23 September 2011

FDA bans CFCs in some inhalers

Health officials are banning the only asthma inhaler sold over the counter in the United States starting next year to prevent the use of products that harm the environment.


Health officials are banning the only asthma inhaler sold over the counter in the United States starting next year to prevent the use of products that harm the environment.

The Food and Drug Administration said that chlorofluorocarbons (CFCs) in metered-dose asthma inhalers that contain the drug epinephrine cannot be used, following an international agreement that bans CFCs because they deplete the Earth's ozone layer.

Right now, the only such inhaler is marketed by Armstrong Pharmaceuticals, a unit of Amphastar. The company could not be immediately reached for comment.

The inhaler, called Primatene Mist, is used for temporary relief of occasional symptoms of mild asthma and is the only FDA-approved inhaler sold over the counter without a prescription, the FDA said.

Millions use primatene mist

The product uses CFCs to propel medicine out of the inhaler so patients can breathe it into their lungs. The FDA said some manufacturers now use a propellant called hydrofluoroalkane instead, which is less harmful to the environment.

The FDA first proposed phasing out the use of CFCs in asthma inhalers with epinephrine in 2006, and finalized the phase-out in November 2008.

Primatene Mist inhalers are already labelled to show they cannot be used after Dec. 31, 2011. After that, the FDA said, some consumers may have to pay more for prescription asthma inhalers.

About one million to two million patients use Primatene Mist, although it is difficult to get an estimate of how many people use over-the-counter drugs, the FDA said.

Most common chronic disease

More than 235 million people worldwide suffer from asthma and it is the most common chronic disease among children, according to the World Health Organization.

Two other prescription asthma inhalers that use CFCs are to be phased out by the end of 2013. These are Boehringer Ingelheim's Combivent Inhalation Aerosol and Graceway Pharmaceuticals' Maxair Autohaler.

The United States has generally banned CFCs in consumer products such as hairspray since 1978, but their use has been permitted in medical products when the FDA deems it essential.

(Reuters Health, September 2011) 

Read more:



Read Health24’s Comments Policy

Comment on this story
Comments have been closed for this article.

Ask the Expert

Asthma Expert

Professor Keertan Dheda has received of several prestigious awards including the 2014 Oppenheimer Award, and has published over 160 peer-reviewed papers and holds 3 patents related to new TB diagnostic or infection control technologies. He serves on the editorial board of the journals PLoS One, the International Journal of Tuberculosis and Lung Disease, American Journal of Respiratory and Critical Medicine, Lancet Respiratory Diseases and Nature Scientific Reports, amongst others.Read his full biography at the University of Cape Town Lung Institute

Still have a question?

Get free advice from our panel of experts

The information provided does not constitute a diagnosis of your condition. You should consult a medical practitioner or other appropriate health care professional for a physical exmanication, diagnosis and formal advice. Health24 and the expert accept no responsibility or liability for any damage or personal harm you may suffer resulting from making use of this content.

* You must accept our condition

Forum Rules