CFC inhalers to be phased out by end of year, FDA says

Only two CFC inhaler products remain; products to be removed from market by Dec. 31

SILVER SPRING, Md. — The Food and Drug Administration plans to complete its phase out of inhalers that contain ozone-depleting chlorofluorocarbons by the end of the year, the agency said Wednesday.

The FDA said it planned to complete the phase-out of all CFC inhalers by Dec. 31 in order to comply with international treaties. CFCs are propellants used to help patients inhale medicines, but they also deplete the ozone layer, and the United States was a signatory to the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer, along with most other countries. CFCs have since been removed from hairsprays, deodorants and air conditioning.

Most of the products containing CFCs have already been phased out, and currently, only two remain on the market: Boehringer Ingelheim's Combivent (ipratropium bromide; albuterol sulfate) and Medicis' Maxair (pirbuterol). The albuterol CFC inhaler, the most commonly used one, was phased out in 2008 and replaced with inhalers that use propellants called hydrofluoroalkanes, or HFAs. BI has another inhaler with the sale active ingredient, Combivent Respimat (ipratropium bromide; albuterol) that uses a mechanical propellant system.

Inhalers are most often used by people with asthma or chronic obstructive pulmonary disease — a term that encompasses chronic bronchitis and emphysema — which respectively affect 25 million and 15 million people in the United States.

"CFCs were used as propellants to move the drug out of inhalers so that patients can inhale the medicine," FDA director of the Division of Pulmonary, Allergy and Rheumatology Products Badrul Chowdhury said. "For more than two decades, the FDA and Environmental Protection Agency have collaborated to phase-out CFCs in inhalers, a process that included input from the public, advisory committees, manufacturers and stakeholders."

 

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