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Asthma Drug Dangers

Representing the Injured in Nevada

Do not discontinue taking any medications without first consulting your physician.

Asthma Medication Dangers!

Update II:
New labels have been required on asthma drugs Advair and Serevent to warn patients that the drugs “may increase the risk of asthma-related death.” GlaxoSmithKline, which makes both Advair®and Serevent®, agreed to the new ’black box’ warnings—the strongest warning a drug label can carry.

Update I:
On November 18, 2005, the Food and Drug Administration (FDA) requested manufacturers of Advair Diskus®, Foradil® Aerolizer®, and the Serevent® Diskus® to update their existing product labels with a new warning and medication guide that cautions of the medications possibly increasing the chance of severe asthma episodes, and death when the episodes occur (1).

Advair is the fourth best-selling drug in the world.  In 2005 it raked in $5.6 billion and accounted for 21.1 million prescriptions.

In April 2006, an article inForbesmagazine suggested that Advair may be killing some of the very patients it is supposed to help. A doctor interviewed in the article suggested that as many as 4,000 people a year are killed by Advair use (2).

On April 6, 2006, Dennis Kneale, Managing Editor ofForbes, appeared on theToday Showand said, “It might be that an additional 1 in 700 deaths happens because of Serevent […] the automobile accident death rate in the United States is 1 in 7,000.  So 1 in 700 would be 10 times the accident death rate.”

FDA Issues Asthma Medication Warning
On August 14, 2003, the FDA issued a warning stating that some patients taking a popular asthma medicine, salmeterol, a long-acting bronchodilator used to treat asthma and chronic obstructive pulmonary disease (COPD), are at increased risk of severe and possibly life-threatening asthma attacks.

What drugs contain Salmeterol?
Drugs affected by this warning include:

Serevent® Inhalation Aerosol (salmeterol xinafoate)
Serevent® Diskus® (salmeterol xinafoate inhalation powder)
Advair Diskus® (fluticasone propionate and salmeterol inhalation powder)

Serevent Diskus is approved for treatment of asthma patients aged 4 and older. Both Serevent Inhalation Aerosol and Advair Diskus are approved for patients aged 12 and older.

All three drugs are in the long-term control category of asthma medications. Long-term control medicines are taken every day, usually over long periods of time, to control chronic symptoms and to prevent asthma episodes or attacks. People with persistent asthma need long-term control medicines.

What is asthma?
Asthma is a chronic lung disease that currently affects more than 15 million Americans, approximately 40% of whom have moderate, persistent asthma. The FDA notes the number of asthmatics has increased significantly in recent decades and is currently estimated to cost the U.S. economy $12.3 billion a year in health care costs and lost productivity (NIH). Asthma is due to an inflammatory process in the bronchial air passages of the lungs that causes narrowing of the airways and, if untreated, may result in gradual loss of lung function.

A worsening of asthma symptoms is called an asthma episode or attack. Asthma attacks are not all the same; some are worse than others. In a severe asthma attack, the airways can close so much that not enough oxygen gets to vital organs; this condition is a medical emergency. People can die from severe asthma attacks.

What is being done to protect consumers?
In July 1996 GlaxoSmithKline (GSK), the maker of all three salmeterol-containing asthma drugs, initiated the Salmeterol Multi-Center Asthma Research Trial (SMART) study to investigate the safety of Serevent, particularly whether the drug might cause serious asthma-related adverse events. The SMART study revealed a higher number of asthma-related deaths and serious asthma episodes in patients treated in the Serevent group compared to placebo.

Analysis further showed a significantly greater number of adverse events, including death, in African-American patients taking salmeterol compared to those taking placebo. Additional analysis showed patients not taking inhaled corticosteroids at the beginning of the study appeared to be at greater risk for serious outcomes than those who had previously taken inhaled corticosteroids.

On January 23, 2003 the FDA announced an interim analysis of the SMART study suggesting that salmeterol may be associated with an increased risk of life-threatening asthma episodes or asthma-related deaths. At the same time, GSK notified the FDA it was halting the study. Later that year, the FDA required the three GSK asthma products that contain salmeterol to change the labeling to include new safety information and warnings . The new labeling contains a boxed warning about the increased risk of life-threatening asthma attacks or asthma-related deaths seen in patients taking salmeterol.

What should I do?
The FDA strongly advises patients that they should NOT stop taking these products without first talking to their physicians. If you are concerned about the potentially-dangerous effects of salmeterol, consult your physician to discuss your asthma treatment options. If you or someone you care about has used any of these medications and had serious problems, such as brain damage from oxygen deprivation or death, contact our lawyers today for an immediate and confidential evaluation of your case.

Do not discontinue taking any medications without first consulting your physician. This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician.

1) FDA Public Health Advisory -Serevent Diskus (salmeterol xinafoate inhalation powder), Advair Diskus (fluticasone propionate & salmeterol inhalation powder), and Foradil Aerolizer (formoterol fumarate inhalation powder) issued on 11/18/05, accessed on 11/21/05.

2) Trouble Breathing by Robert Langreth on 04/06/06. Accessed on 04/10/06 from www.Forbes.com.

This law firm is not affiliated with, sponsored by, or associated with GlaxoSmithKline, the FDA or Forbes.

Do not discontinue taking any medications without first consulting your physician. This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician.

Serevent®, Serevent® Diskus®, and Advair Diskus® are registered trademarks of GlaxoSmithKline and are used here only for the purpose of identifying the product in question.

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