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FDA Says Asthma and COPD Inhalers That Contain Ozone-depleting CFCs to be Phased Out; Alternative Treatments Available


4/14/2010 8:15:17 AM

SILVER SPRING, Md., April 13 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced, in accordance with longstanding U.S. obligations under the Montreal Protocol on Substances that Deplete the Ozone Layer, seven metered-dose inhalers (MDI) used to treat asthma and chronic obstructive pulmonary disease (COPD) will be gradually removed from the U.S. marketplace. These inhalers contain ozone-depleting chlorofluorocarbons (CFCs), which are propellants that move medication out of the inhaler and into the lungs of patients. Alternative medications that do not contain CFCs are available.

The affected products and their phase out schedule include:

Patients using the inhalers scheduled to be phased out should talk to their health care professional about switching to one of several alternative treatments currently available. Until then, patients should continue using their current inhaler medication.

"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 decision to phase out the products is the latest in a series of decisions related to the removal of CFC inhaler products from the market as required by the Clean Air Act. The agency proposed to phase-out the seven remaining products in 2007 and reached a final decision after reviewing more than 4,000 public comments and information submitted as part of a public meeting.

Seven Inhalers That Use CFCs Being Phased Out

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm207864.htm

Metered-Dose Inhalers Clean Air Act Information

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm071523.htm

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


CONTACT: Erica Jefferson of the FDA, +1-301-796-4988,
erica.jefferson@fda.hhs.gov

Web site: http://www.fda.gov/



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