Hospira Recalls Magnesium Sulfate Injection with Incorrect Barcode

Hospira has announced a voluntary recall of one lot of Magnesium Sulfate in 5% Dextrose 10mg/mL Injection after confirmed customer reports of an incorrect barcode on the primary bag labeling.

Breastfeeding Benefits, Recommended Duration Updated in Position Paper

In an updated position paper, the Academy of Nutrition and Dietetics stated that breastfeeding provides the best nutrition for infants and very young children.

Cautious Use of Prenatal Antibiotics Advised to Reduce Asthma Risk in Offspring

Women whose children are at risk for developing asthma should avoid antibiotics to the extent that they can, a study published in the Annals of Allergy, Asthma and Immunology reports.

IUD Approval Gives Women New Long-Acting Birth Control Option

The Food and Drug Administration (FDA) has approved Liletta (levonorgestrol-releasing intrauterine system; Actavis and Medicines360) for use by women to prevent pregnancy for up to three years.

Obese Women Advised Not to Gain Weight Until Mid-Pregnancy, Says Study

Pregnant women with various classes of obesity should not gain any weight until mid-pregnancy or later for optimal pregnancy outcomes, according to a new study in the journal Obesity.

Genetics May Explain Higher Birth Defects Risk in Older Mothers

Researchers at Albert Einstein College of Medicine of Yeshiva University have discovered a potential explanation as to why older mothers face a greater risk for having offspring born with conditions characterized by abnormal chromosome numbers, such as Down syndrome.

Stillbirth Delivery May Increase Long-Term Depression Risk

Women with no history of depression who deliver a stillbirth may have an increased risk for long-lasting depression, according to research.

Hypoactive Sexual Desire Disorder Drug for Women Gets Closer to Approval

Sprout Pharmaceuticals has resubmitted its New Drug Application (NDA) to the FDA for flibanserin for Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women.

New Fecal Incontinence Device Cleared for Females

The Food and Drug Administration (FDA) has granted marketing of Pelvalon's Eclipse System for the treatment of fecal incontinence in females aged 18-75 years old who have had more than four episodes in a two-week period.

Smallest Estrogen Patch Now Available for Postmenopausal Osteoporosis

Noven announced the launch of Minivelle (estradiol transdermal system) 0.025mg/day, a new low dosage strength approved for the prevention of postmenopausal osteoporosis.

Hormonal IUDs, Implants: Effective Beyond Approved Use?

Hormonal intrauterine devices (IUDs) and contraceptive implants remain effective one year beyond their approved duration of use, preliminary research has shown.

Ibrance Approved for Metastatic Breast Cancer, Now Available

The Food and Drug Administration (FDA) has granted accelerated approval to Ibrance (palbociclib; Pfizer) capsules for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease, in combination with letrozole.

Novel Cervical Retractor Device Gets FDA Clearance

Bioceptive announced it has received clearance from the Food and Drug Administration (FDA) for its suction cervical retractor for use in various gynecological procedures.

CDC: Reduce Opioid Exposure Among Reproductive-Aged Women

A new study shows the need for more interventions to reduce opioid prescriptions among women of reproductive potential, especially when safer alternatives are available or when opioid use is unnecessary.

Health Tracker Included in New Maternity Clothing Line

An undergraduate student at Cornell University has designed a collection of maternity wear that can also wirelessly monitor the mother's health using conductive silver fibers in the clothing fabric.

Folic Acid Important for NTD Prevention, Says CDC

New research by the Centers for Disease Control and Prevention (CDC) supports the protective effect of folic acid supplementation against recurrent neural tube defects (NTD).

Tarina Fe 1/20 Oral Contraceptive Now Available

Afaxys announced the availability of Tarina Fe 1/20 (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets, 1mg/20mcg/75mg) for the prevention of pregnancy in women who choose to use oral contraceptives as a method of contraception.

FDA Releases Statement on Use of Pain Meds During Pregnancy

The Food and Drug Administration (FDA) has issued a statement regarding the benefits and potential risks associated with the use of prescription and over-the-counter (OTC) pain medications during pregnancy in response to recent reports questioning their safety when used during pregnancy.

