Wednesday, September 19, 2012

A Farewell to Primatene® Mist (Almost)

In December, 2011, in accordance with its efforts to eliminate sale of CFC-containing inhalers because of the harmful effects of CFCs (chlorofluorocarbons) on the environment, the FDA banned the sale of Primatene® Mist, the over-the-counter (OTC) inhaled bronchodilator containing epinephrine. Suddenly, no low-cost bronchodilator could be purchased in the US without a prescription. The era of Primatene® Mist availability spanned 50 years, and it was estimated that as many as 2-3 million units were sold each year.

Is this a sad or happy farewell? Many would argue that its elimination is a good thing and long overdue. You may remember the headline stories from several years ago about Krissy Taylor, a young model, found dead clutching her Primatene® inhaler. She had self-treated asthma and died not from toxic effects of the medication but from inadequately treated asthma. It is a story that has likely been repeated many times, even if not always with such a tragic and fatal outcome: persons over-relying on bronchodilator therapy, self-treating their asthma without the guidance of a healthcare professional, developing worsening airflow obstruction due to inflammation of the airways (swelling and mucus plugging) while relying on a medication like Primatene® whose only effect is relaxation of the muscles surrounding the bronchial tubes. Making a bronchodilator available at relatively low cost without a prescription makes this scenario all the more possible.

There would be no debate about the benefits of eliminating sale of an OTC bronchodilator were prescription bronchodilators with ozone-friendly HFA (hydrofluoroalkane) propellants available in a low-cost, generic version (which they are not) and were primary care providers readily accessible to all asthma sufferers (which they are not), so that prescription medications could be quickly prescribed and obtained in the context of sound medical advice about asthma treatment. The idea that someone with asthma who is having difficulty breathing might not obtain relief because they cannot get the help of a medical provider and/or cannot afford the cost of a prescription bronchodilator is abhorrent to all. An important first step to solving this problem is once again marketing a generic albuterol (now albuterol-HFA). Inhaled albuterol likely is safer, more potent, with a longer duration of action than epinephrine.

While we engage in reasoned debate on this subject, a pharmaceutical company (Nephron) has found a commercially-driven solution: market a form of epinephrine (racemic epinephrine or racepinephrine) as a liquid delivered by a small hand-held atomizer device. It seems a step back into history, before the invention of metered-dose inhalers, when asthma medications like isoproterenol were delivered using a bulb atomizer. The product (AsthmaNephrin®) and the atomizer device (EZ Breathe®) are already in pharmacies across the country … and available without a prescription. For better or for worse, it appears that the marketplace has won out … again.