The short supply of EpiPens is dragging on in the US—and the problem is becoming more worrisome for parents as children prepare to go back to school in the coming weeks.
The US Food and Drug Administration declared a shortage of the life-saving allergy shot in May. The shortfall of the emergency epinephrine treatment has also hit the UK and Canada, and some pharmacies around the US have been unable to restock EpiPens for weeks at a time, according to the Wall Street Journal (paywall).
The issue is now particularly pressing because, for some families, refilling EpiPens is a back-to-school ritual. Demand spikes in August and September, making the scarcity of the medication particularly acute for parents of children with severe allergies.
EpiPens are sold by Mylan and manufactured by Pfizer, which has been unable to produce enough of the medication since an FDA investigation found violations last September at a plant in Brentwood, Missouri, according to Journal. Mylan began a recall on the devices last year, and Pfizer has since been changing its manufacturing process. Pfizer told the Journal in a statement that it’s “working tirelessly to increase production and expedite shipments as rapidly as possible.”
Earlier this week, the FDA extended the expiration date for some EpiPens by four months to help alleviate the shortage. Mylan started a customer service hotline, also posted on the FDA’s website, to help pharmacies and patients locate the medication if needed.
Patients were outraged in 2016 when prices of the treatment soared. Pharmacies used to pay around $100 for a set of two auto-injectors of epinephrine, but the price jumped to more than $600 by 2016, according to a PBS report.
Regulators haven’t been able to alleviate the supply crunch. The FDA approved the first generic versions of the EpiPen a few weeks ago. However the product, marketed by Teva Pharmaceuticals, isn’t available yet; it’s expected to come to the US market in the coming months. A company called Kaleo has also increased manufacturing capacity for a rival EpiPen product, Auvi-Q, to help compensate for the shortage of EpiPens, the Journal said. But some patients are wary of using the alternatives because they’re not covered by insurance, or because their children aren’t familiar with it.