Nationwide shortage of asthma medication albuterol could worsen in hospitals
FDA says there is no shortage of asthma medication inhalers for personal use.
A nationwide shortage of the asthma medication albuterol has been ongoing since last fall and experts fear it's only expected to get worse.
Albuterol can be taken in several forms but it's the aerosolized solution used in a nebulizer in hospitals that the U.S. Food and Drug Administration put on its drug shortage list in late October. This shortage poses the greatest challenge for hospital settings where it is used most commonly but can be a problem for those that use this form of the drug at home.
This shortage only impacts a very specific dosage form of the medication generally used in hospitals. The FDA says it has been "working closely with manufacturers and others in the supply chain for months to understand, mitigate and prevent or reduce any related impacts."
Although it's not clear what prompted the initial constrained supply, the FDA has been tracking the shortage.
Generic drug manufacturer Akorn Pharmaceuticals filed for Chapter 7 bankruptcy last month, according to documents viewed by ABC News, and reportedly closed its U.S. facilities, knocking out one maker of albuterol.
The FDA updated its drug shortage page on March 1 to show Akorn's albuterol inhalation solution is "not available" due to "no new manufacturing of product."
This leaves Nephron Pharmaceuticals, based in South Carolina, as one of the only remaining primary manufacturers of liquid albuterol.
"We are currently producing Albuterol as fast as possible to deliver to the market -- and to patients -- to address this shortage," Nephron CEO Lou Kennedy told ABC News.
In a statement posted online Wednesday night, the FDA said, in part, that it's "working to address a shortage of a particular form of albuterol -- a medication that is used to treat breathing conditions. It is important to note that this shortage does not impact albuterol inhalers for personal use."
"We recognize the potential impact that intermittent availability of certain drug products can have on providers & patients. To help meet demand, FDA has reiterated that outsourcing facilities may compound the specific product that's in shortage to help increase supply," it continued, in part. "The FDA continues to explore all available regulatory levers to help assure supply -- including exercising discretion for potential temporary importation by foreign suppliers."
Local pharmacies said they have been struggling to stock albuterol over the past few months and are worried the closure of Akorn facilities will make it harder.
"The albuterol solution has been in short supply for some time. It's hard to get it in stock," Jim Stage, owner of Lloyd Pharmacy in Saint Paul, Minnesota, and a pharmacist, told local ABC affiliate KSTP. "We're checking secondary and tertiary vendors if our primary vendor doesn't have it, so it's just creating a little bit more legwork on our part."
What is albuterol?
Asthma is an inflammatory disease that causes airways in the lungs to constrict and prevents normal breathing. It affects more than 25 million Americans, according to the Centers for Disease Control and Prevention.
Albuterol is a medication that helps open these constricted airways. It works by activating the beta receptors in the lungs, which helps the airways open and relax so asthma sufferers can breathe more easily.
Inhaled albuterol can be given through an inhaler or as an aerosolized solution through a nebulizer machine. The aerosolized solution is the type currently facing a national shortage.
This solution is sometimes used at home for infants and young children who have difficulty using an inhaler, but it is used most commonly in hospital settings to treat a range of breathing problems associated with wheezing that includes asthma and some respiratory infections.
"This is a lifesaving medication that we need to have on demand and available when patients needed," Dr. Juanita Mora, national volunteer medical spokesperson for the American Lung Association, told ABC News.
Mora said she has witnessed how distressing this shortage has been for her patients and families and warned that the pollen season is around the corner.
"As pollen levels rise, they are a huge trigger for asthma. I want to make sure that everyone's asthma COPD emphysema long-haul COVID is well optimized before we head into that season," Mora said.
Are there alternatives?
"Don't panic," Dr. David Khan, past president of the American Academy of Allergy, Asthma & Immunology, told ABC News. "A lot of this issue is mainly, I would say, amongst hospitals, and they're looking at other alternative sources for liquid albuterol."
Khan explained that the albuterol inhalers are just as effective as nebulized albuterol, adding, "I think this is a common misconception. Patients just generally need to use a little bit more puffs of their Albuterol inhaler, and it'll work the same as the nebulizer machine."
For patients admitted to the hospital, or infants unable to use an inhaler, one alternative medication to albuterol is levalbuterol.
Although similar, studies have had mixed results. One study from 2003 found substituting levalbuterol for albuterol in emergency department care "significantly reduced the number of hospitalizations."
However, a meta-analysis in 2013 showed levalbuterol was not "superior" to albuterol regarding efficacy and safety, and suggested not using it over albuterol for acute asthma.
It's unclear if every day Americans are having trouble filling prescriptions. A Walgreens spokesperson told ABC News it is "able to meet patient demand/needs at this time."
Other pharmacy chains including CVS Health, Rite Aid Corp., Kroger Inc. and Albertsons Inc. did not return ABC News' request for comment.