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OTC Asthma Inhalers Containing CFCs Phased Out By Year End, Prescription Needed for Replacement Products
FDA reminds consumers using over-the-counter (OTC) asthma inhalers containing chlorofluorocarbons (CFCs) that the products will no longer be made or sold after December 31, 2011. Consumers should plan now to obtain a prescription for a replacement product, FDA advises. The phase out of the products is being implemented to comply with obligations made under the Montreal Protocol on Substances that Deplete the Ozone Layer, an international agreement signed by the United States. FDA explains that epinephrine inhalers – marketed by Armstrong Pharmaceutical Inc, such as Primatene Mist – are the only OTC FDA-approved inhalers for the temporary relief of occasional symptoms of mild asthma, and that the product uses CFCs to propel the medication. Primatene Mist already carries a prominent notice about the phase-out date on its product label, and FDA has encouraged Armstrong Pharmaceutical to further educate consumers. Following public discussions, “the FDA finalized the phase-out date for using CFCs in [epinephrine] inhalers and notified the public in November 2008. Many manufacturers have changed their inhalers to replace CFCs with an environmentally-friendly propellant called hydrofluoroalkane (HFA). There is currently no HFA version of epinephrine inhalers.” FDA advises that there are many other safe and effective inhalers to treat asthma symptoms, and that these products require a prescription. More information is available in an FDA news release.
