an epinephrine auto-injector, see recommendations from the manufacturer hereand talk with your healthcare provider about safe usage.
Daisy Vidal Marc’s 6-year-old son hasn’t used a single dose of epinephrine yet for his peanut allergy, but shortages and the price of the EpiPen injector have still affected her family.
“The cost of an EpiPen is absurd,” Vidal Marc told Healthline. “I hope a generic will allow for more options to get EpiPens filled and with better pricing.”
That leaves families like Vidal Marc’s scrambling for solutions as school kicks back in session.
“We were unable to replace an expired set of EpiPens for the new school year, and after waiting about a month for it to be filled, the allergist suggested we get AUVI-Q instead,” said Vidal Marc. “We were able to get a set in time for school and quickly with Kaléo. There was a real concern over my son starting school without a set of epinephrine at school.”
Shortages mean that being prepared with lifesaving medication isn’t always possible.
The FDA’s recent approval of the first generic EpiPen is an attempt to fix the cost and supply issue, but some parents are skeptical.
The cost for patients and parents
“For the 15 million Americans with life-threatening food allergies, access to epinephrine medication is a matter of life and death,” Kenneth Mendez, president and chief executive officer of The Asthma and Allergy Foundation of America told Healthline. “Given the recent shortages of this medication, having access to another option is good news. However, the FDA’s announcement won’t solve the current shortage of epinephrine, and patients are getting shortchanged.”
A set of two EpiPens costs around $700. Many families don’t have insurance coverage for the product. Parents aren’t convinced the generic will help with current shortages or cost.
“I can’t imagine it will help with the current shortage. They would need to produce them very quickly. I’m thankful there is the new AUVI-Q on the market that was readily available and we were able to get a set filled,” Vidal Marc said.
Like Vidal Marc, Smith wants to see more reasonable pricing for patients.
“I would love for the generic to cost no more than $50. With Auvi-Q, we are currently paying zero dollars, which is lovely,” Smith hold Healthline.
The cost of the new generic has not yet been released.
Advice for parents
There are some obstacles to overcome in using the generic auto injector.
For one, families switching to the generic will need to remove two safety caps instead of one.
It sounds minor, but the adjustment could leave some parents and children feeling unprepared.
Using auto-injectors can induce anxieties in parents and children, but, Vidal Marc said, “being able to practice with a trainer makes a big difference... The trainer also allows a parent to train their child how to self-administer if they are old enough and ever need to.”
The Allergy & Asthma Network recommends people “be trained on the device they receive from their pharmacy to ensure they understand the proper way to use it in an emergency.”
How the generic compares
An EpiPen treats life-threatening adverse reactions to food, medication, insect stings and bites, and exercise.
It opens airways, calms digestive muscles, and reverses dangerous decreases in blood pressure.
The generic version does exactly the same, but in different packaging.
FDA officials say the devices are “therapeutically equivalent,” and “generic drug-device combination products, such as the generic epinephrine injection (auto-injector), need not be identical to the brand-name product in all aspects.”
Smith told Healthline the generic is not enough.
“I would like to see multiple alternatives to the EpiPen besides just a generic,” she said. “I think the market is ripe for an auto-injector that is sleeker and that has an expiration date longer than just 12 months into the future.”
The generic will be available in both adult and junior dosing.
Parents and patients can get the generic version from their local pharmacy, but neither the manufacturer Teva nor the FDA have confirmed when.
Protecting people while we wait
In the meantime, back-to-school shortages loom.
The Asthma and Allergy Foundation of America suggests several ways insurers and manufacturers can help families stay safe:
- Insurers must fill prescriptions for pairs or twins of epinephrine auto-injector (EAIs) and not split the prescription in half.
- Insurers (including Medicare) must offer coverage for any EAI. If the EAI that is covered by their formulary is not available due to shortages, they should make an exception and cover other products for their patients.
- Insurers must allow refills to cover more than one pair of EAIs in a 30-day period. This allows families to properly stock emergency medications at the beginning of the school year.
Manufacturers must be diligent to maintain supply in advance of back-to-school season.