FDA Black Box Warning
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY
Cardiovascular Disorders and Probable Dementia
Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis (clots in the large veins, typically in the legs), pulmonary embolism (clots in the lungs), stroke and heart attack in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (MPA) (2.5 mg), relative to placebo.
The WHI Memory Study (WHIMS) estrogen plus progestin substudy of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during four years of treatment with daily conjugated estrogen (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer. In the absence of comparable data, these risks should be assumed to be similar for other doses of conjugated estrogen and MPA, and other combinations and dosage forms of estrogens and progestins. Progestins with estrogens should be prescribed at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman.
Beware of Compounding Pharmacists
Progesterone capsules are promoted by compounding pharmacists for various uses.
Drugs compounded by pharmacists are not FDA-approved. They have not been shown to be safe or effective for use and are produced in facilities that do not have to meet good manufacturing practice guidelines.
Prometrium capsules contain peanut oil and should never be used by patients allergic to peanuts.