FDA Panel To Decide On The Safety Of Asthma Drugs

By Alice Carver
07:00, December 12th 2008
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FDA Panel To Decide On The Safety Of  Asthma Drugs

A Food and Drug Administration panel of medical experts is weighing whether to allow certain asthma drugs to be marketed for the treatment of asthma amid concerns of side effects. One federal drug official strongly recommended that the commonly prescribed asthma drugs Serevent, Symbicort, and Foradil no longer be used to treat asthma in adults or children because they have serious side effects and they may increase the risk of asthma-related deaths.

Clinical trials have shown that patients taking Serevent, Symbicort, or Foradil have a small increased risk of asthma-related hospitalization. Serevent is a combination of an inhaled corticosteroid and the long-acting beta agonist (LABA) Serevent. Serevent and Advair are both used to prevent exacerbation of asthma by relaxing the airways. The medications already carry strong government warnings. The labels of Serevent and Foradil mention that doctors should prescribe them along with steroids. The problem is that only a half of patients who take the medicines also get a prescription for steroids.

In their two-day joint meeting, which is scheduled for Dec.10-11, the panel will review the findings from 110 clinical trials involving 61,000 patients, which compares patients who took an asthma-medication that contained a long-acting medication called LABA (for “long-acting beta 2-adrenergic agonist”) with those who only used a steroid as treatment for their asthma. The analysis, which looked for deaths, hospitalizations and cases in which patients had to have a breathing tube inserted, has found 20 deaths from asthma complications. Of these, 16 were in patients taking LABA-only drug, Serevent.

The medications were approved for children in 2006 in the U.S. Two years ago the agency advised consumers to limit the use of the drugs to patients who do not benefit from other similar medication following a study which showed chances of asthma-related deaths among Serevent users increased with 400 percent.

The FDA’s drug-safety officials recommended that the drugs no longer be given to children 17 and under who suffer from asthma, but split on whether the drugs should be banned for adults.

On the other hand, the companies that manufacture the drugs insist that they are not dangerous, and that there isn’t enough evidence to justify the prohibition of the drugs.

Asthma is a chronic respiratory disease which causes inflammation and narrowing of airways in the lung. The airways occasionally constrict, become inflamed, and are lined with excessive amounts of mucus, often as a response to one or more triggers, such as exposure to an environmental stimulant (e.g. an allergen, environmental tobacco smoke, cold or warm air, perfume, pet dander, moist air) or even emotional stress. Medication can help control the disease and relieve pressure in the airways during an asthmatic episode.

According to the National Institutes of Health, almost one in ten Americans is diagnosed with asthma at some time. The number of children with asthma has more than doubled since the 1980s. According to the CDC estimates, about 20 million Americans have asthma, including 9 million children.



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