Positive Results for Elagolix in Endometriosis Study

AbbVie announced positive results from one of two ongoing Phase 3 trials for elagolix in premenopausal women with endometriosis.

Menopausal Symptoms Tied to Hip Fracture Risk

A new study shows that women who experience menopausal symptoms (eg, severe hot flashes, night sweats) tend to have lower bone mineral density and higher rates of hip fractures vs. women who do not have menopausal symptoms.

First-in-Class Drug for Advanced Ovarian Cancer Approved

The Food and Drug Administration (FDA) has granted accelerated approval for Lynparza (olaparib; AstraZeneca) for the treatment of advanced ovarian cancer associated with defective BRCA genes.

"Keepsake" Fetal Imaging May Do More Harm Than Good, FDA Warns

The Food and Drug Administration (FDA) is warning consumers that fetal ultrasound imaging and Doppler fetal ultrasound heartbeat monitors are prescription devices designed to be used by trained healthcare professionals and are not intended for over-the-counter (OTC) sale or use for creating fetal keepsake images and videos.

Chlamydia, Gonorrhea Cases Down But Syphilis Rates Up

The Centers for Disease Control and Prevention (CDC) has released its annual fact sheet of the three reported sexually transmitted diseases (STDs): chlamydia, gonorrhea, and syphilis.

FDA Expands Syphilis Screening Test Access

The Food and Drug Administration (FDA) has granted the first-ever waiver under specific laboratory regulation for Syphilis Health Check test to be used in expanded healthcare settings.

FDA Approves Gardasil 9 Vaccine

The Food and Drug Administration (FDA) has approved Gardasil 9 (9-valent human papillomavirus types, recombinant; Merck) vaccine for the prevention of cervical, vulvar, vaginal, anal cancers, and for the prevention of genital warts caused by nine types of human papillomavirus (HPV).

Once-Daily Pill for Premenstrual Breast Discomfort Available

BioPharmX announced the launch of Violet iodine, a first-of-its-kind pill for relief of premenstrual breast discomfort.

Overall Birth Rate Down, But Twin Deliveries Up

The birth rate declined in the United States for the sixth straight year in 2013, with the general fertility rate at an all-time low.

FDA: Pregnancy Categories to be Replaced with More Detailed Information

The Food and Drug Administration (FDA) has issued a final rule to standardize how information is presented in labeling of prescription drugs and biologics regarding the use of medicines during pregnancy and breastfeeding.

Laparoscopic Power Morcellators Get Safety Labeling Update

The Food and Drug Administration (FDA) is warning against the use of laparoscopic power morcellators in hysterectomy or myomectomy procedures for the majority of women.

Mother's Pre-Pregnancy Weight May Influence Offspring's Cardiovascular Risk

According to research presented at the American Heart Association's Scientific Sessions 2014, adults whose mothers were overweight or obese pre-pregnancy may have a significantly increased risk of dying from heart disease or stroke.

Lamivudine Combo Better for Preventing Maternal-Infant HIV Transmission

Taking a three-drug regimen during pregnancy prevented mother-to-child HIV transmission more effectively than taking one drug during pregnancy, another during labor, and then two more after giving birth, according to results of an ongoing international clinical trial.

Sunscreen Chemicals May Lower Fertility in Men

Certain chemicals used in sunscreens and other personal care products have been linked to reduced fecundity in men, according to a study appearing in the American Journal of Epidemiology.

Avastin Gains New Ovarian Cancer Indication

Genentech announced that the Food and Drug Administration (FDA) has approved Avastin (bevacizumab) in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer.

CitraNatal Basic, OTC Pre-Pregnancy Supplement Launched

Mission Pharmacal announced the launch of CitraNatal basic, an over-the-counter (OTC) prenatal vitamin for pre-pregnancy nutritional support.

Preterm Birth Therapy May Not Be Effective Everywhere

A standard prenatal treatment in the United States and other high-income countries for pregnant women at high risk for preterm birth may potentially cause harm if implemented in low-income countries, according to new findings.

Palbociclib + Letrozole NDA Under Review for Advanced Breast Cancer

The Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the NDA for palbociclib in combination with letrozole, as a first-line treatment of postmenopausal women with ER+, HER- advanced breast cancer who have not received previous systemic treatment for their advanced disease.

