Guidance on Hypertension Drug Labeling

FDA has published a guidance on “Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims” that is intended to help applicants in developing labeling for cardiovascular outcome claims for hypertension drugs. “With few exceptions, current labeling for antihypertensive drugs includes only the information that these drugs are indicated to reduce blood pressure; the labeling does not include information on the clinical benefits related to cardiovascular outcomes expected from such blood pressure reduction,” the agency says, adding that it believes 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 document recommends standard labeling for antihypertensive drugs except where differences are supported by clinical data. It encourages applicants to submit labeling supplements containing the new language.