FDA Panel Votes to Ban Primatene Mist for Asthma - Over the Counter (OTC) Sales likely to End

January 25th 2006

Primatene Mist

Over the counter inhalers will be banned if a Food and Drug Administration (FDA) Panel has their way. The ban would not be because the inhalers are dangerous to the user, but because the propellants may harm the ozone layer. This may lead to a ban on Primatene Mist on other similar inhalers.

The advisory panel voted 11-7 to recommend the FDA remove the “essential use” status of the Primatene Mist and other non-prescription inhalers. Since the FDA usually follows their outside panels recommendation, the over the counter (OTC) inhalers will likely be banned completely. It will take a few months before the FDA makes their final ruling but there will be a public comment on the subject.

It is estimated that 3 million Americans use Primatene Mist inhalers, according to the maker of Primatene, Wyeth Consumer Healthcare. Two thirds of the users use a prescription inhaler, but rely on the OTC brands as a backup.

Not all Americans can afford to see a doctor for their asthma. Many have relied on the over the counter medication exclusively. The OTC mists contain epinephrine which opens the air passages to the lungs. These products use chlorofluorocarbons (CFCs) to propel the epinephrine into the lungs.

It is frightening to be unable to breathe. Asthma sufferers experience a shortness of breath as well as trouble breathing when an attack occurs. Some asthma sufferers may keep an OTC product in their car or desk at work just in case they left their prescription inhaler someplace else.

Wyeth has asked the FDA to hold off on their ban until they have an approved alternative to the CFC propellant. It is estimated the new inhalers will be ready for sale by 2009 or 2010.

On a related note, researchers at the Hospital of the University Of Pennsylvania (HUP) are investigating a new thermal treatment for asthma. It is hoped that smoothing the muscle of the airway with a heated bronchoscope will reduce spasms associate with asthma.