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No more Primatene Mist in the U.S. after this year
September 22nd, 2011
01:56 PM ET

No more Primatene Mist in the U.S. after this year

The Food and Drug Administration is reminding doctors and patients that Primatene Mist, the only nonprescription asthma inhaler in the United States, can no longer be sold or prescribed after December 31.   Asthma patients are urged to get prescriptions for alternative medications, since this treatment option runs out at the end of the year, the FDA said Thursday.

Primatene Mist, an epinephrine inhaler, made by Armstrong Pharmaceutical Inc., contains chlorofluorocarbons, a chemical known to deplete the ozone layer.   After the United States signed an international agreement - The Montreal Protocol on Substances that Deplete the Ozone Layer - to phase-out the compounds, the FDA announced in 2008,  that these inhalers could not be made or sold in 2012.

"If you rely on an over-the-counter inhaler to relieve your asthma symptoms, it is important that you contact a health care professional to talk about switching to a different medicine to treat your asthma," said Dr. Badrul Chowdhury, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.

Chlorofluorocarbons are chemicals that contain fluorine, chlorine, and carbon. With inhalers, they are used as a propellant to move the medication, helping the user to breathe it in. According to The National Library of Science at the National Institutes of Health, once released, the odorless, colorless and nontoxic compounds get into the Earth's atmosphere where they break apart and release chemicals that destroy the Earth's ozone layer. CFCs can last more than 100 years in the atmosphere.

The FDA says a number of manufacturers have already replaced their CFC inhalers with a propellant called hydrofluoroalkane  or HFA, which is more environment-friendly, but there's currently no HFA version of an epinephrine inhaler available. Epinephrine is a hormone that's used to treat life-threatening allergic reactions. It opens up the airways in the lungs and allows patients to breathe more easily.

CFCs have been used in products like refrigerators, air conditioners, cleaning products and aerosols since the 1930s. Those products with CFCs were banned in the U.S. in 1995. They've been used in inhalers since the 1980s.

Chowdhury says asthma patients can continue using an inhaler that's not empty by the December 31 deadline as long as the expiration date is still good. He says HFA inhalers are safe and effective, but warns they may taste and feel different. "Talk with your health care professional to make sure you are using it correctly and getting the correct dose."

According to Chowdhury there are two prescription inhalers that still use CFCs. Those products are also part of the international agreement and they have phase-out dates of December 31, 2013.


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