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The safety of the drugs -- Serevent manufactured by GlaxoSmithKline P.L.C., Symbicort made by AstraZeneca, and Foradil from Novartis AG -- will be reviewed by outside medical advisers to the FDA at a two-day hearing next week in Rockville, Md.
While three of the medications, known as long-acting beta agonists, or LABAs, had a "positive risk difference" in clinical studies, it was only "statistically significant" for Serevent, FDA staff said, in briefing materials posted today on the agency's Web site.
A fourth drug, Advair made by GlaxoSmithKline, had no increased risk of respiratory complications, FDA staff said. Advair has about $4 billion in annual sales, and is Glaxo's biggest product.
Medical experts will consider the potential risks of all LABAs, including Advair, at the two-day hearing Wednesday and Thursday, hear presentations by the drugmakers, and make recommendations. The drugs already carry strong warnings, but the findings next week could lead to more specific instructions for patients.
Children, ages 4 to 11, taking LABA drugs appeared to be at greatest risk for complications than those taking older treatments, FDA staff said. African Americans showed elevated risk compared to other groups, and females had higher risks than males.
In clinical studies, there were 20 asthma-related deaths -- 16 in patients treated with LABA drugs, and four among patients taking other non-LABA medications. "All the asthma-related deaths were among Serevent-treated subjects," the FDA said.
Separately, the FDA is investigating a possible link between Singulair, Merck & Co's popular allergy and asthma drug, and suicide.
In March, the FDA said it was reviewing Singulair for potential safety issues after receiving a handful of reports of mood changes, suicidal behavior, and suicide in patients who had taken the drug.
The FDA review of Merck's biggest product, with $4.3 billion in annual sales, is likely to wrap up in the next month or two, said Timothy Anderson, analyst at Sanford C. Bernstein & Co., in a research note today.
"Investors need to be mindful of these ongoing safety reviews by FDA and their potential commercial implication," he wrote.
Merck updated Singulair's labeling four times in the last year to include information on a range of reported side effects: tremors, anxiousness, depression and suicidal behavior.
The FDA is notifying the public earlier about possible safety issues. The policy change came after the agency was criticized for acting too slowly on information about the risks of Merck's painkiller Vioxx and GlaxoSmithKline P.L.C.'s diabetes pill Avandia.
Contact staff writer Linda Loyd at 215-854-2831 or lloyd@phillynews.com.
To see more of The Philadelphia Inquirer, or to subscribe to the newspaper, go to <a href=http://www.philly.com>http://www.philly.com</a>. Copyright (c) 2008, The Philadelphia Inquirer Distributed by McClatchy-Tribune Information Services. For reprints, email tmsreprints@permissionsgroup.com, call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.
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