Asthma Warnings Not Working Well, FDA Fears As GSK Seeks Expanded LABA Approval

LABA prescribing patterns haven’t changed despite FDA’s labeling instructions on asthma safety concerns, agency concludes.

An FDA analysis of epidemiologic and drug utilization data for a class of respiratory drugs highlights the limits of the agency’s risk management strategies when it comes to changing prescribing practices of potentially dangerous treatments.

These data on the use of long-acting beta agonists (LABAs) were also supported by the results of a Mini-Sentinel study that looked at the prescribing practices of the drug class...

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