Obstetrics-Gynecology & Women's Health

New molecular entity

July 04, 2013

In April 2013, FDA approved doxylamine succinate 10 mg, pyridoxine hydrochloride 10 mg (Diclegis, Duchesnay) for the treatment of nausea and vomiting in pregnant women who do not respond to conservative management. Diclegis is a delayed-release formulation combining 10 mg of the antihistamine doxylamine succinate and 10 mg of the vitamin B6 analog pyridoxine hydrochloride. This combination was once marketed in the United States as Bendectin. However, legal suits claiming related birth defects forced the manufacturer to withdraw Bendectin from the market in the 1980s. Doxylamine/pyridoxine has not been studied in women with hyperemesis gravidarum.

Women at increased risk for opioid-related death

July 02, 2013

Opioid overdose deaths in women in the United States increased fivefold from 1999 to 2010. During the same time period, the risk of opioid pain reliever (OPR) deaths in men increased 3.6 times, according to the July 2 Morbidity and Mortality Weekly Report.

FDA officially approves Plan B One-Step for all women

June 21, 2013

FDA announced it has approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential. This action complies with the April 5, 2013 , order of the United States District Court in New York to make levonorgestrel-containing emergency contraceptives available as an over-the-counter (OTC) product without age or point-of-sale restrictions.

Plan B One-Step restrictions are lifted

June 11, 2013

The Obama administration on Monday abandoned its attempt to restrict access to the emergency contraceptive Plan B One-Step (Teva Women’s Health Inc.) as an over-the-counter (OTC) medication-a decision that’s being celebrated by some groups.

FDA warns against prolonged use of magnesium sulfate to stop preterm labor

June 04, 2013

FDA advised healthcare professionals not to use magnesium sulfate injection for more than 5-7 days to stop preterm labor in pregnant women, according to a May 30 drug safety communication.

USPSTF advises against vitamin D, calcium to prevent fractures in adults

May 28, 2013

After its recent review, the US Preventive Services Task Force (USPSTF) could not recommend supplementation with vitamin D and calcium for the primary prevention of fractures in healthy adults.

FDA warns pregnant women to not use certain migraine prevention medicines containing valproate

May 08, 2013

Migraine prevention drugs used during pregnancy can cause decreased IQ scores in children born to mothers who take these medications, according to an FDA alert.

Women at highest risk for breast cancer benefit most from preventive therapy

April 17, 2013

Women at the highest risk for breast cancer benefit the most from preventive drug therapy, including tamoxifen and raloxifene, according to a study, published in the April 16, 2013, issue of the Annals of Internal Medicine.

Age restriction on emergency contraception lifted

April 10, 2013

On April 5, a US District Court judge ruled that the emergency contraception (EC) pill Plan B One-Step must be made available over-the-counter to all girls and women, regardless of their age. This ruling, made by Judge Edward R. Korman, was in response to a 2011 move by Health and Human Services Secretary Kathleen Sebelius.

FDA approves Diclegis for treatment of pregnancy morning sickness

April 09, 2013

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 panel rejects menopause drug

March 05, 2013

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 approves treatment for postmenopausal women experiencing pain during intercourse

February 27, 2013

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 calcium intake linked to CVD in women

February 25, 2013

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.

Prenatal folic acid may lower risk of autism

February 19, 2013

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.

Breast cancer vaccine possibility to be studied through grant

February 14, 2013

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.

FDA panel recommends withdrawing Avastin indication for breast cancer treatment

July 08, 2011

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

FDA reviews safety of drospirenone for increased DVT, PE risk

June 17, 2011

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.

Hope for advances in glaucoma management fueled by promising pipeline

May 27, 2011

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.

New assay helps determine antibiotic efficacy for ocular surface infections

May 27, 2011

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.