Primatene Mist
| Launch year | 1963 |
|---|---|
| Company | Armstrong Pharmaceuticals |
| Availability | Until 2012 |
| Current supplier | Amphastar Pharmaceuticals |
Primatene Mist is a trade name for an epinephrine metered-dose inhaler sold over-the-counter in the United States for the relief of bronchial asthma. It was manufactured by Armstrong Pharmaceuticals,[1] a company based in Canton, Massachusetts and a subsidiary of Amphastar Pharmaceuticals, located in Rancho Cucamonga, California.[2]
Because Primatene Mist contained chlorofluorocarbon, it can no longer be prescribed or sold.[3] This ban was unsuccessfully challenged in the United States Senate in November 2011.[4] An exception to this ban was proposed for inhalers, but was denied. Despite its accessibility, many doctors say the medication wasn't a good option for patients.
Although the CFC ban is what eventually drove Primatene Mist from the market, Pulmonologist have argued for years that it was at the very least, not the best medication for asthma control, and at worst, dangerous. The active ingredient in Primatene Mist is Epinephrine (also known as adrenaline, adrenalin), which can cause a dangerous increase in heart rate.
"Primatene Mist does not treat asthma -- it treats symptoms that can come from asthma," said Dr. Kyle Hogarth, an assistant professor of medicine and the medical director of the pulmonary rehabilitation program at the University of Chicago Medical Center.
The danger in treating only symptoms, he said, is that repeated asthma attacks can permanently damage the lungs. Poorly controlled asthma can progress to a point where, "in their 40s and 50s, [patients] have the lungs of someone who is 80 or 90 who has smoked."
For that reason, the goal of asthma care isn't to react just to attacks -- it's to prevent attacks in the first place. That's generally done with daily medications, such as inhaled corticosteroids, which keep the airways from becoming inflamed. Ideally, Hogarth said, rescue inhalers shouldn't be used more than twice a week, at most. [5]
History
The bronchodilator brand Primatene Mist was introduced in 1963 by Armstrong Pharmaceuticals.[6] In October 2003, Armstrong was bought by Amphastar Pharmaceuticals.[1] In 2008, the Food and Drug Administration (FDA) announced that Primatene Mist inhalers, which contain chlorofluorocarbons (CFCs), failed to comply with the environmental regulations of the Montreal Protocol and therefore could not be manufactured or sold after December 31, 2011.[3] In April 2013, after completing several years of trials,[7] Armstrong Pharmaceuticals submitted a New Drug Application to the FDA for an HFA version of Primatene Mist.[8]
Legislation authored by Senator Jim DeMint to overturn the ban was defeated by the Senate in November 2011 and similar legislation in the U.S. House in December 2012 was also defeated.[4]
OTC Alternatives
- Asthmanefrin
References
- ↑ 1.0 1.1 Background from the Armstrong Pharmaceuticals website
- ↑ Products from the Amphastar Pharmaceuticals website
- ↑ 3.0 3.1 Saundra Young (September 22, 2011). "No more Primatene Mist in the U.S. after this year". The Chart (blog) (CNN). Retrieved 2011-09-22.
- ↑ 4.0 4.1 "DeMint Tries to Halt Ban on Over-the-Counter Asthma Inhaler". Fox News. October 18, 2011.
- ↑ http://articles.latimes.com/2012/feb/13/health/la-he-asthma-inhalers-20120213
- ↑ "Frequent Asked Questions". Armstrong Pharmaceuticals. Retrieved 2011-09-22.
Primatene® Mist was launched in 1963. The Primatene® Mist brand has built a long-time heritage for over-the-counter relief of bronchial asthma.
- ↑ http://clinicaltrials.gov/ct2/results?term=primatene&Search=Search
- ↑ http://www.primatene-mist.us.com/doc/Primatene-HFA-Statement-4-8-13.pdf