Alternate Confirmation Test for Essure Gets Nod from FDA

Bayer HealthCare announced that the Food and Drug Administration (FDA) has approved an alternate confirmation test for Essure inserts, administered three months following the procedure for hysteroscopic sterilization.

Obese Teens Less Likely to Use Contraception Than Peers

There appears to be a difference in contraception use among female adolescents based on weight, as new research appearing in the Journal of Pediatrics found that sexually active obese adolescents were significantly less likely to use contraception compared to their normal weight peers.

FDA Approves New Combination Oral Contraceptive

The Food and Drug Administration (FDA) has approved Tri-Lo-Estarylla (ethinyl estradiol, norgestimate; Sandoz) tablets for oral contraception.

C-Section and Autism Risk: Are They Related?

Children who were born via cesarean section delivery were 21 percent more likely to be diagnosed with autism spectrum disorder (ASD) but this link was not found to be causal upon further analysis of sibling pairs, new research has found.

New Pelvic Muscle Training Device Available for Urinary Incontinence

The PeriCoach System is now available to strength and tone pelvic muscles in women with urinary incontinence following its approval in March 2015.

Swift Birth Control Implantation Postpartum Could Have Big Financial Savings

A computer model predicts that offering women immediate postpartum etonogestrel implant insertion could be extremely cost-effective for both new mothers and medical insurance companies.

ADHD Drug Helps Women With Menopause-Related Cognitive Issues in Study

A drug indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and binge eating disorder also helped women with executive functions related to menopause in research appearing in the journal Psychopharmacology.

Women Wishing to Conceive May Want to Avoid These Pain Meds, Study Suggests

A study presented at the European League Against Rheumatism Annual Congress (EULAR 2015) indicates that use of some non-steroidal anti-inflammatory drugs (NSAIDs) could have a negative impact on female fertility, even with short-term use.

Does Eating Placenta Really Help Moms Postpartum?

Interest in potential health benefits with consuming the placenta postpartum has increased in recent years, but a review in the Archives of Women's Mental Health found inconclusive data on the perceived health benefits with placentophagy.

Third Time's a Charm for Female Libido Drug Flibanserin

The Food and Drug Administration (FDA) Advisory Committee has voted 18-6 in favor of approving flibanserin, an investigational agent for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women if certain risk management options beyond labeling are implemented.

SSRI Use in Late Pregnancy Linked to PPHN, But Risk is Small

While a new study appearing in the Journal of the American Medical Association suggests that use of antidepressants in late pregnancy may be associated with an increased risk of persistent pulmonary hypertension of the newborn (PPHN), the absolute risk is small and the risk increase appears to be less than previous studies have suggested.

Antiviral Prevents Mother-to-Infant Transmission of HBV in Study

Research published in Clinical Gastroenterology and Hepatology showed that nearly all pregnant women with hepatitis B virus (HBV) taking telbivudine had undetectable levels of HBV DNA in cord blood, with no severe adverse events or complications observed in women or infants.

Do Vitamin D, Calcium Supplements Reduce Menopausal Symptoms?

Vitamin D and calcium supplements do not appear to reduce menopausal symptoms in older women, reports a new study published in Maturitas, the official journal of the European Menopause and Andropause Society.

APAP Use During Pregnancy May Have Adverse Effect on Male Babies

Prolonged acetaminophen use (1 week) by pregnant women may suppress fetal testosterone production, according to researchers from the University of Edinburgh.

Drop in Codeine Rx to Postpartum Women Seen After FDA Advisory

A new study in JAMA reports that a significant reduction in the rate of dispensing of codeine to postpartum women was observed following public health advisories from the U.S. Food and Drug Administration (FDA) and Health Canada on potentially life-threatening adverse effects in infants of breastfeeding mothers taking codeine.

Study: 9-Valent HPV Vaccine Could Prevent 80% of Cervical Cancers

A study by the Centers for Disease Control and Prevention (CDC) and Cedars-Sinai proposes that the 9-valent human papillomavirus (HPV) vaccine could prevent 80 percent of cervical cancers in the United States if administered to all 11- or 12-year-old children prior to exposure to the virus.

E-Reminders at Office Visit May Boost HPV Vaccination Rates

A simple electronic reminder during an office visit may encourage more patients to get the human papillomavirus (HPV) vaccine to protect against cervical cancer, researchers have found.

New Human Donor Milk Can Be Stored at Room Temperature

Medolac Laboratories and the Mothers Milk Cooperative announced the launch of Co-op Donor Milk, the first direct-to-consumer human donor milk that can be stored at room temperature.

Essure's Long-Term Safety, Efficacy Announced in Study

Bayer HealthCare announced results from a study that support previous findings on the effectiveness and safety of the Essure inserts and procedure for hysteroscopic sterilization.

First-of-Kind Rapid Pregnancy Blood Test Cleared by FDA

Abbott announced that the Food and Drug Administration (FDA) has granted clearance for the i-STAT Total β-hCG blood test to detect if a woman is in the early stages of pregnancy.

High-Dose Creams More Effective for Genital Warts, Reports Study

A high-dose treatment of sodium nitrite and citric acid creams applied twice daily was more effective than placebo for treating anogenital warts, according to a new study in JAMA Dermatology.

