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Pharmaceuticals / Postmarket Safety / Commercial Operations

FDA Removes Boxed Warning from LABA/ICS Inhalers Following Postmarket Studies

Dec. 27, 2017

The FDA removed its Boxed Warning regarding asthma-related death from the labels of medicines containing long-acting beta agonists in combination with inhaled corticosteroids, following postmarket studies of possible side effects.

In 2011, the agency required inhaler manufacturers to conduct four large clinical trials to evaluate the safety of the combination compared to corticosteroids alone. The trials involved over 41,000 patients: three were conducted in patients 12 years and older, and one in children 4 to 11 years.

The trial results showed the combinations did not significantly increase the risk of asthma-related hospitalizations, intubations or asthma-related deaths. They also showed that ICS/LABA combination medicines were more effective in decreasing asthma attacks compared to ICS alone. This information has been added to the combination product labels, and was included in alerts to healthcare professionals in patients, the agency said.

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