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 have reported difficulty filling prescriptions for Mylan NV’s allergy devices and other auto-injectors containing the active ingredient epinephrine since May 2, James Baker, chief executive officer of patient-advocacy group Food Allergy Research & Education, said in an interview.
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 Inc.’s Meridian Medical Technologies division, which makes the auto-injecting pens for Mylan, was warned by the U.S. Food and Drug Administration for failing to investigate hundreds of complaints about defective EpiPens, including cases where 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,” she said.
Steven Danehy, a spokesman for Pfizer, said in a statement that as a result of new processes put in place after the FDA’s warning letter, “there has been some impact on manufacturing capacity.” He said shipments have increased in recent months and were higher than expected in April.
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 plans to update its shortage website with resources for people looking for EpiPens, Smith Dyer said.
Mylan shares added to losses Tuesday afternoon, and were down 2.4% at 1:58 p.m. in New York. The company is scheduled to report its latest quarterly results on Wednesday.
Word of Mouth
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 Inc. to its comprehensive shortage list on May 3. ASHP tracks drug shortages and attempts to keep the public informed of them.
Whitney Zatzkin, 39, was in the waiting room at her allergist last month in Virginia when she overheard a nurse call around to at least a dozen pharmacies searching for an EpiPen for another patient. The nurse finally found a local pharmacy with one left on the shelf, Zatzkin, founder of the strategy and communications company Rare Dots, said in an interview.
The encounter led Zatzkin to ask for a refill prescription for her daughter’s EpiPen so she could be sure to find one in the next two months before her daughter goes to summer camp.
“A lot of summer camps will only take the yellow-cap EpiPen brand product because they do one type of training,” she said.
Each auto-injector has slightly different instructions for use. Kaleo Inc.’s Auvi-Q auto-injector is still available but many insurers will only cover 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.
The American Society of Health-System Pharmacists has confirmed backorders at Mylan and Amneal, Erin Fox, senior director of drug information at University of Utah Health, which provides data to ASHP for the shortage list. Impax Laboratories, the maker of Adrenaclick, merged with Amneal on Monday.
ASHP determines a shortage exists when patients have to go without or use alternatives, while the FDA doesn’t often classify a product as being in short supply if there are other similar products available, Fox said.
—With assistance from Cynthia Koons and Hannah Recht.
— Read Drug Industry Set Lobbying Records As Pricing Pressure Looms on ThinkAdvisor.