What information did FDA review to help the Agency decide to require a risk management program?
A. FDA used a variety of studies and research in patients with asthma using a LABA. Two specific studies that provided valuable information were 1) the Salmeterol Multi-center Asthma Research Trial (SMART) and 2), the Serevent Nationwide Surveillance study (SNS). Salmeterol is the LABA in Serevent. Each of these studies showed a higher risk of death for patients with asthma that used a LABA (salmeterol) compared to patients with asthma that did not use a LABA. In addition, FDA used a research method called a meta-analysis to further understand the risks associated with the use of LABAs in patients with asthma. A meta-analysis uses data from multiple studies on a particular topic to enable scientists to combine information from those studies to make scientific conclusions or recommendations in that area. For more information on these specific studies, please see February 2010 LABA Drug Safety Communication for more information.
Related Questions
- This program is going to require more people to work in the classrooms – are there grants or anything to help pay for that?
- Does using the Integrated Risk Management Program (IRMP®)require me to change who supplies my actual product?
- Why did FDA decide that retailers must require customers under the age of 27 to present a photo ID?
