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FDA Issues Warning on Key Asthma Drugs
Date:2/18/2010

sthma symptoms by relaxing the lung's airway muscles.

The makers of the four drugs will have to add this information to their product labels:

  • These drugs must be used along with other asthma medications such as an inhaled corticosteroid.
  • The drugs should only be used in patients whose asthma is not controlled by other drugs.
  • They should be used for the shortest time possible to bring asthma under control, then other asthma drugs should replace them.
  • Children and adolescents who need these drugs should use only combination drugs that contain both a LABA and a corticosteroid.

Although the drugs are also approved for use in chronic obstructive pulmonary disease (COPD), this warning only applies to their use by asthma patients, the agency said.

In addition, the FDA is requiring that manufacturers of these drugs do more studies to determine the safety of these medications when combined with inhaled corticosteroids.

The announcement follows on an FDA advisory panel decision in December 2008. The panel found that the risks linked to single-agent Serevent and Foradil outweighed their benefits for children and adults. At the time, Advair and Symbicort were excluded from that decision.

More information

For more information on asthma, visit the U.S. National Institutes of Health.



SOURCES: Feb. 18, 2010, teleconference with: John Jenkins, M.D., director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


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