At least 400 people across the U.S. have had trouble getting their hands on an Epipen in recent weeks, according to a survey from the advocacy group Food Allergy Research & Education.
Mylan (NSDQ:MYL), which makes the emergency allergy auto-injector, reportedly told the FDA months ago that manufacturing delays were straining its Epipen supply.
Some patients reported waiting weeks to find the life-saving device, while others were unable to get an Epipen at all, according to a report from Bloomberg.
One day after the survey from FARE was released, the FDA added Mylan’s Epipen to its list of drugs in shortage. The product is still available across the country, the regulatory agency said, but supplies may vary between pharmacies and wholesalers.
The U.S. is not the only country facing an Epipen shortage; similar challenges have cropped up in Canada and the U.K. In Canada, the problem is especially dire, as there are no alternatives to Mylan’s Epipen on the market.
In the U.S., Mylan has few competitors for its allergy device. Privately-held Kaleo makes an epinephrine auto-injector, but many insurers only cover Mylan’s product. Amneal Pharmaceuticals also markets a competing device, but it was included on a shortage list created by the American Society of Health-System Pharmacists, alongside the Epipen.
