Asthmatic patients who use over-the-counter Primatene Mist will soon need to find an alternative prescription medicine to control their symptoms. The epinephrine drug will no longer be available after Dec. 31.
Approximately 3 million people in the United States rely on Primatene Mist, according to the latest statistics from Amphastar Pharmaceuticals, the company that produces the drug.
However, a few years ago, Primatene Mist came under scrutiny due to environmental concerns, primarily because the inhaler type uses chlorofluorocarbins. The compounds, commonly referred to as CFCs, are known to damage the ozone layer.
In 2006, an FDA advisory panel voted 11-7 that Primatene Mist did not serve an essential health need, and in 2008, they finalized plans to phase the drug out.
The action was a part of an agreement signed by the U.S. and other nations to stop using substances that deplete the ozone layer, which blocks harmful ultraviolet rays from the sun.
Since the FDA’s decision, Amphastar has included information on Primatene Mist’s availability on the company website and the product’s packaging.
Amphastar spokesman Dan Dischner said in a statement that the company is in talks with the FDA about bringing a new, environmentally-friendly version of the OTC drug to the market, but that won’t happen before the current drug is made unavailable.
The principal concern in pulling Primatene Mist and other CFC-driven inhalers off the shelves is the difference in cost between these products and their prescription alternatives.
Currently, Primatene Mist sells for about $20 and is easily available in drug stores and online. Prescription inhalers, which treat the same symptoms but use environmentally-safe hydrofluoralkene, require a doctor’s visit and can cost up to three times as much as the epinephrine version of the drug.
There are also some differences between HFA and CFC inhalers that consumers need to be aware of. These include the need to “prime” an HFA inhaler – in other words, users need to spray a pump or two in the air before administering a pump to themselves, and the need to clean HFA inhalers more often.
Also, some patients who have made the switch say they feel as if they're not getting enough medication because the spray from HFA inhalers does not come out as forcefully.
Easing the transition, the FDA said two other CFC-propelled products, one that uses a combination of ipratropium and albuterol and another that uses pirbuterol, may stay on the market until Dec. 31, 2013.
However, before we start regulating, we have to think about the patients—and as I always like to say, if it ain’t broke, don’t fix it.