Other safety alerts
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| The United States: Long-Acting Beta agonists (LABAs) and Inhaled Corticosteroids (ICS): Drug Safety Communication - Boxed Warning about asthma-related death removed |
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The US Food and Drug Administration (FDA) announces that FDA's most prominent warning, the Boxed Warning, about asthma-related death has been removed from the drug labels of medicines that contain both an ICS and LABA.
A FDA review of four large clinical safety trials shows that treating asthma with LABAs in combination with ICS does not result in significantly more serious asthma-related side effects than treatment with ICS alone. A description of the four trials is now also included in the Warnings and Precautions section of the drug labels. 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.
In 2011, FDA required the drug companies manufacturing fixed-dose combination drugs containing an ICS and LABA (GlaxoSmithKline, Merck, Astra Zeneca) to conduct several large, 26-week, randomized, double-blind, active-controlled clinical safety trials to evaluate the risk of serious asthma-related events when LABAs were used in fixed-dose combination with an ICS compared to ICS alone in patients with asthma. FDA reviewed the results of four trials involving 41,297 patients. The results demonstrate that the use of ICS/LABA in fixed-dose combination does not result in a significant increase in the risk of serious asthma-related events compared to ICS alone. The results of subgroup analyses for gender, adolescents 12-18 years, and African Americans are consistent with the primary endpoint results.
The four trials also assessed efficacy of the ICS/LABA products. The primary efficacy endpoint was asthma exacerbation, defined as a deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days, or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The results showed that the ICS/LABA combination reduced asthma exacerbations compared to ICS alone, noting that the majority of these exacerbations were those that required at least 3 days of systemic corticosteroids. This efficacy information has been added to the Clinical Studies section of the ICS/LABA drug labels.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm590001.htm
In Hong Kong, there are 26 registered pharmaceutical products containing both an ICS and LABA, and all are prescription-only medicines. Related news was previously issued by FDA, and was posted on the Drug Office website on 16 Apr 2011. The Department of Health (DH) will remain vigilant on safety update of the product issued by other overseas drug regulatory authorities.
Ends/Thursday, Dec 21, 2017
Issued at HKT 16:00
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