Primatene Mist Asthma Inhaler No Longer Sold After Dec. 31, 2011

Primatene Mist is the only OTC inhaler used to treat mild asthma that is sold in the United States. But after Dec. 31, 2011, the epinephrine inhalers will no longer be available to American consumers.

The inhalers are being phased out because they use chlorofluorocarbons, or CFCs, as a propellant. The use of CFCs does not comply with the Montreal Protocol on Substances That Deplete the Ozone Layer, an international agreement that requires the phase-out of products and substances that diminish the protective ozone layer surrounding the Earth.

During a Sept. 22 news conference, Andrea Leonard-Segal, M.D., director of the Division of Nonprescription Clinical Evaluation in the FDA's Center for Drug Evaluation and Research, advised health care professionals to talk with their patients about the phase-out and the replacement products that would be available.

"There is an alternative FDA-approved product available with a prescription," said Leonard-Segal. "Albuterol HFA (hydrofluoroalkane) inhalers are prescription inhalers that are used in very much the same way as epinephrine CFC inhalers, and they are safe and effective."

The process of switching patients to a different medication should begin now, she noted, because if patients start to buy up available supplies of the medication, "Primatene Mist may be harder to find on store shelves even before Dec. 31, 2011."

Although a notice about the phase-out date is prominently displayed on the product's label, Robert Rich Jr., M.D., of Bladenboro, N.C., a member of the AAFP Commission on Health of the Public and Science, said that he, too, is worried his patients with asthma might not be aware of the phase-out. And that lack of awareness could have some significant health consequences.

"The discontinuation of this OTC medication has the potential to cause an increase in untreated asthma exacerbations in the mild-to-moderate asthma sufferers who were not already being treated with prescription medications by their physicians," Rich told AAFP News Now. That's because patients with mild asthma now will need a prescription to buy any kind of inhaler.

"Posting notices in doctor's offices about the medication discontinuation and how to obtain a prescription for a prescription substitute" is likely the best way doctors can help patients become aware of the phase-out, said Rich.

The FDA has developed a number of resources to help in answering patients' questions about the discontinuation of epinephrine CFC inhalers, as well as to guide physicians and other health care professionals in choosing alternative medications for their patients with mild asthma.