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FDA Panel Backs Tougher Warning on Asthma Drugs for Kids
Date:11/28/2007

Serevent and Advair need specific child warnings on side effects, pediatric panel says; action follows panel's recommendation to toughen label on flu drugs for kids.

TUESDAY, Nov. 27 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel on Wednesday urged that stronger label warnings focused on children be added to the packaging for Serevent and Advair, two widely used asthma drugs.

Both drugs are long-acting beta agonist medications containing salmeterol, and are used as asthma prevention in children and adults age 4 and up.

But last year -- after a 2005 panel investigation focused mainly on the drugs' use by adults -- the FDA added a strong "black box" warning on both medications that they "may increase the risk of asthma-related death."

The panel's new recommendation is that this warning be extended specifically to pediatric users of the two drugs, according to Marketwatch, and that it include mention of the fact that the drugs could boost the risk of asthma-linked hospitalizations.

Both drugs are made by GlaxoSmithKline, which said it believed the current black-box warning was sufficient, according to Marketwatch. The FDA says it also plans a new safety review of the two drugs.

The announcement came after the same panel, the FDA's Pediatric Advisory Committee, recommended on Tuesday that the prescription flu drug Tamiflu (oseltamivir) should have a stronger warning label to reflect reports of bizarre behaviors and deaths among children who use the medication.

On Wednesday, the drug's manufacturer, Roche, accepted the recommendation, the Associated Press reported.

The panel, in a 9-5 vote, said Roche should change the drug's prescribing information because it doesn't adequately explain side effects reported by hundreds of patients in Japan and the United States, according to Bloomberg News.

The drug's label menti
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