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# FDA Denies Olmesartan Withdrawal Petition
- URL: https://www.fdaweb.com/fda-denies-olmesartan-withdrawal-petition/
- Published: 2019-10-09T12:00:00.000Z
- Updated: 2026-09-15T01:55:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145210

FDA has denied a Public Citizen 11/15/17 petition asking that it immediately remove from the market all medications containing the angiotensin II receptor blocker olmesartan medoxomil, including branded drugs Azor, Benicar, Benicar HCT, and Tribenzor, as well as all generic versions of the drugs. FDA’s denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-6513-0016&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says Public Citizen sought the withdrawal because: 

- olmesartan medoxomil is associated with a risk of sprue-like enteropathy, and
- multiple other angiotensin II receptor blockers that do not have the same risk have been approved by FDA to treat hypertension.

The letter says FDA reviewed the literature cited by Public Citizen to support its petition and the FAERS data on adverse events associated with drug products containing olmesartan medoxomil. “We have determined,” the agency writes, “based on the information currently available to us, that initiating the withdrawal of the marketing approval of drug products containing olmesartan medoxomil for reasons of safety is not warranted at this time. The safety concerns you raise in the petition were appropriately and thoroughly considered in 2013 when a Drug Safety Communication was issued, and updated Warnings were approved in the labeling of drug products that contain olmesartan medoxomil. Since then, there have been no new safety findings from FDA’s ongoing surveillance, or raised in the petition, that sufficiently alter the risk/benefit analysis of drug products containing olmesartan medoxomil to necessitate the removal of these products from the market.”