Obstetrics-Gynecology & Women's Health

FDA has approved doxylamine succinate 10 mg, pyridoxine hydrochloride 10 mg (Diclegis, Duchesnay) delayed-release tablets for the treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management, including dietary and lifestyle modifications. These modifications include eating several small meals instead of 3 large meals, eating bland foods that are low in fat and easy to digest, and avoiding smells that can trigger nausea.

FDA voted 2-12 against approval for an investigational, oral, twice-daily formulation of gabapentin (Sefelsa, Depomed) to treat moderate to severe vasomotor symptoms due to menopause.

FDA has approved ospemifene (Osphena, Shionogi) tablets for the treatment of moderate to severe dyspareunia (painful intercourse), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.

High intakes of calcium in women are associated with higher death rates from all causes and from cardiovascular disease, but not from stroke. This is the conclusion of a prospective longitudinal cohort study conducted by researchers in Sweden and published in the British Medical Journal.

A study by Norwegian researchers has shown that the use of folic acid supplements around the time of conception may lower the risk of autism in children. The study was published in the February 13, 2013, issue of The Journal of the American Medical Association.

The National Breast Cancer Coalition recently awarded a nearly $200,000 seed grant to two researchers who will study the viral connection to breast cancer. The research will assess the infectious agent in breast tumors compared to normal breast tissue, which could lead to a preventive vaccine.

An FDA advisory panel recommended in late June that Avastin should not be used to treat breast cancer.

FDA is assessing new information indicating an association between birth control pills containing the progestin hormone drospirenone and an increased risk of deep vein thrombosis and pulmonary embolus.

A look at the therapeutic pipeline for glaucoma shows several medications representing new pharmacologic classes are currently being evaluated in clinical trials, said John R. Samples, MD, at ASCRS Glaucoma Day 2011, San Diego.

A newly developed assay can measure the ability of antibiotics to associate with mammalian cells and protect the cells from bacterial destruction. Of 4 antibiotics tested in this assay, the data showed a range of therapeutic effectiveness in 2 cell lines that clinicians can consider when establishing dosing regimens, according to Jeremy Wingard, MD, who reported his group's findings at the American Society of Cataract and Refractive Surgery annual meeting, San Diego.

First-trimester exposure to antiepileptic drugs compared with no exposure does not appear to increase the risk of major birth defects, according to a Danish study, published in the May 18 issue of the Journal of the American Medical Association.

Medication use among pregnant women is widespread and increasing, according to a recent study from the Boston University School of Public Health in Boston.

The American Heart Association recently released its updated cardiovascular disease prevention guidelines for women. The guidelines emphasize practical medical advice that works in the "real world" rather than on findings primarily observed in clinical research.

The administration of vaginal progesterone from the mid-trimester of pregnancy until term in women with a premature cervical shortening as confirmed by transvaginal ultrasound significantly reduced the rate of preterm birth before 33 weeks gestation, according to a phase 3 study published online April 6 in Ultrasound in Obstetrics & Gynecology.

FDA said it wouldn't take action against compounding pharmacies that continue to supply 17 alpha hydroxyprogesterone caproate (Makena, KV Pharmaceutical, Ther-Rx).

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.