Council Supports Proposed FDA Requirements For Patient Labeling of Estrogens

by Council on Wage and Price Stability on November 3, 1976
by Council on Wage and Price Stability

 

Patients who receive prescriptions for estrogen should also receive label information about its effects, the Council on Wage and Price Stability said today. In a filing before the Food and Drug Administration, the Council strongly supported the FDA’s proposal to require patient-directed labeling of estrogens intended for general use. Such labels would include:

 

 

 

 

*The name of the drug

*The manufacturer

*The type and severity of conditions that indicate estrogen use

*Some conditions that should not be treated with estrogens

*The dangers of usage

*The relative risks borne by users versus nonusers.

Recent studies have shown a strong association between endometrial (lining of the uterus) cancer and the postmenopausal use of estrogens. Moreover, in the overwhelming majority of cases this drug should not have been prescribed, according to the FDA.

 

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