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# Hypertension Indication Labeling Guidance
- URL: https://www.fdaweb.com/hypertension-indication-labeling-guidance/
- Published: 2020-01-30T12:00:00.000Z
- Updated: 2026-09-14T16:00:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145972

FDA has issued a guidance, *Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims*, to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. With few exceptions, the [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension-indication-drug-labeling-cardiovascular-outcome-claims?ref=fdaweb.com) says, current labeling for antihypertensive drugs includes only the information that the drugs are indicated to reduce blood pressure and does not include information on the clinical benefits related to cardiovascular outcomes expected from such blood pressure reduction.

The guidance says FDA believes that appropriate use of the drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling. It recommends standard labeling for antihypertensive drugs except where differences in labeling are supported by clinical data.