Harmful Chemicals May Penetrate Placenta During Pregnancy, Impact Thyroid Hormones

Strong evidence from a new study in human placenta suggests that Endocrine Disrupting Chemicals (EDCs) can interfere with the action of thyroid hormones in pregnant women.

Minivelle Patch Gains New Strength, New Indication

Noven announced that the Food and Drug Administration (FDA) has approved a new indication with a new dose of Minivelle (estradiol transdermal system) for the prevention of postmenopausal osteoporosis.

First OTC Conception Assistance Device Cleared

Rinovum Women's Health announced that the Food and Drug Administration (FDA) has cleared The Stork OTC, the first home-use conception assistance device.

First Male Contraceptive Injection to Undergo Testing in 2015

Vasalgel, the first male contraceptive injection, is anticipated to enter its first clinical trial beginning in 2015, according to the Parsemus Foundation.

Early Preeclampsia Detection Test Under Development

DiabetOmics announced a new point-of-care test to detect preeclampsia, assess the severity of the disease, and monitor its complications in as early as the 1st trimester.

Combination Ovarian Cancer Therapy Granted Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track designation to motolimod (VTX-2337; VentiRx) in combination with pegylated liposomal doxorubicin (PLD) for the treatment of women with ovarian cancer whose disease has progressed on or recurred after platinum-based chemotherapy.

New Prenatal Test ID's Multiple Chromosomal Abnormalities

LabCorp announced the launch of the informaSeq Prenatal Test, a non-invasive prenatal screening assay that can assess for multiple fetal chromosomal aneuploidies, or abnormalities in the number of chromosomes from a single maternal blood draw.

Palbociclib NDA Submitted for Advanced Breast Cancer

Pfizer announced that it has submitted an NDA to the FDA for palbociclib in combination with letrozole for the treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for the advanced disease.

Avastin Gains New Indication for Metastatic Cervical Cancer

Genentech has announced that the Food and Drug Administration (FDA) has approved Avastin (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent, or metastatic cervical cancer.

Similac Launches Breastfeeding Supplement for Nursing Mothers

A new Similac breastfeeding supplement is specially designed to enhance the levels of DHA, lutein, and vitamin E in breastmilk.

Neratinib Demonstrates Potential in Breast Cancer Trial

Puma Biotechnology announced results from its Phase 3 ExteNET trial of neratinib (PB272) for the extended adjuvant treatment of breast cancer.

FDA Accepts sBLA, Grants Priority Review for Avastin in Ovarian Cancer

The FDA grants Genentech's sBLA for Avastin (bevacizumab) plus chemotherapy Priority Review for the treatment of women with recurrent platinum-resistant ovarian cancer.

Priority Review, sBLA Granted for Cervical Cancer Tx

The FDA has accepted Genentech's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer.

Monistat Introduces Complete Care Products Line

Monistat announced the launch of Monistat Complete Care products, which include a vaginal health test, probiotics, and an odor-neutralizing gel.

More Fish for Pregnant, Breastfeeding Women, Says FDA

The Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) issued draft updated advice regarding the consumption of fish by pregnant and breastfeeding women and young children.

Novel PCOS Drug Granted Orphan Status

EffRx announced that the FDA has granted orphan drug designation to EX404 for the treatment of pediatric polycystic ovary syndrome (PCOS).

Chewable Prenatal Vitamins Reformulated

TherapeuticsMD announced the launch of newly reformulated vitaMedMD RediChew Rx, a branded prescription prenatal vitamin, and Prena1 Chew, a generic prescription prenatal vitamin.

High Cholesterol to Blame for Infertility?

For couples trying to conceive, high cholesterol levels may impair fertility according to a recent study published in the journal JECM.

Over Two-Thirds of U.S. Infected with HPV

A new study has found that 69% percent of healthy American adults are infected with one or more of 109 strains of the human papillomavirus (HPV).

Women More Likely Than Men to Skip Tests, Rxs, Says Survey

The 2013 Kaiser Women's Health Survey results showed how women and their health care and coverage were impacted during the Affordable Care Act (ACA) transition.

