FDA Calls For Class-Wide REMS For LABA Asthma Drugs
On top of a class-wide Risk Evaluation and Mitigation Strategy for the long acting beta-2 adrenergic agonist class of asthma drugs, FDA is going to work through its Safe Use partners to monitor whether actual use adjusts based on the new safety measures
You may also be interested in...
US FDA concludes that combination products do not increase risk of serious asthma-related events compared to inhaled corticosteroids alone.
LABA prescribing patterns haven’t changed despite FDA’s labeling instructions on asthma safety concerns, agency concludes.
LABA safety issues may come to haunt GlaxoSmithKline as FDA’s Pulmonary-Allergy Drugs and Drug Safety and Risk Management advisory committees will focus on the combination’s product’s safety database and whether an outcomes study is needed for approval in asthma.