Switch to HFA-propelled albuterol inhalers now, FDA advisory urges.

In a public health advisory, the Food and Drug Administration is urging health care professionals and their patients and caregivers to switch to hydrofluoroalkane-propelled albuterol inhalers before chlorofluorocarbon-propelled inhalers are taken off the market Jan. 1, 2009.

Chlorofluorocarbon (CFC)-propelled albuterol inhalers will not be produced or sold in the United States in 2009 and beyond in order to meet mandates authorized by the Clean Air Act and an international environmental treaty, the Montreal Protocol on Substances That Deplete the Ozone Layer. CFCs are identified as contributors to the depletion of the ozone layer.

Three hydrofluoroalkane (HFA)propelled albuterol inhalers have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. An inhaler containing levalbuterol (similar to albuterol) is available as Xopenex HFA Inhalation Aerosol. HFA-propelled albuterol inhalers are not currently available in generic forms.

"Manufacturers of the HFA versions have created financial assistance programs and eased income restrictions for low-income patients. Physician, pharmacy, and manufacturer's Web sites are also offering coupons for those who face a higher copay for these products," said Deborah Henderson, senior adviser in the Office of Executive Programs at the FDA's Center for Drug Evaluation and Research.

The spray from HFA-propelled inhalers may taste and feel different than CFC-propelled inhalers. The properties of HFA and the weaker force of its spray from the inhalers make it "important to clean and prime the inhalers in order for the right dose of medicine to be delivered. Patients should be reinforced with the knowledge that they need to follow the directions very carefully," Ms. Henderson said in a press teleconference. The changes do not affect the medication's safety or effectiveness, she noted.

In the beginning of 2008, HFA-propelled albuterol inhalers composed only 5%-10% of albuterol inhaler sales in the market--even though the FDA in 2005 had finalized the end date for the sale of CFC-propelled albuterol inhalers.

HFA-propelled albuterol inhalers now account for about 65% of the market, according to Dr. Badrul Chowdhury, director of the Division of Pulmonary and Allergy Products at the FDA's Center for Drug Evaluation and Research. About 52 million albuterol metered-dose inhalers are prescribed in the United States each year, making them among the top 10 prescribed medications in the country, Dr. Chowdhury said during the teleconference.

Over the years, many manufacturers have stopped producing CFC-propelled albuterol inhalers. Currently, only one company, Armstrong Pharmaceuticals Inc., manufactures generic CFC-propelled albuterol inhalers, he said.

BY JEFF EVANS

Senior Writer

More information about the transition is available at www.inhalertransition.org, www.transitionnow.org, and www.pparx.org.