FDA Announces Phase-out of Inhalers using CFCs

The U.S. Food and Drug Administration (FDA) has announced that seven asthma and chronic obstructive pulmonary disease (COPD) metered-dose inhalers that use chlorofluorocarbons (CFCs) as propellants are being removed from the market, in compliance with the Montreal Protocol on Substances that Deplete the Ozone Layer.

Two of the targeted inhalers – the Tilade Inhaler and the Alupent Inhalation Aerosol – are among the first to be phased out. In both cases, their last date to be manufactured, sold or dispensed in the U.S. will be June 14.

According to the FDA, a ban on the general use of CFCs in consumer aerosols has been in effect for decades. Production of CFCs in the United States was eliminated altogether, except for certain limited uses which included metered-dose inhalers.

“During this transition, FDA wants to ensure that patients have access to safe and effective alternative medications to treat their asthma or COPD,” said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in FDA’s Center for Drug Evaluation and Research. “We are currently working with professional societies and patient organizations to make sure patients understand which products will no longer be available and have information on which alternative medication might work best for them.”

The affected products and their phase-out dates are as follows:

• Tilade Inhaler: June 14, 2010
• Alupent Inhalation Aerosol:  June 14, 2010
• Azmacort Inhalation Aerosol: December 31, 2010
• Intal Inhaler: December 31, 2010
• Aerobid Inhaler System: June 30, 2011
• Combivent Inhalation Aerosol:  December 31, 2013
• Maxair Autohaler: December 31, 2013

Alternative medications that contain hydrofluoroalkanes are available to substitute for the CFC-based products. Patients should consult with their physicians to determine which alternative product or products will work best for them in terms of managing their disease in their current lifestyle. Click Here to Access the Full Story from the FDA.