Advice for Patients: New Inhaler Propellants to Replace CFC Inhalers

All single-agent albuterol sulfate chlorofluorocarbon (CFC)-propelled metered dose inhalers will no longer be produced or sold in the U.S. after Dec. 31, 2008, according to a May 30 Food and Drug Administration (FDA) advisory.

This elimination of chlorofluorocarbon propellants is due to federal regulations on the use of ozonedepleting substances (including CFCs) in medicinal products and international agreements related to the larger phase-out of all commercially produced ozone-depleting substances. The CFC propellant will be replaced with hydroflouroalkane (HFA). Unlike CFCs, HFA has not been shown to harm the ozone layer.

The market withdrawal of all CFC-propelled albuterol inhalers, used to treat asthma and related disorders, will leave just three FDA-approved albuterol sulfate HFA-propelled oral inhalers available in the U.S.: PROAIR HFA, PROVENTIL HFA, and VENTOLIN HFA inhalation aerosol.

Driving up the cost of inhalers

Albuterol metered-dose inhalers are one of the most commonly prescribed medications in the U.S. with about 52 million prescriptions filled each year.

The Department of Health and Human Services and the FDA chose the Dec. 31, 2008, switchover date to ensure that adequate supplies of the HFA-propelled inhalers would be available and to allow a period of overlap for patients to transition from one product to the next. All three HFA products have been shown to provide a safe and effective alternative to the CFC-propelled versions.

Unlike the CFC-propelled albuterol inhalers, which are available in both brand and generic versions, all three of the HFA propelled products are brand name, and therefore higher-cost, products, their price being more than twice that of the older generic CFC versions. Because of this, some physicians have called for a delay in the final elimination of the CFC-propelled versions until 2010, when the first patents for HFA albuterol expire, or other intervention by Federal and private insurance systems to reduce the costs of HFA-propelled albuterol.

In a cost-benefit analysis, the U.S. Government Accountability Office estimated that the reduction in CFC emissions related to the change in albuterol inhalers is expected to be about 1,200 metric tons annually, but that additional costs associated with use of the brand-name HFA inhalers could reach $1.7 to $2.1 billion between December 2008 and late 2010, when generic HFA inhalers may first become available.

*Discount of 6% to 8% offered for purchase of prescriptions for multiple inhalers.
† Discount of 15% available for purchase of prescriptions for multiple inhalers.
‡Discount of 11% available for purchase of prescriptions for multiple inhalers.

Taste and feel the difference

The Center for Drug Evaluation and Research (CDER) ombudsman’s office received several complaints in 2007 that HFA propelled inhalers do not deliver the drug dose forcefully enough and clog easily, according to the FDA’s Center for Drug Evaluation and Research Ombudsman’s Annual Report for 2007.

In fact, the ombudsman’s office noted that concern about HFA propelled inhalers was among the top 16 most common contact topics from consumers and health care professionals in 2007.

The FDA acknowledges that patients may experience differences with the HFA-propelled albuterol inhalers compared to the CFCpropelled inhalers:

HFA-propelled albuterol inhalers may taste and feel different than the CFCpropelled albuterol inhalers. The spray of an HFA-propelled albuterol inhaler may feel softer than that of a CFC-propelled albuterol inhaler.

Although each of the three HFApropelled inhalers delivers 90 mcg (micrograms) of albuterol with each spray, there are differences in the three formulations of the albuterol sulfate HFA-propellant suspension contained in the different canisters.

To read the FDA’s update on the elimination of albuterol CFC inhalers and other ozone-depleting drug products, visit www.fda.gov/cder/mdi/albuterol.htm.

Summary

Because of environmental concerns, CFC-containing products such as asthma inhalers are being phased out. It is unfortunate that this was not done in a way that prevented the significant increased cost of the new formulation between the end of this year and when generic versions become available. We emphasize the importance of and urge that you become aware of the handling and use precautions for these new products as delineated in the box below.