FDA Urges Early Switch to HFA-Propelled Albuterol Inhalers

June 5, 2008
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration advised patients, caregivers, and healthcare professionals to switch to hydrofluoroalkane-propelled albuterol inhalers now because chlorofluorocarbon-propelled inhalers will not be available in the US after Dec. 31, 2008.

Rockville, MD (May 30)-The US Food and Drug Administration advised patients, caregivers, and healthcare professionals to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers now because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the US after Dec. 31, 2008. CFC-propelled albuterol inhalers are being phased out because they harm the environment by depleting the ozone layer.

FDA has approved three HFA-propelled albuterol inhalers: “Proair” HFA inhalation aerosol from Ivax (Miami, FL), “Proventil” HFA inhalation aerosol from Schering-Plough (Kenilworth, NJ), and “Ventolin” HFA inhalation aerosol from GlaxoSmithKline (London). The agency also approved Sepracor’s (Marlborough, MA) “Xopenex,” an HFA-propelled inhaler containing levalbuterol, a medicine similar to albuterol.

In an agency press release, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said, “FDA wants to emphasize that HFA-propelled albuterol inhalers are safe and effective replacements for CFC-propelled albuterol inhalers.”

Manufacturers have been increasing production of HFA albuterol inhalers, and FDA says an adequate supply is available now.

In the press release, FDA describes several differences between HFA- and CFC-propelled inhalers. For example, HFA-propelled albuterol inhalers may taste different than the CFC-propelled albuterol inhalers. The spray of an HFA-propelled albuterol inhaler may feel softer than that of a CFC-propelled albuterol inhaler, but the deep breath a patient takes is what brings medication into the lungs, according to the agency.

In addition, patients must prime and clean HFA-propelled albuterol inhalers to prevent drug buildup in the inhalation device. Drug buildup can block the medicine from reaching the lungs. Each HFA-propelled albuterol inhaler has different priming, cleaning, and drying instructions, and FDA recommends that patients read the instructions before using the inhaler.

A question-and-answer page posted on the agency’s website notes that HFA inhalers cost more than CFC inhalers. The page suggests that patients can ask drug companies or the Centers for Medicare and Medicaid Services for help paying for HFA inhalers.

The phase-out of CFC-propelled inhalers results from the Clean Air Act and the Montreal Protocol on Substances that Deplete the Ozone Layer, an international environmental treaty.

Albuterol inhalers are used to treat wheezing in patients with asthma and chronic obstructive pulmonary disease, which includes chronic bronchitis and emphysema. Patients use albuterol inhalers to deliver medicine directly into the lungs.