May 30, 2008 -- The FDA is reminding patients that many albuterol metered-dose inhalers will soon be removed from the U.S. market.
Inhalers containing chlorofluorocarbon (CFC) propellant will become illegal to produce or sell in the U.S. after Dec. 31, 2008. The phaseout is part of a worldwide effort to eliminate CFCs because they deplete the atmosphere's ozone layer.
"No CFC-propelled inhalers will be available for sale after that date," says Deborah Henderson, senior advisor in the FDA's Office of Executive Programs.
At an estimated 52 million prescriptions per year, albuterol inhalers are among the most popular medications in the U.S. The majority of U.S. patients already use newer albuterol inhalers containing hydrofluoroalkane (HFA).
But CFC-containing inhalers still occupy about 35% of the market, says Badrul Chowdhury, MD, PhD, the director of the FDA's Division of Pulmonary and Allergy Products.
Four HFA-propelled albuterol inhalers are available in the U.S., including Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. In addition, an HFA-propelled inhaler containing levalbuterol, a medicine similar to albuterol, is sold under the brand-name Xopenex HFA Inhalation Aerosol.
The FDA issued a public health advisory alerting patients that newer HFA-propelled inhalers may feel and taste different from CFC-propelled medications.
HFA-propelled inhalers may also be dispensed in a smaller puff than patients are used to, Henderson says. "But patients should know that doesn't mean they're not working."
HFA-propelled inhalers are also more expensive than older CFC-containing products. While one generic company, Armstrong, still makes millions of CFC-containing inhaler packs each year, there is no generic form of HFA inhalers, Chowdhury says.
Insurance companies and drug companies are offering rebate programs and payment assistance for the more expensive inhalers, the FDA says. Patients can visit several web sites, including www.inhalertransition.org, for more information.