After hundreds of consumer complaints reached their offices, the US Food and Drug Administration announced they’ll be pulling three full batches of epinephrine from the market, effectively leaving allergic Americans dead in the water.
The drug, also known as L-adrenaline USP, is an ingredient used in a variety of treatments, among which are anaphylaxis and other hypersensitivity reactions that often come with allergies.
Nothing to sneeze at – Epinephrine recalled by FDA
You may have even heard about epinephrine without even knowing it. It’s most commonly sold in autoinjectors known as EpiPens, which people with allergies always have on their person in case of a reaction.
Spectrum Laboratory Products, Inc. Issues Voluntary Worldwide Recall of Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical Ingredient (API) Due to Discoloration of Product https://t.co/CHS86komvq pic.twitter.com/LTkwpJpg8z
— U.S. FDA Recalls (@FDArecalls) January 10, 2023
According to the FDA announcement, any consumers or distributors with epinephrine under the catalog number EP130 should immediately return the product to the place of purchase, where it’ll be replaced with another one from a different batch.
This faulty line of EpiPens was distributed by Spectrum facilities in both the US and Canada; they have the expiration date listed as September 30th, 2023. You can find out more about the labeling of epinephrine products on the FDA’s official website.
The announcement explains the usage of these doses may result in less effective treatment of life-threatening conditions and it is heavily advised against.
— Nei Chan (@NeiChan40105320) January 19, 2023
Quick response curbs a crisis
Despite the reports, Spectrum claims they hadn’t received any complaints regarding their drug; they’re working overtime to notify distributors and customers through e-mail and phone about the faulty product.
This timely response to a faulty batch of EpiPens will help those who need them the most swap them for a fully functional product at the place of purchase. This will end up avoiding a crisis that may happen if there were a shortage of medicine.
For those who suffered from any problems due to the usage of these epinephrin treatments, it is strongly recommended to visit a doctor or a medical professional in the area who can advise on how to progress further.
After this, it is recommended to report on your experiences through the MedWatch Adverse Event page or by filling out a form submitted by a physician.
— US FDA MedWatch (@FDAMedWatch) January 11, 2023
This could’ve easily turned into a much larger issue, seeing as epinephrine is one of the most commonly used treatments in a variety of settings; it’s both medication and a hormone injection.
Unfortunately, this wasn’t the first event of this kind. Only a month ago, the FDA announced a recall of Quinapril, which seemingly had traces of a chemical compound that was causing cancerous growths in some patients’ bodies.
After the discovery, four full lots of Quinapril tablets were removed from the market, even though no actual incidents were reported.
Hundreds of thousands of Americans rely on epinephrine being available. Had the FDA not responded as promptly as they did, we could’ve had a major crisis on our hands.This article appeared in The Record Daily and has been published here with permission.