Drug Safety Oversight Board Meeting: December 1, 2005, Public Summary
Board Update: The Executive Director summarized patient information and healthcare practitioner sheets (described below as “sheets”) and Public Health Advisories ( PHAs) posted since the last meeting, and the Board discussed the actions. The following actions were presented:
Long-Acting Beta Agonists (LABA) (salmeterol xinafoate (marketed as Serevent Diskus), fluticasone propionate; salmeterol xinafoate (marketed as Advair Diskus), formoterol fumarate (marketed as Foradil). Sheets and a PHA were issued following a clinical trial associating LABA drugs with increased risk of worsening asthma symptoms in some patients. Members discussed the implications of the alerts for the use of LABA drugs for other indications such as COPD, and recommended that future sheets include statements relating new information to other uses (labeled and common unlabeled) of the product.
Mifeprex (mifepristone). Sheets were updated to reflect reports of infections with Clostridium sordellii in patients using the drug. Related articles published in the New England Journal of Medicine December 1, 2005, were noted.
Campath (alemtuzumab). Sheets were issued November 30, 2005. The sheets emphasize serious and, in one case, fatal occurrences of idiopathic thrombocytopenic purpura (ITP) in participants in a clinical trial that showed efficacy of Campath in Multiple Sclerosis (MS). The FDA technical expert explained that an objective of the sheets was to avoid possible increase in off-label use of Campath for MS, in view of a company press release announcing both efficacy and adverse events, but stressing the former.
The Board also discussed other emerging safety issues and strategies being considered to address them.