Patients nationwide unable to get EpiPens
People in 45 states report difficulty obtaining devices.
Adults and children with severe allergies are experiencing problems finding EpiPens after issues with manufacturing of the lifesaving devices, according to patients and pharmacists.
More than 400 patients in 45 states reported difficulty filling prescriptions for Mylan’s allergy devices and other auto-injectors containing the active ingredient epinephrine since May 2, said James Baker, chief executive officer of patient-advocacy group Food Allergy Research & Education.
Most patients told the group that they haven’t been able to obtain the devices at all, while others said they have had to wait several weeks to get one, Baker said. FARE developed a survey to track problems with accessing allergy-shot devices.
“I don’t know what’s going on,” he said. “I don’t think it’s fair to tell people that are dependent on this medication nothing.”
In September, Pfizer’s Meridian Medical Technologies division, which makes the auto-injecting pens for Mylan, was warned by the Food and Drug Administration for failing to investigate hundreds of complaints about defective EpiPens, including cases in which patients were hurt or died due to faulty injectors.
Mylan told the FDA a few months ago it was experiencing intermittent supply constraints due to manufacturing delays, company spokeswoman Christine Waller said in an emailed statement. Since then, “Mylan and Pfizer have remained in close contact with FDA to provide regular updates on the inventory status.”
Steven Danehy, a spokesman for Pfizer, said in a statement that “there has been some impact on manufacturing capacity” due to processes put in place after the FDA’s warning letter. Shipments have increased in recent months and were higher than expected in April, he said.
The FDA hadn’t added EpiPen to its list of medications in shortage as of Tuesday morning. Companies are required to report shortages to the agency.
“At this time, Mylan is reporting adequate supplies of EpiPen for the U.S. and we will continue to monitor this situation closely,” said Lauren Smith Dyer, a spokeswoman for the FDA. The agency will update its shortage website with resources for people looking for EpiPens.
News of the shortfall has been spreading among allergy sufferers and those who fill their prescriptions.
The American Society of Health-System Pharmacists added epinephrine auto-injectors including EpiPen and a competing product called Adrenaclick manufactured by Amneal Pharmaceuticals to its comprehensive shortage list on May 3. ASHP tracks drug shortages and attempts to keep the public informed of them.
Each auto-injector has slightly different instructions for use. Kaleo’s Auvi-Q auto-injector is still available but many insurers will cover only EpiPen and not Auvi-Q, FARE’s Baker said.
EpiPen supply constraints have been reported in Canada and the U.K. due to manufacturing issues.
“Pfizer anticipates that production rates will increase over the coming months; however, at this time, cannot commit to a specific time for when the supply constraint will be fully resolved,” according to Mylan’s U.K. website for EpiPen.