Obstetrics-Gynecology & Women's Health

First extended-cycle oral contraceptive approved

Estrogen plus progestin therapy does not prevent mild cognitive impairment (MCI) in women aged 65 years and older, and it increases the risk for probable dementia in this group, according to researchers from the Women's Health Initiative Memory Study (WHIMS).

Osteoporosis affects more than 10 million Americans and accounts for 1.5 million fractures annually. Several treatment options have been shown to prevent fractures and improve outcomes in patients with osteoporosis. Alendronate and risedronate clearly reduce fractures and are good initial choices in many patients. Raloxifene and calcitonin reduce the risk of vertebral fractures and may be appropriate in certain patients. Teriparatide was recently approved by FDA for the treatment of osteoporosis and may offer another treatment option. Combination therapy has been shown to increase bone mineral density; however, a reduction in the risk of fractures remains to be established. Zoledronic acid may offer an advantage of reduced frequency of administration.

Cases of uterine sarcoma in women receiving tamoxifen citrate (Nolvadex, AstraZeneca) have prompted a "Dear Health Professional" letter, black-box warnings on labeling, and publication of a letter to the editor in the New England Journal of Medicine from FDA officials.

NME:Once monthly IM injection; treats metastatic breast cancer after tamoxifen fails

Medications currently available to treat osteoporosis slow the rate of bone loss primarily by reducing bone resorption. The purported advantage of the anabolic agent teriparatide is that it actually promotes new bone growth. Clinical trials have shown the drug to be effective for vertebral fracture prevention in postmenopausal women at high risk. Additional evidence is accumulating to support teriparatide's use in other populations (including men) with osteoporosis. This injectable is likely to receive FDA approval in the second half of this year.

Emerging data are continually refining our understanding of the risks and benefits of hormone replacement therapy (HRT) in postmenopausal women. This review assesses the current state of evidence on these various risks and benefits, concluding with an outline of what's established and where varying degrees of uncertainty remain. Algorithms for use of HRT for several established indications are featured.

New combination, NME as component: Weekly contraceptive skin patch

NME: COX-2 inhibitor for rheumatoid arthritis, osteoarthritis, and dysmenorrhea

New Formulations/Combinations: Hormonal vaginal contraceptive ring

New Indication: Combination use with docetaxel for breast cancer; new black box

New Indication: Oral contraceptive approved for acne