Imagine that you have been chosen to serve on a Food and Drug Administration (FDA) Advisory Panel that is being asked to review the application to approve a re-formulated Primatene Mist® for sale over-the-counter. Primatene Mist contains the bronchodilator, epinephrine. For decades it was available without a prescription, with many millions of inhalers sold. It was taken off the market at the end of 2011 because of the general ban on medications using the environmentally-harmful propellant, chlorofluorocarbons (CFCs). Primatene Mist has been redesigned now with the ozone-safe propellant, hyrdrofluoroalkanes (HFAs), and its manufacturer (Armstrong Pharmaceuticals) seeks to have it put back onto the shelves of pharmacies, markets, and convenience stores. How would you vote: “Yay” or “Nay”?
Let’s try to lay out the arguments, for and against approval. We recognize that there are many strongly held opinions on the topic, as a quick read of the “BringBackPrimateneMist” facebook page would suggest.
In favor of approval:
• Many people with asthma do not have a primary care provider to write for them prescription bronchodilators. They too need access to medication that can help their breathing, especially in an asthma crisis. This disparity of access to medication is especially pertinent to asthma, where the poor and minorities bear the greatest burden of the disease. Even some people with health insurance may find an over-the counter medication less expensive, and it can be purchased in a jam, when you discover that you have left your prescription bronchodilator at home.
• Epinephrine by metered-dose inhaler has been used by millions of people over more than 4 decades, suggesting its safety.
• Epinephrine is an effective bronchodilator that begins to work quickly (onset of effect within 1-2 minutes), though with a relatively short duration of effect (1-3 hours).
• Compared to newer (prescription) bronchodilator medications like albuterol (ProAir, Proventil, or Ventolin), epinephrine is more likely to cause heart racing and tremor.
• Selling a bronchodilator over-the-counter means that it can be obtained without medical guidance as to when, how often, and how much to use. Package labeling may carry this information, but more often than not it goes unread.
• An OTC medicine is available for purchase by children without medical or parental guidance.
Primatene Mist sold over-the-counter perhaps made sense in an earlier era when our conception of asthma was a disease of bronchial muscle constriction. Take a bronchodilator medication that relaxes tightened bronchial muscles, open your narrowed airways, and all we be restored to normal. We now know better. Shortness of breath, cough, and wheezing are often due in large measure to allergic (or non-allergic) inflammation of the airways, with swelling of the airway walls and excess mucus production filling the bronchial tubes. Relying on a bronchial muscle relaxer to relieve symptoms leaves much of the cause of the problem untreated. By offering ready access to a medicine that treats only one aspect of asthmatic airway narrowing – temporarily – one invites insufficient treatment, delayed treatment, and the risk of more, not fewer, severe and dangerous asthmatic attacks. It is a step back in time for asthma treatment, not a well-reasoned advance forward. Why would one make an older, less effective bronchodilator available over-the-counter and restrict newer, safer, more effective bronchodilators to prescription only? Perhaps the way forward …in an attempt to make low-cost bronchodilators quickly available to persons who need them … is to make albuterol available over-the-counter in limited doses (for instance, in an inhaler with no more than 20 inhalations per device). The inhaler would provide enough doses to “buy time” while one seeks medical help, not so many that one relies solely on the bronchodilator medication and delays other crucial, potentially life-saving therapies. Of course, one could buy more than one such inhaler at a time, but the message would be clear: the bronchodilator inhaler is for short-term, quick-fix use only.
We recognize that this topic is controversial. Looking for allies to support our point of view, we have found the American Thoracic Society, the American College of Allergy, Asthma, and Immunology, and the American Association of Respiratory Care. We would note that the FDA Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee did meet to discuss Primatene Mist-HFA and voted in February against approval. The FDA has yet to make its final decision.