NCHS: More Older Women Having First Births

Over the past 40 years, the average age of women having first births has risen, according to a report from the National Center for Health Statistics (NCHS).

New Preconception Test to Detect Vaginal Infections

e.p.t. announced the launch of its Preconception Health Test, a new test that measures vaginal acidity and indicates the presence of infections so women can seek treatment before trying to conceive.

Gestational Diabetes Risk Linked to Liver Enzyme

Compared to women with the lowest levels, women with high levels of a common liver enzyme prior to pregnancy are twice as likely to subsequently develop gestational diabetes.

FDA Proposes Transvaginal Mesh Device Reclassification

The FDA has issued two proposed orders regarding surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) and health risks associated with this product.

First Guidelines for Managing Fetal Heart Abnormalities

The American Heart Association has released the first scientific statement on current and recommended practices of diagnosis and management of fetal cardiac disease.

First HPV Test for Primary Cervical Cancer Approved

The FDA has approved Roche's cobas HPV Test, the first human papillomavirus (HPV) DNA test for women ages >25 that can be used alone to help assess the need for additional diagnostic testing for cervical cancer.

FDA Discourages Laparoscopic Power Morcellation in Hysterectomy, Myomectomy

The FDA is discouraging the use of laparoscopic power morcellation for the removal of the uterus or uterine fibroids in women based on a recent analysis of currently available data.

New Less Invasive Vulvar Cancer Treatment Technique Possible

Sentinel lymph node dissection in women with vulvar malignancies allowed gynecologic oncology surgeons to identify and remove just the sentinel nodes and follow the patients for complications and recurrence.

Gene Variant Discovered in PCOS

The variant in the gene DENND1A has been identified as a likely stimulant for the overproduction of androgen in women with polycystic ovary syndrome (PCOS).

Low Dose Aspirin Does Not Reduce Pregnancy Loss

The National Institutes of Health (NIH) reported that daily low dose aspirin therapy did not improve birth rates in most women with prior history of one or more pregnancy losses.

Non-Ob-Gyns Deliver ~14 Percent of Routine Prenatal Care

Non-Ob-Gyn providers delivered one out of every seven routine prenatal care visits in the United States in 2009-2010.

FDA Approves Combo IVF Drugs for Infertility

Ferring Pharmaceuticals announced that the FDA has approved a new labeling for Menopur (menotropins for injection) and Bravelle (urofollitropin for injection) stating that both products can be safely mixed and administered in a single injection.

Lower HPV Uptake for Women in UK Sexual Health Services

For young women attending sexual health services in England, HPV vaccination uptake and completion rates are lower than national data.

Haemophilus Influenzae Infection Up in Pregnancy

The incidence of Haemophilus influenzae infection is increased during pregnancy, and infection correlates with poor pregnancy outcomes.

Smallest Prenatal Vitamin Now Available

TherapeuticsMD, Inc. (parent company of vitaMedMD, LLC) announced the launch of vitaPearl, the latest addition to the vitaMedMD prenatal multivitamin line.

Nicotine Patches Effective for Pregnant Smokers?

Use of nicotine patches, compared with placebo patches, does not increase the smoking cessation rate among pregnant women.

Gestational Diabetes Ups Risk of Early Atherosclerosis

Among women who have not developed diabetes or metabolic syndrome, a history of gestational diabetes mellitus (GDM) may be a marker for early atherosclerosis.

FDA Panel Recommends HPV Test As Replacement for Pap

A U.S. FDA advisory panel voted unanimously on Wednesday that a new HPV test could be used before or instead of the Pap smear as a first step in cervical cancer screening

Research Supports Alcohol Abstinence Advice Pre-Conception

Women who consume alcohol before pregnancy and during the first two trimesters are at increased risk for adverse pregnancy outcomes.

FDA Experts Debate Timing of Pap Test

A U.S. Food and Drug Administration advisory panel is considering whether to delay the Pap test and use an human papillomavirus (HPV) test as a first step in cervical cancer screening.

Low Birth Weight, SGA Linked to Female Fertility

For women born with low birth weight or small for gestational age, the odds of female-related infertility are increased.

