FDA phasing out certain inhalers

Seven Inhalers That Use CFCs Being Phased Out

The U.S. Food and Drug Administration announced seven metered-dose inhalers (MDIs) 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. FDA noted that alternative medications that do not contain CFCs are available.

The affected products along with the final date that they will be manufactured, sold, or dispensed in the United States include: Tilade Inhaler (nedocromil) by June 14, 2010; Alupent Inhalation Aerosol (metaproterenol) by June 14, 2010; Azmacort Inhalation Aerosol (triamcinolone) by Dec. 31, 2010; Intal Inhaler (cromolyn) by Dec. 31, 2010; Aerobid Inhaler System (flunisolide) by June 30, 2011; Combivent Inhalation Aerosol (albuterol and ipratropium in combination) by Dec. 31, 2013; and Maxair Autohaler (pirbuterol) by Dec. 31, 2013.

FDA said that patients currently using these inhalers 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.

The agency noted the phase-outs are in accordance with longstanding U.S. obligations under the Montreal Protocol on Substances that Deplete the Ozone Layer. 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 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 originally 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.

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