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FDA Officials Differ Over Asthma Drugs' Risks

Armen Hareyan's picture

Two members of the U.S. Food and Drug Administration said Friday that people with asthma risk serious respiratory problems -- and even death -- if they continue to use four popular asthma drugs -- Advair, Symbicort, Serevent and Foradil, The New York Times reported.

But not all members of the FDA share that view. The agency has called a special two-day meeting of outside advisers for next Wednesday and Thursday to discuss data on the drugs and make recommendations on their use.

The two officials, who work in the FDA's safety division, posted an assessment on the agency Web site on Friday, saying asthma sufferers of all ages should not take the medicines. But a third FDA official concluded that Advair and Symbicort are safe for adults, but that all four drugs should no longer be used by children 17 and younger, the Times said.

Dr. Badrul A. Chowdhury, head of the FDA's division of pulmonary and allergy products, said his assessment found that the risk of death connected with the drugs was small, and that banning their use "would be an extreme approach" that could lead asthmatics to rely on other risky medications, the newspaper said.

The Associated Press said the drugs, known as long-acting beta agonists (LABAs), already carry the FDA's strongest warnings on their labels. The medicines relax tight muscles around constricted airways, freeing asthma suffers from the need to take a puff from their inhaler every few hours. For many people with asthma, that means they can sleep through the night.

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But for reasons still unclear, LABAs can increase the risk of death and respiratory complications in some patients. Those risks might be reduced if an LABA is used in tandem with a steroid to treat underlying inflammation in the airways. Current medical guidelines suggest using both kinds of drugs together for patients with chronic asthma who aren't responding well to other treatments, the AP said.

Dr. Katharine Knobil, global clinical vice president for GlaxoSmithKline, which markets both Advair and Serevent, told the Times that the FDA's drug-safety division findings weren't "supported by their own data." She said Advair was safe and Serevent was safe when used with a steroid.

Michele Meeker, a spokeswoman for AstraZeneca, which makes Symbicort, said the FDA's safety division improperly excluded most studies of Symbicort in its analysis. A review of all the data shows the drug doesn't increase the risks of death or hospitalization, she said, according to the Times.

Dr. Daniel Frattarelli, a Detroit pediatrician and member of the American Academy of Pediatrics's committee on drugs, said he treats children with Advair, and his committee had recently discussed the safety of the medicines.

"Most of us felt these were pretty good drugs. I'm really looking forward to hearing what the FDA committee decides," he told the newspaper.

Asthma is a chronic disease that can cause the airways to constrict, reducing airflow to the lungs. This can lead to wheezing, coughing, chest tightness and trouble breathing. Severe asthma attacks can be fatal, according to the U.S. National Library of Medicine.