WASHINGTON (Reuters) - U.S. health officials on Thursday called for new warnings on certain asthma drugs to help reduce overall use of these medications, saying the medicines should not be used unless taken in combination with other inhaled drugs.
The Food and Drug Administration said its review of the drugs -- long-acting beta-agonists (LABAs) that include GlaxoSmithKline PLC’s Symbicort -- found they can increase the risk that asthma symptoms will worsen, and lead to hospitalizations and death.
The restrictions also affect two lesser-used medicines, Glaxo’s Serevent and Novartis AG’s Foradil.
Manufacturers must include warnings on the products that state the drugs should not be used alone in adults and children and should be taken along with inhaled corticosteroids, the FDA said. The warnings to patients and doctors also say the drugs should only be used long-term in patients who cannot control their asthma with other medications and should be used for the shortest time possible.
The companies must also conduct additional studies about the use of LABAs in combination with inhaled corticosteroids, the agency said.
Reporting by Susan Heavey, editing by Matthew Lewis
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