U.S. Army Captain Michael Kelvington, commander of the Battle company, 1-508 Parachute Infantry battalion, 4th Brigade Combat Team, 82nd Airborne Division, bows next to remains of Gulam Dostager, a member of Afghan Local Police who was killed in the blast of an Improvised Explosive Device (IED) during the joint Tor Janda (Black Flag in Pashtu) operation, in Zahri district of Kandahar province, southern Afghanistan May 25, 2012.  REUTERS/Shamil Zhumatov  (AFGHANISTAN - Tags: MILITARY CIVIL UNREST CONFLICT TPX IMAGES OF THE DAY)

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U.S. requires new warnings for asthma drugs

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WASHINGTON | Thu Feb 18, 2010 1:57pm EST

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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Comments (1)
logic wrote:
Dumb stupid intruding librul gubmint…how dare they make drug corporations tell people all the nasty things their drugs can do.

Feb 18, 2010 3:52pm EST  --  Report as abuse
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