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# Hypertension Labeling for Cardio Claims Guidance
- URL: https://www.fdaweb.com/hypertension-labeling-for-cardio-claims-guidance/
- Published: 2023-01-03T12:00:00.000Z
- Updated: 2026-09-14T18:10:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153438

FDA has published 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. The [document](https://www.fda.gov/media/134777/download?ref=fdaweb.com) says that with few exceptions, current labeling for antihypertensive drugs does not include information on the clinical benefits related to cardiovascular outcomes expected from blood pressure reduction.

“FDA believes that the appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling,” the guidance says. “This guidance recommends standard labeling for antihypertensive drugs except where differences in labeling are supported by clinical data. We encourage applicants to submit labeling supplements containing the new language.”

The guidance contains Introduction, Background, Justification for Adding Outcome Claims to Labeling, Labeling Recommendations, Drug Classifications for Antihypertensive Drugs, Cardiovascular Outcome Claim Considerations, Paperwork Reduction Act of 1995, and References.