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FDA warns Aegerion's Beer on Fast Money Juxtapid comments
The FDA sends a warning letter to Aegerion Pharmaceuticals (AEGR +1.3%) in connection with comments CEO Marc Beer made on CNBC's Fast Money on June 5 and on October 31.Specifically, the FDA says Beer's comments "misleadingly suggest that Juxtapid is safe and effective for use in decreasing the occurrence of cardiovascular events [and] increasing the lifespan of patients with HoFH, and thus will have an effect on cardiovascular morbidity and mortality as well as overall mortality. However, Juxtapid is approved only for use as an adjunct to a low-fat diet and other lipid lowering treatments."Furthermore, the regulator reminds AEGR that Juxtapid's PI "specifically includes a limitation of use stating that the effect of the drug on cardiovascular morbidity and mortality has not been determined."The FDA also notes that Juxtapid as a monotherapy is "an unapproved use."