Wednesday, April 14, 2010

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

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:
Inhaler Medication
Last Date to be manufactured, sold or dispensed in U.S.
Manufacturer

Tilade Inhaler (nedocromil)
June 14, 2010
King Pharmaceuticals

Alupent Inhalation Aerosol (metaproterenol)
June 14, 2010
Boehringer Ingelheim Pharmaceuticals

Azmacort Inhalation Aerosol (triamcinolone)
Dec. 31, 2010
Abbott Laboratories

Intal Inhaler (cromolyn)
Dec. 31, 2010
King Pharmaceuticals

Aerobid Inhaler System (flunisolide)
June 30, 2011
Forest Laboratories

Combivent Inhalation Aerosol (albuterol and ipratropium in combination)
Dec. 31, 2013
Boehringer Ingelheim Pharmaceuticals

Maxair Autohaler (pirbuterol)
Dec. 31, 2013
Graceway Pharmaceuticals





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.

CFCs are harmful because they deplete the ozone layer miles above the Earth that absorb some of the sun's harmful ultraviolet rays. The United States has banned the general use of CFCs in consumer aerosols for decades, and eliminated the production of CFCs in the United States as of Jan. 1, 1996, except for certain limited uses, such as MDIs.

"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 CFC phase out is part of an international agreement to ban substances that deplete the Earth's ozone layer. The Montreal Protocol on Substances that Deplete the Ozone Layer and the U.S. Clean Air Act aim to protect the public health and the environment from the potentially negative effects of ozone depletion. Bans on products containing CFCs began in the late 1970s.

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.

For more information:
Seven Inhalers That Use CFCs Being Phased Out
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm207864.htm
Phase-Out of CFC Metered-Dose Inhalers Containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm193896.htm
Metered-Dose Inhalers Clean Air Act Information
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm071523.htm
Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease that Do Not Use Chlorofluorocarbons
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm082370.htm
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

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