FDA issues warning on asthma medication

WASHINGTON -- Some patients using a popular asthma medication called salmeterol may actually face a small increased risk of severe, and occasionally fatal, asthma attacks, the Food and Drug Administration warned Thursday.

The side effects are rare, and FDA said the drug's benefits still appear to outweigh the potential risks when patients follow medication instructions. It is dangerous to abruptly stop taking the drug, so concerned patients should talk with a doctor, FDA cautioned.

The FDA first alerted patients and doctors to the problem in January, and now has formally added the warning to the labels of three salmeterol-containing brands -- Serevent Inhalation Aerosol, Serevent Diskus and Advair Diskus.

Salmeterol is a long-acting drug used to prevent asthma attacks by relaxing airways. Salmeterol users are urged to always have a fast-acting medicine -- an inhaled corticosteroid -- on hand in case the prevention fails and they have problems breathing.

GlaxoSmithKline, which makes all three salmeterol products, launched a large study to compare how well people using inhaled Serevent fared compared with those given a dummy drug. The study was supposed to enroll 60,000 subjects but was stopped early when researchers counted more asthma-related deaths among Serevent users -- particularly black patients. The study counted 13 asthma-related deaths among 13,174 Serevent users, compared with four deaths among 13,179 placebo recipients.

Among black participants, there were eight Serevent users who died vs. one placebo recipient.

The study couldn't tell whether the people who died had failed to keep asthma attack-battling corticosteroids on hand, FDA said.

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On the Net:

FDA: http:/www.fda.gov

GlaxoSmithKline: http://www.gsk.com