The FDA has announced that combination hormonal contraceptives (CHCs) containing the synthetic progestin drospirenone (Yaz, Yasmin, Beyaz, Safyral, and others) may be associated with a higher risk of thromboembolism than CHCs containing other progestins.1The new warning was based partly on an unpublished, FDA-funded, retrospective study that found a 1.7-times higher risk of venous thromboembolism among US women who used a CHC that contained drospirenone than among women whose CHC contained levonorgestrel, norgestimate or norethindrone as the progestin component.2 As with all retrospective...

Two types of oral contraceptives are available in the USA: combination oral contraceptives that contain both an estrogen and a progestin, and progestin-only contraceptives, or "mini-pills."Used as directed, all oral contraceptives marketed in the USA are similarly effective in preventing pregnancy.

A combination tablet containing estradiol and drospirenone (Angeliq - Berlex) recently became available for treatment of moderate to severe menopausal symptoms in women with an intact uterus. Since the last Medical Letter issue reviewing such devices,1 more continuous glucose monitoring (CGM) systems have become available. Five devices available now, and two expected to be marketed soon, are listed in the table on page 14. The FDA has approved continuous glucose devices only for the observation of glucose trends.

The FDA has approved Opill (Perrigo), a progestin-only oral contraceptive that contains norgestrel, for sale over the counter (OTC). Opill is the first oral contraceptive to be approved in the US for sale without a prescription. Approval of OTC Opill is intended to increase access to effective contraception and reduce the rate of unintended pregnancies.

The FDA has approved a new low-dose estrogen patch (Menostar - Berlex) for prevention of osteoporosis in postmenopausal women. Unlike other estrogen patches, it is not approved for treatment of hot flashes or other menopausal symptoms. Promotional material from the manufacturer suggests that this low dose of estrogen could prevent osteoporosis without some of the adverse effects of higher doses.

Estrogen is the most effective treatment for menopausal vasomotor symptoms (hot flashes), but the Women's Health Initiative study found that women who took estrogen plus a progestin for more than 5 years were at increased risk for myocardial infarction, stroke, pulmonary emboli, deep vein thrombosis, breast cancer, and possibly dementia. Are there effective alternatives?

The FDA has approved the marketing of Natazia (Bayer), a 4-phase oral contraceptive containing the estrogen estradiol valerate and the progestin dienogest, both used for the first time in the US for this indication.

The FDA has approved Duavee (Pfizer), a fixed-dose combination of conjugated estrogens and the new selective estrogen receptor modulator (SERM) bazedoxifene, for treatment of moderate to severe vasomotor symptoms and for prevention of osteoporosis in postmenopausal women with an intact uterus. Bazedoxifene is an estrogen agonist/antagonist with estrogen-like effects on bone and antiestrogen effects on the uterus. It is the second SERM to be approved for prevention of osteoporosis; raloxifene (Evista, and generics) has been available as a single agent for this indication since...

Intrauterine devices (IUDs) and the etonogestrel implant are the most effective reversible contraceptive methods available. Hormonal oral contraceptives, patches, rings, and injectables are also effective in preventing pregnancy. When used alone, barrier and behavioral methods generally have higher failure rates than other methods (see Table 1). Selection of a contraceptive method is usually based on patient-specific factors and personal preference

High doses of estrogens, with or without a progestin, have been used for many years to prevent pregnancy after unprotected coitus (Medical Letter, 31:93, 1989). Now the FDA has approved marketing of the Preven Emergency Contraceptive Kit (Gynetics, Inc.) for this indication. The kit, which will require a prescription, includes four tablets, each containing 50 g of ethinyl estradiol and 0.25 mg of levonorgestrel, and a pregnancy test to rule out a pre-existing pregnancy, which would be a contraindication to taking the hormones.