The US Food and Drug Administration have cleared asthma drugs Advair and Serevent, deeming them safe to stay on the market as long as warning labels are present to inform patients of the potential risks.
Combined with a corticosteroid, the drugs raised safety concerns after Glaxo had to stop tests on the drugs when a small number of patients (50 out of 26,000) suffered more severe asthma attacks and/or died during treatment.
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.
The FDA voted 12-0 to keep the drugs on the market with so-called black box warning labels, the most extreme of warnings that can be put on drugs and keep them legal.
In 1996, at the behest of the FDA, Glaxo began the “SMART trial” 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 people that had been given a placebo.
Another interesting statistic, which doctors involved in the study say is misleading, was that black people appeared to have a higher rate of death. Twenty black people died during the trial, compared to five that took the placebo.
Dr. Mark Brantly, an FDA panelists says that part of study could lead to some irresponsible misconceptions.
“It is critical that that message not go forward,” he said.
The FDA also looked at ways to make the findings of the study clearer. Calman Prussin of the National Institutes of Health suggested putting them in graph form rather than in text.
