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.

4 Responses to “FDA Offers Cautious Support for Olmesartan (Benicar)”

  1. Isaac Vilayil Mammen, M.D., D.M. says:

    Isn’t it safer to use other ARBs or ACEI till the matter is cleared.

  2. Ultimately, it always comes down to the same thing for providers, weighing the pros and cons for each individual patient before initiating ANY new therapy. I have had patients who were intolerant of ACE inhibitors, uncontrolled on other ARBs and yet were able to reach goals for HTN control without any apparent problems on Olmesartan. I’m not saying I won’t consider the findings of these studies during the process of choosing a ‘new’ anti-HTN agent for a patient needing control or better control of BPs. This data just won’t be the first (or last) thing to consider in this decision process. I’m just glad the FDA hasn’t decided to remove another agent from the ‘toolbox’ available to providers, when we still have so far to go in achieving control of blood pressure for so many of our patients.

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  3. Still, the excess cardiovascular mortality in ROADMAP was a concern. I wonder how they will assess it now that there was a suggestion of a problem – how will we get assurance that it is as safe as the other ARBs? Do we need that?

  4. William DeMedio, MD says:

    If the FDA says use it cautiously, I will do so. There are a number of ARB’s available with no known CV risk issues. These you only need be concerned with the usual cautions about ARB’s eg hyperkalemia, allergies, interactions with other drugs. I will allow the audience to draw their own conclusions as to what to do and what caution means. Use all drugs cautiously is my motto.

    Competing interests pertaining specifically to this post, comment, or both: