Source: AIDS  |  Posted 9 years ago

RESEARCH TRIANGLE PARK, NC -- February 20, 2002 -- Ventolin? HFA (albuterol sulfate HFA inhalation aerosol), a new environmentally friendly version of the asthma medication Ventolin? (albuterol, USP) Inhalation Aerosol, is now available in the United States.

The new product uses hydrofluoroalkane (HFA), instead of chlorofluorocarbon (CFC), to propel the medication out of the canister and into the lungs. Ventolin HFA is a short-acting bronchodilator that relieves sudden symptoms associated with bronchoconstriction -- tightening of the muscles surrounding the airways that occurs during asthma attacks. It is indicated for the treatment or prevention of bronchospasm in adults and children four years of age and older who have reversible airway disease, and for the prevention of exercise-induced bronchospasm in patients four years of age and older.

Ventolin HFA contains albuterol, the same active ingredient in Ventolin, a medication developed by a division of GlaxoSmithKline more than 30 years ago and now used by people with asthma worldwide. "Though there have been numerous advances in asthma treatment over the years, albuterol remains an important element of asthma management for the 17 million Americans who have the disease," said Doug Cline, MD, a primary care physician at Broadway Family Practice in Camden, New Jersey. "The introduction of Ventolin HFA means that people with asthma can now use an ozone-friendly version of a commonly used product to manage acute asthma symptoms."

In 1987, environmental concerns led to an international agreement called the Montreal Protocol that provided for the phase out of CFC production. CFCs have been banned in developed countries since 1996 for all but a few essential uses, including inhaled treatments for asthma.

GlaxoSmithKline is committed to phasing out the use of CFCs while continuing to ensure that patients have access to respiratory medicines. Ventolin HFA is the first HFA product to be introduced by GlaxoSmithKline in the United States.

Albuterol is widely used, with more than 48 million albuterol prescriptions dispensed in the U.S. in 2001, up from 43.6 million in 1996.(1) Though albuterol is a critical part of any asthma management plan, frequent use (more than twice a week) may be an indicator that asthma is not being adequately controlled.(2) There are two main causes of asthma symptoms: inflammation (swelling and irritation in the airways) and bronchoconstriction (tightening of the muscles surrounding the airways). Albuterol provides rapid relief from symptoms of bronchoconstriction by quickly relaxing airway muscles, but it does not treat the underlying inflammation or provide long-term control of asthma. According to current treatment guidelines,(2) patients who use albuterol more than twice a week may be candidates for long-term controller medications that reduce inflammation and/or help prevent bronchoconstriction, which reduces symptoms and the need for quick-relief medications.

"Albuterol should be used when needed, but not as a substitute for proper management of persistent asthma," said Dr. Cline. "Patients who rely on albuterol more than two times per week to help relieve their symptoms should talk with their doctor about long-term control."

In clinical trials of adults and children with asthma, Ventolin HFA demonstrated comparable safety and efficacy to the CFC Ventolin product.(3,4) The most common side effects were throat irritation, viral respiratory infection, upper respiratory inflammation, cough and musculoskeletal pain. The side effect profile in children was generally similar to that of adults. If a patient's symptoms become significantly worse when they use Ventolin HFA, they should call a doctor immediately, as this reaction can be life- threatening. This worsening of symptoms frequently occurs with the first use of a new canister.

Patients should tell their doctor if they have a heart, blood or seizure disorder, high blood pressure, diabetes or an overactive thyroid. Some medicines can interfere with how well asthma medications work. Patients should tell their doctor about all medicines they are taking, especially heart medicines and drugs that treat depression.

References
1. Total U.S. retail prescriptions dispensed for albuterol and albuterol sulfate in 1996 and 2001. Source? Prescription Audit (SPA); Scott-Levin, Inc.; 1996, 2001.
2. Practical Guide for the Diagnosis and Management of Asthma, National Heart, Lung, and Blood Institute, National Institutes of Health. NIH Publication No. 97-4053, October 1997.
3. Lumry W, et al. Switching from Ventolin (CFC) to Ventolin HFA is well tolerated and effective in patients with asthma. Ann Allergy. 2001 March; 86: 297.
4. Shapiro G, et al. Clinical Comparability of Ventolin Formulated with Hydrofluoroalkane or Conventional Chlorofluorocarbon Propellants in Children with Asthma. Arch Pediatr Adolesc Med. 2000 Dec.; 154: 1219-1225.

SOURCE: GlaxoSmithKline