FDA Recommends Ban of Non-Prescription Inhalers

I remember back in the 1980s I used to use those Primatene Mist inhalers for my asthma over the counter not knowing the dangers but back then I probably wouldn’t have cared.

Years later I also remember hearing about a model that died from using the same brand of inhaler.

Ever since I warn people about them and I’ve been on prescription inhalers since 1992.

On Jan. 25th a Food and Drug Administration (FDA) panel recommended the ban on some non-prescription inhalers used to treat asthma because the devices contain propellants that harm the protective ozone layer.

The FDA advisory panel voted 11-7 to remove the “essential use” status that Primatene Mist and other similar nonprescription inhalers require to be sold.

The over-the-counter inhalers proposed to be banned contain the drug epinephrine along with chlorofluorocarbons or CFCs, which propel the medicine into the lungs of people with asthma.

“This system is made for only two people – the wealthy and the really poor,” said a woman who cares for her elderly father who is on oxygen.

The American Lung Association has stated that they agree with the FDA recommendation because it protects the environment and removes an over-the-counter substitute that has more side effects than prescription medications.

In March 2005 the FDA said inhalers using CFCs to dispense the prescription drug albuterol would be banned at the end of 2008.

In other business in a letter to Congress, the American Lung Association’s President & CEO John Kirkwood stated that: “The American Lung Association is very concerned about provisions changing the Medicare home oxygen service that are included in S. 1932, The Deficit Reduction Act of 2005.”

In the letter Kirkwood said that an estimated one million Americans have medical conditions that require the use of supplemental oxygen to engage in activities of daily living.

“The provision in question requires the transfer of ownership of oxygen equipment including portable oxygen equipment to the patient after 36 months of continuous use,” said Kirkwood. “The American Lung Association is deeply troubled that Congress is acting precipitously without enough information to inform lung disease patients of the impact of these proposed changes?”

According to comments by the Association concerning the Department of Transportation’s (DOT) proposed rulemaking: “The Federal Aviation Administration (FAA) has recently paved the way for permitting portable oxygen concentrators on airlines once the devices are tested and proven to not interfere with communication and navigation systems.

In a letter to the Office of the Assistant General Counsel for Aviation Enforcement and Proceedings at the DOT, Kirkwood wrote that the Association supports the proposed rulemaking to require all airlines, both domestic and foreign carriers, to accommodate people with respiratory disabilities if the aircraft carries more than 60 people.

“Further, the airlines should be required to accommodate individuals using these devices including allowing passengers to carry extra batteries on board and giving them priority access to seating with electrical outlets,” he added. “Steps such as those outlined here are greatly needed to improve access to air travel for people who require supplemental oxygen.”

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