FDA on Wednesday said it is "working to address a shortage of a particular form of albuterol — a medication that is used to treat breathing conditions," and experts warn that the ongoing shortage is expected to worsen.
According to the U.S. National Library of Medicine, albuterol is used to treat individuals who have difficulty breathing or who have lung diseases, including asthma. The medication can be administered in aerosol or powder form at home through an inhaler. However, in more severe cases, patients in the hospital receive liquid albuterol to help them breathe.
In October, FDA declared a nationwide shortage of a liquid form of albuterol. Now, Akorn Pharmaceuticals — one of only two manufacturers of the product — has stopped making the drug after filing for bankruptcy and closing its U.S. facilities.
On March 1, FDA updated its drug shortage page to show Akorn's albuterol inhalation solution is "not available," citing "no new manufacturing of product."
While albuterol can be taken in multiple forms, the aerosolized solution used in a nebulizer in hospitals is in short supply.
Joseph Allen, regional medical director for Premier Health, said at Miami Valley Hospital in Ohio, "we've kind of held back on using it as much for those acute conditions to save it for those folks with asthma that we really need to use it for in emergency situations."
Lurie Children's Hospital spokesperson Julianne Bardele also said staff have been squeezing albuterol out of smaller packages, which is time-consuming and labor-intensive.
This shortage has had the greatest impact on hospital settings, but it can also be an issue for patients who use this form of the drug at home, ABC News reports.
Since last fall, local pharmacies have struggled to keep albuterol on their shelves, and many are concerned that the closure of Akorn's facilities will exacerbate existing challenges.
"The albuterol solution has been in short supply for some time. It's hard to get it in stock," said Jim Stage, pharmacist and owner of Lloyd Pharmacy in Saint Paul, Minnesota. "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."
FDA said 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."
Nephron Pharmaceuticals manufactures a 0.5-milliliter dosage of the liquid albuterol, but it is also in short supply. "We are currently producing Albuterol 0.5 as fast as possible to deliver to the market—and to patients—to address this shortage," said Lou Kennedy, CEO of Nephron Pharmaceuticals.
"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," FDA said on Wednesday. "The FDA continues to explore all available regulatory levers to help assure supply -- including exercising discretion for potential temporary importation by foreign suppliers."
Juanita Mora, an allergist and immunologist at the Chicago Allergy Center and national spokesperson for the American Lung Association, said the ongoing shortage has the medical community "super-concerned."
"It's a medication to save lives and allow people to breath, especially when children, the elderly and also the very sick, can't really use an inhaler," she said.
However, other experts have highlighted alternatives. For example, David Khan, former president of the American Academy of Allergy, Asthma & Immunology, said albuterol inhalers are just as effective as nebulized albuterol. "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," Khan said.
"Don't panic," he added. "A lot of this issue is mainly, I would say, amongst hospitals, and they're looking at other alternative sources for liquid albuterol." For individuals admitted to the hospital or those unable to use an inhaler, levalbuterol may be a viable alternative.
While the drugs are similar, studies have yielded mixed results. For example, a study from 2003 found using levalbuterol instead of albuterol in ED care "significantly reduced the number of hospitalizations."
However, a 2013 meta-analysis suggested that levalbuterol was not "superior" to albuterol in efficacy or safety, and advised against using levalbuterol over albuterol for acute asthma.
Currently, it is unclear if Americans are struggling to fill their albuterol prescriptions. However, a Walgreens spokesperson said the company is still "able to meet patient demand/needs at this time." (Snider, USA Today, 3/9; Kekatos et al., ABC News, 3/9; Lukpat, Wall Street Journal, 3/9)
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