Primatene Mist With CFC To Disappear - Medicine Going Green

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Primatene Mist will not be availble for sale in the United States after December 31, 2011.  Users of Primatene Mist will need a prescription product to treat their asthma.

According to a recent press release from the U.S. Food and Drug Administration (FDA), this over-the-counter asthma inhaler contains chloroflouorocarbons (CFCs) and inhalers containing CFCs will no longer be made or sold after December 31, 2011.

FDA now recommends that users of epinephrine inhalers containing CFCs should plan to get a prescription for a replacement.

Epinephrine inhalers, marketed by Armstrong Pharmaceutical Inc. as Primatene Mist, are the only FDA-approved inhalers for the temporary relief of occasional symptoms of mild asthma that are sold over-the-counter in retail stores without a prescription. The product uses CFCs to propel the medicine out of the inhaler so that consumers can breathe it into their lungs.

Primatene Mist with CFC  
Image credit: DailyMed

According to Armstrong Pharmaceuticals website, they are actively finalizing its internal development of a new, CFC-free Primatene Mist that will continue to use epinephrine as  its active ingredient but will use a more environmentally friendly propellant known as hydrofluoroalkane (HFA). Until this new product is approved by FDA.  They add: there will likely be a period of time between December 31, 2011 and the date of FDA approval of the new HFA Primatene Mist.

Primatene Mist inhalers use CFCs, which decrease the earth's ozone layer. This layer of the atmosphere protects us from some of the sun’s harmful ultraviolet radiation, which can increase the risk of skin cancers and cataracts.

Primatene Mist will no longer be available by year’s end because no CFC-containing epinephrine inhalers can be made or sold after Dec. 31, 2011, to comply with obligations made under the Montreal Protocol on Substances that Deplete the Ozone Layer. This is an international agreement signed by the United States, in which countries agreed to phase-out substances that deplete the ozone layer, including CFCs, after certain dates.

“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 Badrul Chowdhury, M.D., director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

The FDA began public discussions about the use of CFCs in epinephrine inhalers in January 2006. The FDA finalized the phase-out date for using CFCs in these inhalers and notified the public in November 2008. Many manufacturers have changed their inhalers to replace CFCs with the environmentally-friendly propellant called hydrofluoroalkane. There is currently no HFA version of epinephrine inhalers.

According to FDA, there are many other safe and effective inhalers to treat asthma symptoms. All of these inhalers require a prescription, which must come from a licensed health care professional (physician, physician’s assistant or nurse practitioner).

FDA says that Primatene Mist already carries a prominent notice about the phase-out date on its product label, and the FDA encourages Armstrong Pharmaceutical to further educate consumers as the deadline approaches to ensure an incident-free transition. The agency also will continue to work with retailers and pharmacies to facilitate a smooth phase-out of this CFC product and is prepared to review applications for replacement products.

We recommend the FDA web page: Epinephrine CFC Metered-dose Inhalers - Questions and Answers  to those who use Primatene Inhalers.

Source: FDA Press Release

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