News Brief: Labels change for HRT and candesartan cilexetil

New safety information has been added to the labels of conjugated estrogens/medroxyprogesterone acetate tablets (Prempro/Premphase) and conjugated estrogens tablets, USP (Premarin). The labeling changes reflect new risk data, primarily from the Women’s Health Initiative.

Because of the potential increased risks of cardiovascular events, breast cancer, and venous thromboembolic events, use of the drug therapies should be limited to the shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically re-evaluated. When used solely for the prevention of postmenopausal osteoporosis, alternative treatments should be carefully considered. Note that conjugated estrogens/medroxyprogesterone acetate tablets and conjugated estrogens tablets, USP are not indicated for prevention of coronary heart disease and should not be used for that purpose.

For more information, see www.fda.gov/medwatch/SAFETY/2002/safety02.htm#premar.

In other labeling changes, AstraZeneca has announced that the FDA has approved the inclusion in labeling of data from a clinical trial program showing that AstraZeneca’s angiotensin II receptor blocker candesartan cilexetil (Atacand) was superior to Merck’s angiotensin II receptor blocker losartan potassium (Cozaar) in lowering both systolic and diastolic blood pressure when administered at the maximum recommended once-daily doses. The approval follows the unanimous recommendation of the FDA Cardiovascular and Renal Drugs Advisory Committee, which concluded that candesartan cilexetil demonstrated greater antihypertensive efficacy in reducing systolic blood pressure by about 3 mm Hg and diastolic blood pressure by about 2 mm Hg compared to losartan potassium in the CLAIM clinical trial program.