FDA Announced EpiPen Shortage. What To Do If You Have An EpiPen Need
On Wednesday morning, the U.S. Food and Drug Administration placed EpiPen, a lower-dose version EpiPen Jr. and Mylan’s generic versions of the products on its list of drugs in shortage.
The FDA said the products were currently available, but that “supply levels may vary across wholesalers and pharmacies.”
"Based on the information provided by the manufacturer, the FDA anticipates the EpiPen shortage to be short-term," an FDA spokesperson said.
The advocacy group Food Allergy Research and Education (FARE) called on the FDA to act swiftly on the growing national shortage of epinephrine auto-injectors.
“Epinephrine is the first-line treatment for anaphylaxis, a serious and potentially life-threatening allergic reaction associated with severe food allergies,” the organization wrote in a press release. “Delayed use of epinephrine during an anaphylactic reaction can lead to death.”
FARE stated the shortage has been felt by patients in almost the entire country, and was not necessarily a “spot shortage.”
So what should you do if your child has an EpiPen need?
Justin Smith, M.D., a pediatrician at Cook Children’s recommends the following:
- Check to see if your prescription is at or near expiring.
- Check multiple pharmacies in your area as some may have it and some may not.
- Check with your pediatrician for alternatives if you can’t find it.
Currently the following epinephrine auto-injectors are available and are not in a nationally declared shortage:
- Auvi-Q Adult (0.3 mg)
- Auvi-Q Child (0.15 mg)
- Auvi-Q Infant (0.1 mg)
According to the kaleo website, patients with prescriptions for Auvi-Q will be enrolled in kaleo’s direct delivery service and AUVI-Q will be shipped directly to you or your doctor's office with the best product dating. Commercially insured patients can get AUVI-Q for $0 out of pocket through the kaleo direct delivery service. For more information call 1-800-30-AUVIQ or visit their website.
The following products are in a nationally declared shortage, according to both the FDA and the American Society of Health System Pharmacists.
- EpiPen (0.3 mg)
- Authorized Generic EpiPen (0.3 mg)
- EpiPen Jr. (0.15 mg)
- Authorized Generic EpiPen Jr. (0.15 mg)
The above products from Mylan Pharmaceuticals are experiencing intermittent supply constraints due to manufacturing delays from the manufacturing partner, Meridian Medical Technologies, a Pfizer company. Mylan is receiving continual supply from MMT and expediting shipment to wholesalers upon receipt. Supply levels may vary across wholesalers and pharmacies. Patients who are experiencing difficulty accessing product should contact Mylan Customer Relations at 800-796-9526 for assistance in locating alternative pharmacies.
- Generic Adrenaclick Adult (0.3 mg)
- Generic Adrenaclick Child (0.15 mg)
The above products from Impax Laboratories are experiencing shortages due to problems with following good manufacturing practices. There is no estimated date for when more product may become available.
Get to know Justin Smith, M.D.
Justin Smith, M.D., is a pediatrician in Trophy Club and the Medical Advisor for Digital Health for Cook Children's in Fort Worth, Texas. Dr. Smith is an experienced keynote speaker for a variety of topics including pediatric/parenting topics, healthcare social media and physician leadership. If you are interested in having Dr. Smith present to your conference or meeting, please contact him at firstname.lastname@example.org.
He has an active community on both Facebook and Twitter as @TheDocSmitty and writes weekly for Cook Children's checkupnewsroom.com. He believes that strategic use of social media and technology by pediatricians to connect with families can deepen their relationship and provide a new level of convenience for both of their busy lifestyles. Dr. Smith’s innovative pediatric clinic, a pediatric clinic “designed by you,” open now. Click to learn more. To make an appointment, call 817-347-8100.