The FDA has approved a low-dose formulation of the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate (Brisdelle – Noven Therapeutics) for treatment of moderate-to-severe vasomotor symptoms associated with menopause. It is the first non-hormonal therapy to be approved for this indication. Paroxetine mesylate (Pexeva) and paroxetine hydrochloride (Paxil, and generics) are marketed in higher doses for treatment of depression and other psychiatric disorders.

Anastrozole (Arimidex - AstraZeneca, Medical Letter 1996; 38:61), an aromatase inhibitor, has received accelerated approval from the FDA for adjuvant treatment of postmenopausal women with early hormone-receptor-positive breast cancer. The drug was approved for treatment of postmenopausal women with metastatic breast cancer in 1996.

A high-intensity, narrow-band blue light (ClearLight -Lumenis) approved by the FDA for treatment of moderate inflammatory acne vulgaris has been featured in some stories in fashion magazines. This review describes the etiology and treatment of acne, as well as the mechanism of action, clinical studies, adverse effects, dosage and cost of the drug.

The most important prognostic variable in early breast cancer is axillary lymph node involvement. Based on past experience, after 10 years about 70% of node-negative patients will be alive and apparently free of disease; about 30% will have relapsed or died. Patients with positive nodes may have a 30% to 60% relapse rate, depending on the number of positive nodes and other prognostic factors, such as the presence of estrogen receptors (IC Henderson et al, in VT DeVita, Jr et al, eds, Cancer: Principles and Practice of Oncology, 3rd ed, Philadelphia:Lippincott, 1989, p 1197). Which of...

The FDA has approved a combination oral contraceptive containing the estrogen estetrol and the progestin drospirenone (Nextstellis – Mithra/Mayne). Estetrol is the first new estrogen to become available in the US in 50 years. Drospirenone is available alone (Slynd) and in combinations with the estrogen ethinyl estradiol for prevention of pregnancy.

Two new topical testosterone products, a 1% gel (Testim) and a buccal tablet (Striant), have been approved by the FDA for treatment of hypogonadism in men. This review briefly describes hypogonadism and its causes and lists other available formulations of testosterone. For the new products, information on pharmocokinetics, adverse effects, and dosage and administration is provided, as well as a summary of clinical trial results. A dosage and cost table for topical testosterone products is also included. The conclusion summarizes the safety and effectiveness of the new drugs and discusses the...

Fulvestrant (Faslodex -- AstraZeneca), an estrogen receptor antagonist given intramuscularly (IM) once a month, was recently approved by the FDA for treatment of hormone-receptor-positive metastatic breast cancer in postmenopausal women with disease progession on tamoxifen (Nolvadex, and others) or another antiestrogen.

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...

Primary hypothyroidism is usually the result of Hashimoto's (autoimmune) thyroiditis, thyroidectomy, or radioactive iodine therapy. Treatment of hypothyroidism with replacement doses of thyroid hormone is usually lifelong. Levothyroxine (LT4; synthetic thyroxine; Synthroid, and others) is the drug of choice.1

The FDA has approved sacituzumab govitecan-hziy (Trodelvy – Immunomedics), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with metastatic triple-negative breast cancer who have received ≥2 prior therapies for metastatic disease. It is the first Trop-2-directed antibody-drug conjugate to become available in the US.