Dawn Crisostomo’s 10-year-old son has life-threatening allergies to peanuts, and she usually purchases three boxes of EpiPens each year: one for home, one for school and one that he can carry with him. The EpiPens are sold in sets of two, in case one isn’t enough to open the airways during an acute allergic reaction.
But when Ms. Crisostomo went to refill her son’s prescription two weeks ago, her pharmacist said there was a nationwide shortage, then tore open a boxed set and offered her a single EpiPen.
“He said, ‘I’m sorry, we literally only have five in stock right now, we can only give you one,’” said Ms. Crisostomo, of Tacoma, Wash. “It’s kind of scary.”
On Wednesday, months after consumers around the country started reporting that they couldn’t purchase EpiPens to treat severe allergic reactions, the Food and Drug Administration announced there were shortages of two brands of epinephrine auto-injectors, including EpiPens, sold by the drug company Mylan, and Adrenaclick auto-injectors, made by Impax Laboratories.
Another brand of epinephrine auto-injector, called Auvi-Q, is available, but may not be covered by some insurance policies. All these devices deliver a lifesaving dose of epinephrine, a drug that narrows blood vessels, opens the airways in the lungs and helps stop the dangerous cascade of events that can prove fatal during a severe allergic reaction.
The F.D.A. attributed the shortages to manufacturing problems, but the agency has not been able to provide any clear information or timeline about when the shortage will ease.
“This is a continuously evolving and fast-moving issue,” Lauren Smith, an F.D.A. spokeswoman, said in a statement. “Multiple factors have resulted in limited availability of EpiPen in certain areas in the U.S., including both pharmacy-level supply disruptions and a manufacturer issue.” She said that based on information provided by the manufacturer, the F.D.A. anticipates the issue to be “short-term.”
A statement released by Mylan said the company informed the F.D.A. “a few months ago” of “intermittent supply constraints.” The company has come under attack from consumers in recent years after increasing the price of EpiPen sixfold since buying the product in 2007.
Patient groups have challenged the description of shortages as intermittent, with consumers from 46 states reporting to Food Allergy Research & Education, a nonprofit advocacy group that focuses on food allergy issues, that they were unable to fill EpiPen prescriptions.
Complaints included consumers who have been trying to find EpiPens in Seattle since March to no avail, patients who said their EpiPen had expired and they are currently without one, patients who were repeatedly told the drug is on “back-order,” and one who reported trying 10 pharmacies before finding an EpiPen.
Linnea Clary, who lives in York, Me., said her son’s EpiPens expired in February and she had been unable to refill the prescription, despite trying different pharmacies, including one at a large hospital in Boston. “I can’t fill it, period,” she said.
Mylan is encouraging consumers who are unable to fill an EpiPen prescription to call its customer service line at 800-796-9526 between 8 a.m. and 5 p.m. Eastern Time for assistance in locating a pharmacy that has the product in stock.
FARE has called on the F.D.A. and the Department of Health and Human Services to notify both the general public and health care providers of the shortages, and to inform insurers they may need to cover alternative medications.
The organization is urging the F.D.A. to take steps to alleviate the shortage, either by expediting reviews of new generic epinephrine auto-injectors or importing other products.
“This is a life and death issue for people with systemic allergic reactions,” said Dr. James Baker, FARE’s chief executive and chief medical officer. “If you have one of these attacks, the only thing you can do to keep yourself from going into shock is to give yourself the epinephrine and then get to the emergency room. And if you don’t have it, you may not make it to the emergency room.”
The shortage is not unique: dozens of drugs are on the F.D.A.’s list of medication shortages, including injectable anesthesia agents, pain medications, penicillin, feeding and hydration solutions, heart disease drugs, and even simple products like sterile water.
Consolidation in the pharmaceutical world has diminished the number of manufacturing plants, so production problems at a single site can have tremendous repercussions, said Michael Ganio, director of pharmacy practice and quality at the American Society of Health-System Pharmacists.
Back in September, the F.D.A. warned Pfizer’s Meridian Medical Technologies, the manufacturer of Mylan’s EpiPens and EpiPen Juniors, that its Brentwood, Mo., plant was in violation of good manufacturing practices and that it had failed to investigate serious product failures “associated with patient deaths and severe illness.”
It was not the first time the F.D.A. had cited the company for violations, and the letter noted that the company’s own data revealed it had received hundreds of complaints about EpiPens failing during life-threatening emergencies.
A Pfizer spokesman said Wednesday that the manufacturer had increased its shipments in recent months, but said the problem resulted from shortages of “certain third-party components, along with process changes implemented which have temporarily limited capacity at our manufacturing facility.”