FDA Removes Last CFC Inhalers from the Market

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ePT--the Electronic Newsletter of Pharmaceutical Technology

After several years of debate and review, the US Food and Drug Administration is calling for the removal of metered-dose inhalers.

Last week, after several years of debate and review, the US Food and Drug Administration called for metered-dose inhalers to be removed from the market. Seven such inhalers, largely used to treat asthma and chronic obstructive pulmonary disease (COPD), use ozone-depleting chlorofluorocarbons (CFCs) to propel the medication into the user’s lungs.

Except for certain uses such as for metered-dose inhalers, the US government eliminated the production of CFCs by early 1996. This measure complies with the international Montreal Protocol, which the US signed in 1987, and the US Clean Air Act of 1990, both of which aim to protect the environment and public health from the potentially negative effects of ozone depletion.

FDA proposed phasing out the seven inhalers-the only remaining CFC-containing products on the market-in 2007, according to an FDA press release. The agency reached a final decision about the products after reviewing more than 4000 public comments and information submitted as part of a public meeting, according to the release. Alternative drug products that do not contain CFCs will remain on the market.

FDA posted a list on its website of the affected inhalers and the last date that each will be manufactured and distributed throughout the US. The list includes Tilade (nedocromil) and Alupent Inhalation Aerosol (metaproterenol), which will be phased out on June 14, 2010. Azmacort Inhalation Aerosol (triamcinolone) and Intal Inhaler (cromolyn) will not be produced after Dec. 31, 2010. Aerobid Inhaler System (flunisolide) will be phased out June 30, 2011. Finally, Combivent Inhalation Aerosol (albuterol and ipratropium in combination) and Maxair Autohaler (pirbuterol) will not be produced after Dec. 31, 2013.


FDA advises patients using the phased-out products to talk to their doctor about switching to an alternative treatment. “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, 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.”

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