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FDA Panel: Asthma Drugs Should Stay on Market

But advisers recommend new safety warning on labeling for one drug, Foradil

WEDNESDAY, July 13, 2005 (HealthDay News) -- A 13-member U.S. Food and Drug Administration advisory panel voted unanimously late Wednesday to recommend that three widely used asthma drugs -- Advair, Foradil and Serevent -- stay on the market.

However, the Pulmonary-Allergy Drugs Advisory Committee also advised that labeling for one of the three medications, Foradil, should carry safety warnings equivalent to those mandated for Advair and Serevent in 2003.

FDA officials rely on advisory panels in their decision-making process, and usually follow panel recommendations.

In a statement released before the meeting, the FDA said it was concerned about "severe asthma exacerbations in a small number of patients" using these drugs.

The committee focused its attentions on the three products, but only two long-acting, beta-agonist drugs were at issue: salmeterol xinafoate and formoterol fumarate, both of which are sold in the United States. The former is sold as a single-ingredient product under the brand name Serevent as well as in a combination product (with the corticosteroid fluticasone propionate) under the brand name Advair. The latter product is sold as a single-ingredient product under the trade name Foradil.

A post-marketing trial conducted by GlaxoSmithKline, makers of salmeterol, showed a statistically significant increase in asthma-related deaths (four times as many as with a placebo), respiratory-related deaths (about twice as many) and in combined asthma-related deaths or life-threatening experiences (almost twice as many). The exacerbations were particularly pronounced among blacks.

As a result, that trial was stopped early, and in 2003 the company incorporated the preliminary results into the labels of both Serevent and Advair.

Serevent was singled out by FDA whistleblower Dr. David Graham when he discussed the inability of the federal agency to protect the nation's drug supply during the hearings into the controversial painkiller Vioxx, which was found to cause increased risk of heart attack and stroke.

Similarly, trials on formoterol conducted by the drug's maker, Novartis Pharmaceuticals, found exacerbations in people taking the higher dose (24 micrograms). As a result, the only dose approved for marketing in the United States is 12 micrograms every 12 hours.

In their decision Wednesday, the FDA panel voted 12 to 1 in favor of labeling Foradil with "warnings similar to those in the salmeterol [labels]."

Although these drugs are indicated for use in patients with asthma as well as chronic obstructive pulmonary disease (COPD), the issues debated by the panel related only to their use against asthma.

Doctors have long relied on all three medications to treat asthmatic patients. "I continue to use these drugs because they're so effective and important," said Dr. Adam Wanner, a professor of medicine at the University of Miami School of Medicine.

The drugs work by relaxing the smooth muscle in the airways.

"Asthma is a relentless, chronic inflammatory disease. The inflammation results in the smooth muscle of the airways being hyperreactive, and they can constrict and narrow the airways," explained Dr. Michael Iannuzzi, chief of pulmonary, critical care and sleep medicine at Mount Sinai Medical Center in New York City. "That constriction of the airway results in the symptoms of cough, wheezing, chest tightness and shortness of breath. The beta agonists are bronchodilators that stimulate the smooth muscles of airway to resize."

An enormous number of people worldwide use these drugs.

Roughly 5 percent to 6 percent of the U.S. population suffers from asthma. "You figure that about 60 to 70 percent of those require regular medication and these are essentially the most commonly used medications," Wanner said. "That's a tremendous number of individuals."

According to The New York Times, Advair was the third best-selling drug in the world in 2004.

"These medications are a staple of treatment, and are part of recommendations by national and international groups as to how one treats patients with asthma and COPD," Wanner added.

In general, Iannuzzi said, the combination product Advair is less of a problem than the single-ingredient products. "When you use the long-acting beta agonists alone, you are running the risk of masking the underlying inflammation by just treating the symptoms and not getting at the cause of the problem," he said.

More information

For more on asthma medications, visit the American Academy of Allergy, Asthma and Immunology.

SOURCES: Adam Wanner, M.D., professor of medicine, University of Miami, Fla.; Michael Iannuzzi, M.D., chief of pulmonary, critical care and sleep medicine, Mount Sinai Medical Center, New York, N.Y.; Laura Alvey, U.S. Food and Drug Administration; July 13, 2005, New York Times; FDA briefing paper; July 13, 2005, FDA statement.
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