April 15th, 2011
FDA Offers Cautious Support for Olmesartan (Benicar)
The FDA announced on Thursday that it had reviewed the results of the ROADMAP and ORIENT trials and had determined that the benefits of olmesartan (Benicar, Daiichi Sankyo) “continue to outweigh its potential risks” when used as indicated for the treatment of high blood pressure. In June 2010 the FDA had announced that it was conducting a safety review of the drug based on the unexpected finding of a greater number of deaths from cardiovascular causes associated with olmesartan in the two trials.
The FDA also said that it was working with Daiichi Sankyo to perform additional studies and conduct additional analyses of completed studies “to obtain more complete information about the cardiovascular risks or benefits” of the drug.