The only over-the-counter asthma inhaler sold in the United States soon will be banned from store shelves because of environmental concerns, and replacement medications may cost more, the U.S. Food and Drug administration acknowledged.
The FDA announced on Wednesday that Primatene Mist (epinephrine) will be discontinued by the end of the year, as part of an international agreement to phase out chlorofluorocarbons and other ozone-depleting substances.
Primatene Mist, approved by the FDA for the temporary relief of occasional symptoms of mild asthma, uses chlorofluorocarbons as a propellant.
Many manufacturers have changed their inhalers to replace CFCs with an "environmentally friendly" propellant called hydrofluoroalkane (HFA), but right now, there is no HFA version of the Primatene Mist inhaler.
“There are many other safe and effective medications to treat the symptoms of asthma,” said Dr. Badrul Chowdhury, the director of FDA’s Division of Pulmonary, Allergy, and Rheumatology Products.
The FDA is advising Primatene Mist users – including those who have never had their asthma officially diagnosed -- to see a doctor soon to get another medication.
“If you have breathing problems but have not been diagnosed by a health care professional, it’s important to see one. Not all breathing problems are asthma, so you need to get an accurate diagnosis and the proper medicine,” Chowdhury said.
According to the FDA news release, "Replacement medicines for Primatene Mist may cost more."
The agency offers the following advice to people who can't afford a more expensive medication:
-- Talk to your health care professional about programs that help patients get medicines they need.
-- Contact the company that makes the drug that your health care professional prescribes. The company may have a patient-assistance program that makes medicines available to patients at low or no cost.
-- Contact the Partnership for Prescription Assistance
The FDA anticipates that Primatene Mist will be harder to find on store shelves well before its Dec. 31 discontinue date.
The international agreement that is forcing Primatene Mist off U.S. shelves is called the Montreal Protocol on Substances that Deplete the Ozone Layer.
According to the U.S. Environmental Protection Agency, the treaty is a response to scientists' observations that the earth's protective ozone layer was getting thinner.
"Today, all U.N. recognized nations have ratified the treaty and continue to phase out the production of chemicals that deplete the ozone layer while searching for ozone-friendly alternatives," the EPA says on its Web site.
The FDA’s public discussion about the use of CFCs in inhalers dates back to January 2006. Almost two years later, the FDA finalized the phase-out date for using CFCs in inhalers, and it notified the public in November 2008.