Yesterday a panel of outside experts commissioned by the FDA advised the administration that the popular asthma medications Advair and Serevent should carry an additional warning for use in children. The new warning, if accepted by the FDA, will reportedly advise of a potential increased risk of asthma related hospitalization. The panel also said the warning should be more specific for children.
The panel also urged the FDA to move swiftly concerning safety reviews of the drugs to better understand the risks associated with them. They also expressed concerns over another drug, Foradil, in the same category, known as long-acting beta agonists. All three of these medications already carry strong warnings about cardiovascular risks and additional studies could reveal additional risks.
The FDA doesn’t have to follow the advice of outside panels like the one that met today, but it tends to do so. The director of the agency’s office of pediatric therapeutics said the FDA would consider adding new warning language to the drugs’ labels while it studies the safety the asthma drugs in children, according to the WSJ.
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