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April 18, 2011

FDA orders safety studies for some asthma drugs

Quoted from http://www.reuters.com/article/2011/04/15/us-fda-asthma-idUSTRE73E65A20110415

FDA orders safety studies for some asthma drugs

By Esha Dey and Bill Berkrot

WASHINGTON/NEW YORK | Fri Apr 15, 2011 3:30pm EDT

WASHINGTON/NEW YORK (Reuters) - U.S. health regulators have ordered drugmakers to conduct clinical trials involving a total of 53,000 patients to test the safety of a controversial class of inhaled asthma drugs that are already on the market.

The trials are being required to demonstrate the safety of medicines known as long-acting beta-agonists (LABAs) when used in combination with inhaled steroids, another class of asthma drugs, the U.S. Food and Drug Administration said on Friday.

LABAs to be studied are AstraZeneca's Symbicort, GlaxoSmithKline's Advair Diskus, Merck & Co's Dulera, and Novartis AG's Foradil.

LABAs have long been under FDA scrutiny as they can increase the risk of severely worsening asthma symptoms that can lead to hospitalizations and death.

[Article continues at original source]

Posted at 12:25 PM in Advair, Dulera, Foradil, Symbicort |

Tags: Advair Diskus, asthma medications, AstraZeneca, drug safety, Dulera, FDA, Foradil, GlaxoSmithKline, LABAs, long-acting beta-agonists, Merck & Co, Novartis AG, Symbicort

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