Regulatory Focus™ > News Articles > FDA Pulls Boxed Warnings on Asthma Risks on Some Inhalers

FDA Pulls Boxed Warnings on Asthma Risks on Some Inhalers

Posted 21 December 2017 | By Michael Mezher 

FDA Pulls Boxed Warnings on Asthma Risks on Some Inhalers

The US Food and Drug Administration (FDA) on Wednesday said it approved new labeling for inhalers that combine long-acting beta agonists (LABAs) and inhaled corticosteroids (ICS) after reviewing safety data from four clinical trials that showed that the combination of those drugs do not result in a significant increase in asthma-related side effects or deaths.

FDA has approved a number of ICS/LABA inhalers, such as GlaxoSmithKline's Advair Diskus (fluticasone propionate and salmeterol), AstraZeneca's Symbicort (budesonide/formoterol fumarate dihydrate), and Merck's Dulera (mometasone furoate/formoterol fumarate dihydrate) to treat asthma and chronic obstructive pulmonary disease (COPD).

In 2010, FDA required drugmakers to add warnings to ICS/LABA inhalers after it found an increased risk of serious adverse events, including deaths, in asthma patients treated with single-agent LABA inhalers.

The following year FDA ordered those companies to conduct five randomized postmarketing safety studies (four in adults and adolescent patients and one in pediatric patients) to determine whether ICB/LABA inhalers carried elevated risks compared to ICS-only inhalers.

Now after reviewing data from some 41,000 patients that participated in four of those studies, FDA says it has determined that ICS/LABA inhalers do not carry a significantly higher risk for serious adverse events.

"These trials showed that LABAs, when used with ICS, did not significantly increase the risk of asthma-related hospitalizations, the need to insert a breathing tube known as intubation, or asthma-related deaths, compared to ICS alone," FDA says.

However, FDA says it will still require the boxed warning for single-agent LABAs used to treat asthma without an ICS, and notes that ICS/LABA inhalers will still retain a warning about asthma-related risks posed by single-agent LABAs.


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