Albuterol In Short Supply? FDA Works Closely With Manufacturers To Mitigate Scarcity Of Asthma Drug

An ongoing shortage of albuterol, a drug commonly used to treat asthma and other respiratory illnesses are expected to worsen, leaving the medical community “super-concerned” about the scarcity of the life-saving medicine.

Albuterol is a short-acting bronchodilator that provides relief from an asthma attack by relaxing the smooth muscles in the airways. The drug is also used in the treatment of a range of respiratory illnesses, including influenza, and the relief of COVID-19 symptoms.

The Food and Drug Administration, which has been monitoring the shortage since Oct. 25, 2022, said Wednesday that it is “working closely with manufacturers and others in the supply chain for months to understand, mitigate and prevent or reduce any related impacts.”

Why is there a shortage?

The supply of the liquid albuterol sulfate inhalational solution used in hospitals has been short since last fall, owing to the increase in cases of RSV, flu, and COVID-19, reports said.

“We had millions of children hospitalized with respiratory infections, needing albuterol nebulized for wheezing and coughing. And then you add long-haul COVID and you have an extra population that also uses it,” Dr. Juanita Mora, who works at the Chicago Allergy Center, told USA Today.

Dr.Mora, who is also the national spokesperson for the American Lung Association told the outlet that the medical community is “super-concerned” about the shortage as it is a “medication to save lives and allow people to breathe, especially when children, the elderly and also the very sick, can’t really use an inhaler.”

Around 20 million adults and 5 million children with asthma are expected to face issues with the onset of spring, she added.

Albuterol sulfate used in handheld inhalers for treating asthma and lung diseases does not face a shortage.

The shortage was aggravated after one of the only two U.S. makers of the drug, Akorn Pharmaceuticals, the Illinois-based manufacturer of the drug, shut down last month. The company which was operating under a Chapter 11 bankruptcy filing since 2020 closed its plants and filed for Chapter 7 bankruptcy on Feb. 23.

Now, the only company that manufactures the product, Nephron Pharmaceuticals of South Carolina, is speeding up production.

“We are currently producing Albuterol as fast as possible to deliver to the market — and to patients — to address this shortage,” the company CEO Lou Kennedy told ABC News.

Meanwhile, FDA said they are also considering temporary importation from foreign suppliers to mitigate the shortage. “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. The FDA continues to explore all available regulatory levers to help assure supply — including exercising discretion for potential temporary importation by foreign suppliers,” FDA added.