Cranberries May Be as Effective in UTI Prevention as Antibiotics, Study Finds

Cranberry extract may lower the risk of urinary tract infection (UTI) by 50% in women who have a catheter in place while undergoing elective gynecological surgery.

FDA Designates Cantrixil Orphan Drug for Ovarian Cancer

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Cantrixil (TRXE-002; CanTx Inc.) for ovarian cancer.

Severe "Morning Sickness" May Increase ADHD, Anxiety Risk in Offspring

In utero exposure to hyperemesis gravidarum (HG) is linked to a three-fold increase in risk of a neurodevelopmental diagnosis such as attention deficit hyperactivity disorder (ADHD), reports the first study to examine this relationship.

Greater Chance of Twins Seen for Female Smokers With Genetic Variant

Researchers may have discovered a mechanistic explanation and preliminary evidence to support previous findings that mothers of twins are more likely to have smoked, despite smoking's potential deleterious effects on fertility.

Gestational Diabetes May Impact Child's Autism Risk

In a study published in JAMA, intrauterine exposure to gestational diabetes by 26 weeks was linked to a risk of autism spectrum disorders (ASDs).

The Rx Opioid Epidemic Is Affecting Infants Too

Researchers from Vanderbilt University Medical Center have found that most babies exposed to opioid pain relievers were more likely to be preterm, have complicated births, low birth weight, and have meconium aspiration syndrome and respiratory distress.

Liletta Available to Prevent Pregnancy for up to 3 Years

Actavis and Medicines360 announced the launch of Liletta (levonorgetsrel-releasing intrauterine system) 52mg for the prevention of pregnancy for up to 3 years.

IUDs, Implants Becoming More Popular Among Teens

Use of long-action reversible contraception (LARC), such as intrauterine devices (IUDs) and implants, increased from 2005-2013 among teens aged 15-19 seeking contraceptive services, according to the Centers for Disease Control and Prevention (CDC)'s Morbidity and Mortality Weekly Report (MMWR).

Ovarian Cancer Therapy Granted Breakthrough Therapy Designation

The FDA has granted Breakthrough Therapy designation to rucaparib (Clovis Oncology) as monotherapy treatment of advanced ovarian cancer in patients who have received at least two lines of prior platinum-containing therapy, with BRCA-mutated tumors, inclusive of both germline BRCA (gBRCA) and somatic BRCA (sBRCA) mutations.

Why It's Important to Skip the Junk Food in Late Pregnancy

Overconsumption of junk food late in pregnancy may be more harmful to the child than excess junk food early in the pregnancy, researchers from the University of Adelaide have shown.

Accurate BP Readings Vital to Early Preeclampsia Detection, Urges Review

A review published in The Obstetrician & Gynaecologist emphasizes that accurate blood pressure measurement is vital to the early diagnosis of hypertensive disorders in pregnancy.

Wireless Fetal Monitoring System Now Cleared for Home Use

AirStrip announced that the Food and Drug Administration (FDA) has cleared the AirStrip Sense4Baby wireless maternal/fetal monitoring system for use by pregnant patients to self-administer non-stress tests (NST).

AIUM: Ultrasound Should Be First-Line for Pelvic Imaging

Ultrasound is more cost-effective and safer than other imaging technologies for imaging the female pelvis and it should be the first modality used for patients with pelvic symptoms, advocates of the American Institute of Ultrasound in Medicine (AIUM) have proposed.

Glyburide Use in Moms May Up Neonatal Adverse Events

Glyburide use in mothers with gestational diabetes mellitus (GDM) was associated with an increased risk for newborns to be admitted to an intensive care unit, have respiratory distress, hypoglycemia, birth injury, and be large for gestational age compared to infants born to women treated with insulin.

Studies Report Positive Impact of Walnuts in Multiple Health Conditions

Multiple studies have shown that walnuts may have a positive impact on important health conditions such as colon cancer, cognitive aging, and gut and vascular health.

Endo Society Supports Thyroid Screening for Some Women

The Endocrine Society has issued a response to the USPSTF's final recommendation statement on screening for thyroid dysfunction.

Study: Pregnant, Breastfeeding Women Not Consuming Enough of This Nutrient

Results from a large birth cohort study suggest women may not be consuming enough omega-3 to meet the recommendations for pregnancy and lactation.

First-in-Class Test to Aid IVF Embryo Selection Approved

Auxogyn announced the availability of the Eeva Test to help the embryo selection process by taking images of the embryos during the incubation period.

First Response Women's Multivitamin Line Coming Soon

Church & Dwight announced the expected launch of First Response Reproductive Health Multivitamin Gummies and PreNatal & PostNatal Multivitamin Gummies, an extension of the First Response product line.

CV Protection With HRT + Statins May Depend on Estrogen Type

Hormone therapy combined with statins may help protect women from heart disease or stroke after menopause, data from a Swedish population study has shown.

New OTC Emergency Contraceptive Launched

Afaxys announced the launch of EContra EZ (levonorgestrel) tablet, an over-the-counter (OTC) emergency contraceptive.

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.

Wider Availability of Emergency Contraceptive Announced

Afaxys announced the wider availability of ella (ulipristal acetate), an emergency contraceptive, after acquiring U.S. marketing rights.

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).

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