CHICAGO — A shortage of EpiPens is alarming patients in Illinois and across the country.
The U.S. Food and Drug Administration added EpiPens and a similar epinephrine autoinjector made by Impax Laboratories to its drug shortage list on Wednesday, after weeks of complaints from patients who say they’ve had a tough time getting them. It’s a shortage the FDA expects will be short-term but one that has patients scrambling and doctors turning to alternatives.
Aimee Weiss, of Highland Park, said her doctor wrote a prescription for multiple packages of EpiPens for her 12-year-old daughter, who’s allergic to tree nuts. But a couple of weeks ago, her CVS pharmacy told her she could only have one pack.
She called a Walgreens store, which told her that her name could be added to a waiting list for the device. She finally got a second pack after spending hours on the phone with her pharmacy and insurer.
However, she usually likes to have four packs, one for her daughter’s backpack, one for school, one for her home and another for her daughter’s dad’s house.
“I’m almost speechless about it,” Weiss said. “It’s not like, ‘Oh, we’re short on a medicine for a headache.’ This is a life-threatening issue.”
EpiPens, sold by Mylan and often used to save the lives of people with severe allergies, are in shorter supply than normal due to manufacturing delays from a Pfizer-owned company that makes the devices for Mylan, according to the FDA’s website.
Mylan said it told the FDA about the issue months ago and remains in contact the FDA about the status of its inventory.
The company is encouraging patients to call its customer relations number at 800-796-9526 to find pharmacies that have the device.
The FDA issued a warning letter to Pfizer in September after inspecting the facility where it makes EpiPens, citing “significant violations” of good manufacturing practice requirements, including a failure to thoroughly investigate problems with product failure associated with patient deaths. At the time, Mylan said the warning letter wouldn’t affect Pfizer’s ability to supply EpiPens.
But Pfizer spokesman Steve Danehy said in an email Wednesday that changes in the manufacturing process implemented in response to that warning letter are partly responsible for the EpiPen supply issues.
At Walgreens, a majority of stores have EpiPens available, Walgreens spokesman Scott Goldberg said in an email. “If a particular store is currently out of stock, other locations may have it available,” he said.
CVS is not experiencing a widespread shortage of epinephrine autoinjectors, though some stores may be temporarily out of stock, CVS Health spokeswoman Amy Lanctot said in an email.
However, James Baker, CEO of the nonprofit Food Allergy Research & Education, said the shortage is far-reaching. Since May 2, more than 400 people in 45 states, including Illinois, have filled out a survey developed by the nonprofit indicating that they’ve had trouble getting EpiPens at their local pharmacies.
There’s also a shortage in Canada and the United Kingdom.
The nonprofit is calling on the FDA to demand Mylan release a timeline showing how it plans to make more supplies available; explore importing a different, similar product made by another company; and work with Mylan and Pfizer to expedite the approval of new production lines or raw materials, among other things.
Baker recommends patients seek alternatives to EpiPens if they can’t get the devices, though patients should make sure to familiarize themselves with how the different devices work. Also, patients may use expired EpiPens if absolutely necessary, he said, though he added that they may be less effective. His nonprofit said patients also should be sure to call 911 and receive medical treatment.
Illinois Allergy and Asthma Specialists in Evanston and Lakeview started noticing a shortage about two weeks ago and has been helping patients who can’t find EpiPens get a different autoinjector, the Auvi-Q, said Dr. Vivian Chou. The device performs the same function.
Stephanie Blumberg, of Deerfield, said her children’s EpiPens don’t expire for months, but she wonders if she should try to get refills now in case the shortage gets worse. Her 9-year-old son and 7-year-old daughter have nut allergies.
“What is going to happen when I need to go refill my EpiPen (prescriptions) and they don’t have them?” Blumberg said. “For kids who do have a severe reaction, they need them on them at all times.”