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.