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.
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.
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.
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 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.
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 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.
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.
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.