FDA Warns About Asthma Drugs Advair®, Foradil®, and Serevent®
WASHINGTON, DC — November 23, 2005 — The asthma drugs Advair®, Foradil®, and Serevent® may actually increase a patient’s risk of severe asthma episodes and death, according to a Public Health Advisory issued by the Food and Drug Administration (FDA). The agency is asking the manufacturers of these medicines to add new warnings to the drug labels and to develop Medication Guides for patients.
The three asthma drugs are “long–acting beta 2–adrenergic agonists”, which are medicines that help relax the muscles around the airways in the lungs. Approved for twice–a–day use, the drugs may prevent some asthma episodes but should not be expected to stop asthma attacks that are already in progress. Advair®, Foradil®, and Serevent® should not be the first drugs used to treat asthma. Instead, doctors may prescribe the drugs only if other medicines such as corticosteroids do not control the asthma. (A corticosteroid is an anti–inflammatory medicine that relieves swelling in the airways.)
Although Advair®, Foradil®, and Serevent® decrease the frequency of asthma attacks, these medicines may make asthma episodes much more severe when they do occur, the FDA warns. In one study, patients took salmeterol, an active ingredient in both Advair® and Serevent®. Salmeterol users were more likely to need respirators or ventilators due to severe asthma attacks than did asthma patients who took fake pills or placebos. Four times as many salmeterol users died compared to those who did not take the drug.
In July of this year, an FDA advisory panel met to discuss health problems caused by Advair®, Foradil®, and Serevent®. It recommended a “black box” warning on the prescribing instructions for Foradil®. That is the most urgent alert short of withdrawing a drug from the market. Black box warnings about asthma–related deaths are already included in the Advair® and Serevent® prescribing instructions. The panel also noted that all three drugs increased the risk of severe asthma episodes. Nevertheless, the panel voted to keep the asthma drugs on the market.
Asthma in the United States
Over 20 million people in the United States have asthma, and about 12 million had an asthma attack in 2000 (Centers for Disease Control, Basic Facts About Asthma). Each year, asthma causes over 1.5 million emergency department visits, about 500,000 hospitalizations, and over 5,500 deaths (National Heart, Lung and Blood Institute).
Nationwide, health care costs for asthma total about $16.1 billion annually (American Academy of Allergy, Asthma and Immunology). The largest medical expense is prescription drugs, which comes to over $5 billion.
Injuries from Advair®, Foradil®, or Serevent®
Brayton Purcell is currently evaluating injuries from Advair®, Foradil® and Serevent®. Please feel free to contact us if you or a loved one has been seriously affected by any of these drugs. We will review your case free of charge and let you know your legal choices.