FDA Officials Question Safety of Asthma Medicine

Federal Officials Convening a Committee of Experts on Drug Concerns

Dec 8, 2008 Christine Nyholm

The FDA is questioning the safety of diskus medications prescribed to control symptoms of asthma, including Advair, Symbicort, Serevent and Floradil.

The New York Times has reported that two federal drug officials have concluded that asthma sufferers risk death from the use of four popular asthma drugs, including Advair, Symbicort, Serevent and Foradil. Officials’ views are not universally shared within the government.

According the NY Times article, two officials who work in the safety division of the Food and Drug Administration wrote an assessment on the FDA website on December 5, stating that asthma sufferers of all ages should cease taking the medicine. A third official concluded that Advair and Symbicort could be taken by adults but that all four drugs should be ceased by people age 17 and under.

The federal agency is convening a committee of experts on Wednesday and Thursday to sort out the disagreement. The drugs will probably remain on the market, no matter what the committee decides, because federal drug safety officials have concluded that they are useful in patients who suffer from chronic obstructive pulmonary disease.

Asthma Definition

Asthma is caused when airways in the lungs spasm, swell and restrict the lung's supply of oxygen. The bronchial walls tighten and airways produce extra mucus that blocks the airways, according to the Mayo Clinic website.

The two primary treatments are steroids to reduce the swelling and beta agonists, which treat spasm.

Most rescue inhalers usually contain albuterol, which is a relatively short acting medication that seems to make patient’s lungs more vulnerable to severe attacks.

Asthma Medicines in Question

The four drugs in question are inhaled into the lungs, where the fine particles relax the lungs and make breathing easier. Following is a brief description from the company websites.

• Advair Diskus by Glaxo Smith Kline - According to the Advair website, more than 20 million people in the United States have asthma and an estimated 24 million adults have COPD. Advalr is recommended to prevent asthma symptoms from occurring and to improve lung function for better breathing. Advair does not replace fast acting inhalers.
• Symbicort by Astra Zeneca LP - According the Symbicort website, their asthma controller medicine controls asthma by reducing inflammation in the lungs and by keeping airways open. Symbicort will not replace a rescue inhaler.
• Serevent Diskus by Glaxo Smith Kline isa long acting bronchodilator with microscopic particles that are inhaled into lungs, causing air passages to relax and keep the airways open.
• Foradil by Schering-Plough in the U.S. and by Novartis outside the U.S.

Patients who have any concerns about medications should consult their physician. This article is for informational purposes only and is not to be construed as medical advice.

The copyright of the article FDA Officials Question Safety of Asthma Medicine in Allergies is owned by Christine Nyholm. Permission to republish FDA Officials Question Safety of Asthma Medicine in print or online must be granted by the author in writing.

SereVert Inhaler