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FDA Panel Hearing Regarding Asthma Drugs

FDA staffers who police drugs after approval spoke before an advisory panel this week. What did the FDA panel hear? That none of the medicines known as long-acting beta-agonists (LABAs) should be given to children with asthma.

It was also argued that two Serevent and Foradil, should not be used by asthma patients of any age.

"We now know with high certainty that LABAs increase asthma mortality. Do the health benefits justify that?" asked FDA drug safety reviewer David Graham, who has been outspoken on medication risks and criticized the FDA's ability to manage them.

Graham said the answer clearly was no, as he saw little improvement among asthma patients treated with LABAs, particularly children. He estimated that as many as 14,000 deaths could be attributed to LABAs since 1994.

For more, go here.

Full post as published by A Georgia Lawyer on December 11, 2008 (boomark / email).