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FDA Orders "Black Box" Warning for Asthma Drugs

July 14, 2005
The US Food and Drug Administration has cleared asthma drugs Advair and Serevent, allowing them to stay on the market as long as warning labels clearly alert patients to potential risks.

Made by GlaxoSmithKline, the medications contain salmeterol, a bronchodilator known as a beta2-agonist. It works by relaxing the bronchial muscles, thereby improving air flow for many of the 15 million asthma sufferers in the U.S.

Regulators became alarmed when Glaxo reported that it had to stop tests of the drug when about 50 out of 26,000 patients being studied suffered more severe asthma attacks. A few died.

After a review by its panel of experts, the FDA voted 12-0 to keep the drugs on the market while adding a "black box" warning, the most extreme warning that can be put on drugs.

The tests were launched in 1996 at the behest of the FDA to address specific questions about Serevent and Advair. In 2003, the trials were stopped after 50 people experienced serious, life-threatening episodes or died, compared with 36 episodes in patients who had been given a placebo.

One statistic that initially raised concerns was that African-Americans in the study appeared to have a higher rate of death. Twenty black people who had receive the drug died, compared with five who were taking the placebo.

But doctors involved in the study and other researchers agreed that the statistic was misleading and did not indicate that blacks were at higher risk of dying from taking the drugs. FDA panelists stressed that the higher death rate in the test was a fluke and that it would be irresponsible to mislead blacks into turning from medication that could prolong their lives.

Asthma is a dangerous disease, especially when it is untreated or under-treated. No one now taking prescribed medications should stop taking them without consulting their physician. It can be dangerous to suddenly stop taking prescribed medications.

Sales of Servent and Advair, marketed as Seretide in Europe, topped $4 billion last year. Novartis' asthma remedy, Foradil, which was also reviewed, brought in only $320 million.

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