Obstetrics-Gynecology & Women's Health

FDA "...does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products," according to a statement.

FDA recently announced that the 'Pregnancy' sections of labeling for all antipsychotic medications will now have to include wording about the potential risk for extrapyramidal side effects and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

New indication: Hydroxyprogesterone caproate injection was approved by FDA in February to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of at least 1 spontaneous preterm birth.

Despite advancements, treatment of metastatic breast cancer hinges on multifarious factors and numerous unanswered questions about therapy linger. Agents that are highly active in heavily pretreated patients are needed to optimize outcomes in patients with metastatic disease. This article reviews current and novel treatment options for metastatic breast cancer.

The risk of certain birth defects is higher in women given opioid analgesics such as hydrocodone during pregnancy, according to a new study.

FDA is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor because of the risk for serious maternal heart problems and death.

FDA has approved hydroxyprogesterone caproate injection (Makena [formerly known as Gestiva], Hologic and KV Pharmaceutical Co.), the first drug to help prevent premature delivery before 37 weeks in women who have had at least 1 previous preterm birth.

Escitalopram, a selective serotonin reuptake inhibitor, at doses of 10 or 20 mg/d significantly reduced hot flash frequency and severity compared with placebo, according to a recent multi-center, double-blind study.

New molecular entity: Risedronate sodium delayed-release tablets (Atelvia) were approved for the treatment of postmenopausal osteoporosis

This review discusses current contraceptive options including recently approved, newer agents.

Twenty-four-day oral contraceptive regimens containing a progestogen with a long half-life shows higher contraceptive effectiveness under routine medical conditions compared with conventional 21-day regimens, according to research published in the January 2011 issue of Obstetrics & Gynecology.

A combination of lapatinib, trastuzumab, and paclitaxel significantly improved tumor response rates in patients with human epidermal growth factor receptor 2-positive breast cancers, according to a new study presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium, San Antonio, Texas.

New indication: Denosumab (Xgeva) has been approved for prevention of skeletal-related events from bone metastases from solid tumors.

As compared to fluorouracil, doxorubicin, and cyclophosphamide, an adjuvant taxane-based regimen containing docetaxel, doxorubicin, and cyclophosphamide was shown to increase the rate of disease-free survival by 32% among women with high-risk, node-negative breast cancer.

A newly approved drug, denosumab (Xgeva, Amgen), delays skeletal-related side effects for 5 months longer compared to zoledronic acid (Zometa and Reclast, Novartis) in patients with breast cancer and bone metastases, according to phase 3 trial results presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium, San Antonio, Texas.

Women who suffer from endometriosis-related pain should be treated first with conservative, non-surgical approaches and then with more invasive options if pain does not resolve, and hysterectomy only as a last resort, according to a practice bulletin issued by the American College of Obstetricians and Gynecologists (ACOG) and published in the July issue of Obstetrics & Gynecology, reported HealthDay News.

New Molecular Entity: Denosumab (Prolia) was approved in June as a treatment for postmenopausal osteoporosis in women at high risk for fracture.

Initial results of the Women's Health Initiative (WHI) study demonstrated an increased risk of breast cancer among postmenopausal women treated with estrogen plus progestin. A new long-term analysis of this study published in the New England Journal of Medicine demonstrated that breast cancer incidence decreased markedly after WHI study participants discontinued hormone therapy.

The Long-Term Intervention on Fractures with Tibolone (LIFT) study demonstrated a reduced risk of vertebral fracture, breast cancer, and possibly colon cancer but a significantly increased risk of stroke in older postmenopausal women treated with tibolone versus those treated with placebo.

Treatment options for osteoporosis include calcium, vitamin D, estrogen plus progesterone, calcitonin, and bisphosphonates.

Adding bevacizumab to treatment with paclitaxel does not prolong overall survival among patients with metastatic breast cancer; however, the combination therapy is associated with a significant improvement in progression-free survival, according to the results of a trial published in the New England Journal of Medicine (NEJM).

Ixabepilone was approved on October 16, 2007, as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine; and in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated.

In 2 large, case-control studies published in the New England Journal of Medicine (NEJM), researchers demonstrated that, overall, a woman's use of a selective serotonin-reuptake inhibitor (SSRI) in early pregnancy was not associated with significantly increased risks of congenital heart defects or most other types of birth defects.

Raloxifene was approved on September 13, 2007, for the additional indication of the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer.

In the large cohort study referred to as the "The Million Women Study," the use of hormone replacement therapy (HRT) in postmenopausal women was demonstrated to increase the risk of ovarian cancer and death from ovarian cancer by 20% and 23%, respectively, compared to nonuse of HRT.

Three-year results of the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly (HORIZON) Pivotal Fracture Trial show that a single, annual intravenous infusion of zoledronic acid can decrease risk of vertebral fracture by 70% and the risk of hip fracture by 41% among women with osteoporosis.

In a nested case-control study, the use of low-to-moderate doses of aspirin (ASA) in women was associated with a significant reduction in all-cause mortality.

A new formulation/dosing regimen for levonorgestrel 90 mcg/ethinyl estradiol 20 mcg, a continuous-use combination oral contraceptive approved by FDA for the prevention of pregnancy.

Oral estrogen use in postmenopausal women may elevate the risk of venous thromboembolism (VTE); however, the use of transdermal estrogen does not appear to increase the risk of VTE.

A phase 3 study evaluating the use of gabapentin alone and in combination with an antidepressant in women with hot flashes who had an inadequate response with antidepressant monotherapy demonstrated that gabapentin reduced hot flashes by approximately 50%, whereas the combination of an anti-depressant with gabapentin appeared to offer no additional benefit.