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FDA Warns Of Asthma Drug Risks

Posted by Chrissie Cole
Monday, December 08, 2008 2:45 PM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, Asthma, COPD, Advair, Symbicort, Serevent, Foradil, LABA, Albuterol, GlaxoSmithKline, AstraZenca

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IMAGE SOURCE: © Wikimedia Commons / Asthma Inhaler / author: Mendel

The continued use of four popular asthma drugs - Advair, Foradil, SereVent and Symbicort– increases risk of asthma-related deaths and asthma attacks, according to two federal drug officials.

In an assessment, the officials, who work in the drug-safety division of the Food and Drug Administration (FDA), concluded that asthmatics of all ages should stop taking these medications.

A third drug-safety official advises Advair and Symbicort are safe for use in adults, but should no longer be used by patients under 17 years of age.

Conversely, Dr. Badrul A. Chowdhury, director of the FDA division that reviews pulmonary and allergy drugs, in his own assessment, warned that the risk of death linked with these drugs was minimal and banning their use “would be an extreme measure that could be problematic.”

The drugs, known as long-acting beta agonists (LABAs), currently carry the FDA’s strongest label warnings. The medication relaxes tight muscles around constricted airways, freeing asthma sufferers from the need to use their inhaler every few hours.

This week the agency will convene a committee of experts to help reach an agreement, which has divided not only the FDA, but physicians and experts for more than a decade. While the FDA has the final say it usually follows panel recommendations.

Nearly 17 million Americans have asthma. About five million of them are children. Many children outgrow asthma in their teen years. Each year, 5000 people die from asthma.

The FDA's latest analysis found 2.8 more serious asthma events for every 1,000 asthma patients treated with a LABAs. Children ages 4 to 11 "appeared to be at the greatest risk," FDA statisticians said.

Dr. Katharine Knobil, global clinical vice president for GlaxoSmithKline, dismissed conclusions by the agency’s drug-safety division as “not supported by their own data.” Both Advair and SereVent are safe when used along with a steroid, said Dr. Knobil.

A spokeswoman for AstraZeneca, said the agency’s drug-safety division omitted several studies of Symbicort in its analysis and that a review of all information shows the drug does not raise the risk of asthma-related hospitalizations and/or death.

In 1994 the Food & Drug Administration approved salmeterol xinafoate, sold as SereVent by GlaxoSmithKline and the agency began receiving reports of death linked to use. The company later issued a warning to patients that SereVent, unlike albuterol, does not work instantly and should not be used during an asthmatic attack.

In 1996, Glaxo launched a study of SereVent’s safety, but for years the company refused to publicly report findings. In 2001, Advair was introduced and its sales quickly surpassed that of SereVent.

The findings of the SereVent study were finally released in 2003, which found patients given the medicine, were more likely to die than those who were given placebo inhalers. According to the company, problems with the trial made interpreting its results impossible.

Asthma is a narrowing of the airways in the lungs brought on by hypersensitivity to certain stimuli. When these stimuli enter the lungs they cause the muscles in the airway to spasm, interfering with the airway. #


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