FDAnews Drug Daily Bulletin

FDA: ALBUTEROL INHALER SHORTAGES REPORTED

March 21, 2006
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The FDA has announced a shortage of albuterol metered-dose inhalers containing both chlorofluorocarbons (CFCs) and the nonozone-depleting propellant hydrofluoroalkane (HFA). Both HFA and CFC inhalers are made by multiple manufacturers, the agency noted.

Starting in early 2006, some manufacturers have had temporary supply shortages of albuterol inhaler products, the FDA said. However, other firms continue to supply the market at previous or increased levels, it added.

"Therefore, albuterol inhaler products continue to be available and additional supplies are anticipated over the next several weeks," the FDA said. Still, supplies of HFA albuterol metered-dose inhalers are anticipated to increase relative to supplies of CFC inhalers over the next several months, the agency added.

"Therefore, HFA inhalers may need to be substituted for CFC inhalers as the shift toward increased HFA inhalers continues to occur," it noted. CFC albuterol inhalers will be completely withdrawn from the market by December 31, 2008, because of their harmful effects on the ozone layer.

"FDA will continue to closely monitor this situation and work with the manufacturers on issues related to increasing supplies," the agency said.