Fewer Failures With Vaginal Mesh Repair in Prolapse With Avulsion

For women with vaginal prolapse after hysterectomy and levator ani avulsion, Prolift Total is associated with a lower anatomical failure rate than unilateral vaginal sacrospinous colpopexy with native tissue vaginal repair (sacrospinous fixation).

Transvaginal Approaches for Vaginal Prolapse

For women undergoing surgery for vaginal prolapse and stress urinary incontinence, outcomes for two common transvaginal approaches are comparable, and perioperative behavioral therapy with pelvic floor muscle training does not improve surgical outcomes

Diets May Cut Preterm Delivery Risk

Following a "prudent" or "traditional" diet is associated with a reduced risk of preterm delivery.

Yoga May Improve Menopausal Quality of Life

Yoga may improve menopause-related quality of life (QOL) in women with vasomotor symptoms.

Frameshift Mutation Identified in Premature Ovarian Failure

A frameshift mutation in a gene encoding a cohesin subunit has been identified in a large consanguineous family with premature ovarian failure.

HPV Vaccine Protects Against Cervical Abnormalities

The human papillomavirus (HPV) vaccine is effective at protecting against cervical abnormalities in young women.

Pregnancy Timing Affected by Male Phthalate Levels

High concentrations of three common forms of phthalates in men have been shown to impact fertility in couples trying to conceive.

Globulin Tied to Gestational Diabetes Risk

Low prepregnancy sex hormone-binding globulin (SHBG) concentrations correlate with increased risk of gestational diabetes mellitus.

CDC: Trends in Out-of-Hospital Births

The percentage of out-of-hospital births is continuing to increase, and in 2012 these births had a lower risk profile than hospital births.

Ordering Procedures Change Postpartum Pertussis Vaccination Rates

Changing in-hospital ordering procedures increases the postpartum pertussis vaccination rate to 69%.

Smoking, Smoke Exposure Impact Pregnancy Outcomes

Women who were ever smokers during their reproductive years and those never-smoking women with the highest levels of secondhand smoke exposure have significantly increased odds for spontaneous abortion, stillbirth, and tubal ectopic pregnancy.

Hormonal Contraceptives May Increase MS Risk

Use of hormonal contraceptives may be contributing to the increasing incidence of MS in women.

Fertility Concerns for Young Women With Breast CA

Fertility concerns are common among young women with newly diagnosed breast cancer, although only a minority pursue fertility preservation strategies.

Prenatal DNA Test Bests Standard Screening in General Population

Maternal plasma cell-free DNA (cfDNA) sequencing for trisomies 18 and 21 gives 5-10 fold higher positive predictive values than standard aneuploidy screening.

In-Hospital Formula Impacts Breastfeeding

Use of supplementation with in-hospital formula shortens the duration of breastfeeding among first-time mothers who intend to breastfeed exclusively

Hysterectomy, Ovary Removal Linked to Diabetes

Postmenopausal women are at higher risk of developing diabetes if they have both a hysterectomy and bilateral oophorectomy.

Acetaminophen Use in Pregnancy May Up Risk for Child's ADHD

Children whose mothers took acetaminophen during pregnancy are at a higher risk for developing hyperkinetic disorders (HKDs) and attention-deficit/hyperactivity disorder (ADHD)-like behavioral problems.

HPV Vaccination Impacts Lesion Risk

Vaccination with the quadrivalent HPV vaccine is associated with reduced risk of atypia or worse (atypia+) or cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3).

Fever During Pregnancy Associated With Birth Defects

Fever during pregnancy is associated with adverse health outcomes for the offspring.

FDA Panel to Review Oocyte Modification Therapy

An FDA panel will review information on mitochondrial manipulation to prevent mitochondrial diseases and to treat infertility.

Preventive Pediatric Health Care Recommendations Updated

Recommendations for preventive pediatric health care have been updated, according to an American Association of Pediatrics (AAP) policy statement.

Obstetricians Target Primary Cesarean Delivery Rate

Primary cesarean delivery rates can be safely reduced by implementing various interventions, according to an ACOG consensus statement.

Intensive Dialysis Improves Pregnancy Outcomes

For women with end-stage renal disease (ESRD), intensive hemodialysis is associated with improved pregnancy outcomes.

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