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# FDA Drug Safety Podcast: FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required
- URL: https://www.foodconsumer.org/olmesartan_0702141114/
- Published: 2014-07-02T12:13:00.000Z
- Updated: 2026-09-15T12:00:01.000Z
- Description: FDA finished its safety review and found no clear evidence that olmesartan raises cardiovascular risk in diabetic patients, so its use recommendations stay the same, though study information must be added to the labels. Patients should not stop blood pressure medicine without asking their doctor.
- Author: Food Consumer
- Tags: Miscellaneous, Health News, #vivvo-import

#   

[](http://www.fda.gov/downloads/Drugs/DrugSafety/DrugSafetyPodcasts/UCM403005.mp3?ref=foodconsumer.org)

Welcome to the FDA Drug Safety Podcast for healthcare professionals from the Division of Drug Information. Today’s topic: FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required

On June 24, 2014, FDA issued a Drug Safety Communication announcing that it has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with the use of the blood pressure medication olmesartan in diabetic patients. As a result, our recommendations for use of olmesartan (Benicar, Benicar HCT, Azor, Tribenzor, and generics) will remain the same, but we will require information about some of the studies to be included in the drug labels. Patients should discuss any questions they have with their health care professionals.

It is important to take olmesartan and other blood pressure medicines because uncontrolled high blood pressure increases the risks of cardiovascular problems such as heart disease and stroke, as well as kidney failure and other health problems. Patients should not stop taking olmesartan or any blood pressure medication without first discussing it with their health care professional.

This safety review was prompted by the results of the **R**andomized **O**lmesartan and **D**iabetes **M**icroalbuminuria**P**revention (or ROADMAP) trial. ROADMAP examined the effects of olmesartan in patients with type 2 diabetes, to see whether olmesartan could delay kidney damage. There was an unexpected finding of increased risk of cardiovascular death in the olmesartan group compared to the group taking a placebo. However, the risk of non-fatal heart attack was lower in the olmesartan-treated patients.

To evaluate these findings, we reviewed additional studies, including a large study in Medicare patients. Overall, we have determined that these studies do not clearly show an increased cardiovascular risk. Thus, the collective evidence available at this time does not support changing our recommendations for olmesartan use and does not support recommending that its use be avoided in patients with diabetes.

FDA posted two previous Drug Safety Communications on this issue. The first, in June 2010, described the[ongoing review of olmesartan and cardiovascular events](http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm215222.htm?ref=foodconsumer.org). The second was a [Drug Safety Communication update in April 2011](http://www.fda.gov/Drugs/DrugSafety/ucm251268.htm?ref=foodconsumer.org).

Adverse reactions involving olmesartan products can be reported to the FDA MedWatch program at[www.fda.gov/medwatch](http://www.fda.gov/medwatch?ref=foodconsumer.org)

Thank you for listening. A link to this communication, including the complete Data Summary, can be found at[www.fda.gov/DrugSafetyCommunications](http://www.fda.gov/DrugSafetyCommunications?ref=foodconsumer.org). If you have drug questions, you can reach us at[druginfo@fda.hhs.gov](mailto:druginfo@fda.hhs.gov).

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