A Lesson on Asthma Inhalers, the Ozone Layer, and the FDA

Hopefully by now, asthma sufferers are well aware that as of December 31st of this year, they will no longer be able to purchase Primatene Mist, the only FDA approved over-the-counter inhaler for asthma symptom relief.

First introduced in 1963, Primatene Mist contains CFC (chlorofluorocarbon), a chemical propellant used to effectively disperse the product. CFC was developed in the late 1920’s and was widely used throughout the world in many products including air conditioners and refrigerators, propellants in cleaners, room deodorizers, furniture polishes, hair sprays, perfumes and, unfortunately, in asthma inhalers.

The Ozone Layer

The ozone layer is a protective shield around our planet that absorbs the majority of the sun’s harmful ultraviolet light. In the late 1970’s, CFC’s were shown to cause damage to the earth’s ozone layer. Although a few critics argued that changes in the ozone layer were cyclical and not due to CFC’s, the United States along with 195 other countries signed the Montreal Protocol on Substances That Deplete the Ozone Layer in 1987. The purpose of this treaty was a worldwide phase-out of the use of CFC’s, intended to halt the depletion of our ozone layer.

Whether or not CFC’s were the only cause of the damage to the ozone, according to the UN, one thing is certain… not only has the depletion of the ozone layer completely stopped, but the trend has now reversed itself and is expected to be back to pre 1950’s levels by mid-century.

So, the ozone layer has improved in spite of asthma sufferers using Primatene Mist for the past 40 years. Yet, we’re banning it now.

If CFC’s were the cause of the damage, then the worldwide ban was certainly the right thing to do. However, if someone is using a product containing a CFC to help treat a potentially life-threatening medical condition, and our FDA and pharmaceutical companies knew about this ban over 20 years ago, why are we now down to less than three months remaining with Primatene and still no suitable replacement in an OTC treatment? The FDA advises using a prescription product as an alternative to Primatene that is 200% of the cost. Is now the time to suggest a replacement product that costs twice as much and requires a visit to a physician?

How much additional damage, if any, can asthma sufferers possibly cause to our ozone layer until a suitable OTC replacement is made available? How quickly can the FDA approve something for a change?

Sources:

FDA EPA NASA Huffington Post Clinical Advisor


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