Weight Gain Concerns May Impact Birth Control Choice

Concerns about gaining weight may impact contraception choices for women.

FDA Approves Intrarosa for the Treatment of Dyspareunia

The FDA has approved Intrarosa (prasterone; Endoceutics) for the treatment of women experiencing moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

FDA: New Warnings for Permanent Birth Control Device

The labeling now includes a new Boxed Warning and a Patient Decision Checklist.

FDA Approves Bonjesta for Pregnancy-Related Nausea and Vomiting

The Food and Drug Administration (FDA) has approved Bonjesta (doxylamine succinate and pyridoxine HCl extended-release tablets; Duchesnay), a fixed-dose combination drug product for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

​Allergan Launches First COC Softgel Capsule

Allergan announced the availability of Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, the first oral contraceptive in a softgel capsule for the prevention of pregnancy.

Does Fracture Risk Go Up After Stopping Hormone Therapy?

For women who are former hormone therapy users, risk of fracture is not increased after discontinuing therapy, according to a study published in the The Journal of Clinical Endocrinology & Metabolism.

Positive Results for On-Demand Hypoactive Sexual Desire Disorder Drug

Palatin has announced positive top-line results from the Phase 3 clinical trial of bremelanotide (a melanocortin 4 receptor agonist), an investigational treatment for hypoactive sexual desire disorder (HSDD).

New Molecular Test Cleared to Detect Vaginitis Causes

BD announced that the Food and Drug Administration (FDA) has granted marketing clearance for BD MAX Vaginal Panel to detect the most common causes for vaginitis.

Recall of Estrogen Tabs Announced

Pfizer announced a voluntary recall of one lot of Premarin (conjugated estrogens) 1.25mg tablets due to an incorrect expiration date applied to the bottle label.

Contraceptive Patch vs. Pill: Thrombosis Risk Explored

A new study published online in the journal Contraception examines whether the risk of venous thromboembolism (VTE) and arterial thromboembolism (ATE) is increased in women using non-oral combined hormonal contraceptives compared to women using combined oral contraceptives (COC).

Positive Results for Elagolix in Two Endometriosis Studies

AbbVie has announced positive results from two replicate Phase 3 clinical trials of Elagolix in premenopausal women with endometriosis.

Menest Dosage Strength Discontinued

The Food and Drug Administration (FDA) reports the discontinuation of Menest (esterified estrogens; Pfizer) 2.5mg tablets.

Antenatal SSRI Use Linked to Speech/Language Disorders in Offspring

A new study of over 56,000 women found that those who purchased antidepressants at least twice during pregnancy had a 37% increased risk of speech and/or language disorder in their offspring compared to mothers who were not treated with antidepressants.

Birth Control Pills Recalled Due to Reduced Ethinyl Estradiol Levels

Par announced a voluntary recall of certain lots of Gildess, Gildess FE, and Gildess 24 FE products.

Progestin-Containing IUD Appears Safe for Women with Epilepsy

Progestin-containing intrauterine device (IUD) was deemed safe and acceptable as a long-acting contraceptive for women with epilepsy, a study published in Epilepsia has found.

OTC Emergency Contraceptives: Barriers Still Exist

As regulatory status of levonorgestrel emergency contraception has changed over the years, there has been increased confusion about how emergency contraception can be sold.

Preeclampsia Risk Linked to Binding Protein 4 in T1DM

For women with type 1 diabetes, elevated fatty acid binding protein 4 (FABP4) in early pregnancy and in the second trimester is associated with subsequent preeclampsia, according to a study published online September 14 in Diabetes Care.

Investigational Estradiol for Dyspareunia Under FDA Review

The FDA has accepted for review the New Drug Application (NDA) for Yuvvexy (17β-estradiol; TherapeuticsMD) for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women.

New Long-Acting Reversible Contraceptive Approved

Bayer announced that the Food and Drug Administration (FDA) has approved Kyleena (levonorgestrel-releasing intrauterine system) for the prevention of pregnancy for up to 5 years.

Progesterone May Help Prevent Postpartum Smoking Relapse

Data from a pilot randomized trial published in Nicotine & Tobacco Research showed that administering exogenous progesterone may potentially prevent postpartum smoking relapse.

FDA: Clinicians May Be Misled by Ovarian Screening Test Claims

The Food and Drug Administration (FDA) has issued a safety alert regarding the use of screening tests for ovarian cancer screening.

Oral Contraceptives May Be the Main Reason for Ovarian Cancer Drop

Ovarian cancer mortality is down dramatically in many parts of the world, and the use of oral contraceptives (OCs) may be a main reason why, according to a study published online in the Annals of Oncology.

Investigational Postpartum Depression Drug Gets Breakthrough Status

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to SAGE-547 (Sage Therapeutics) for the treatment of postpartum depression (PPD).

CDC: Only Half of Mothers Breastfeed for Recommended Duration

Even though most new mothers in the United States begin breastfeeding their infants at birth, many stop sooner than recommended, according to the 2016 Breastfeeding Report Card from the U.S. Centers for Disease Control and Prevention.

Vaginal Progesterone vs. 17-OHPC for Prevention of Spontaneous Preterm Birth

Daily vaginal progesterone initiated at 16 weeks was a reasonable alternative to weekly 17-alpha-hydroxy-progesterone caproate (17-OHPC) for the prevention of spontaneous preterm birth in women with singleton gestations and prior spontaneous preterm birth, a systematic review in Obstetrics & Gynecology reported.

Does Higher BMI Affect Hormonal Contraceptive Efficacy?

A review published in the Cochrane Database of Systematic Reviews generally found no association between higher body mass index (BMI) or weight and hormonal contraceptive efficacy.

Preterm Infants Can Acquire Monogenic Forms of Diabetes

Monogenic forms of diabetes can occur in preterm infants, according to a study published online in Pediatrics.

Antipsychotics and Congenital Malformations: Is There a Link?

Use of antipsychotics (APs) in pregnancy does not appear to increase the risk for congenital malformations, according to a study published online in JAMA Psychiatry.

No Association Found in Preterm Twin Survival and Antenatal Steroid Use

Antenatal administration of corticosteroids is not associated with a reduction in the incidence of respiratory distress syndrome (RDS) in preterm twins, according to research published in the September issue of Obstetrics & Gynecology.

More Genetic Disorders May Be ID'd With Expanded Carrier Screening

Compared with current recommendations from professional societies, expanded carrier screening may increase the detection of carrier status for potentially serious genetic conditions, according to a study published in the Journal of the American Medical Association.

High Specificity, Low Sensitivity in Onsite Tests for Asymptomatic Bacteriuria

Onsite tests have high specificity for detecting asymptomatic bacteriuria among pregnant women, but sensitivity is lower, according to a review published in the September issue of Obstetrics & Gynecology.

High Levels of Clinical Depression Often Ignored in Infertility Patients

Patients undergoing fertility treatment often suffer symptoms of depression or anxiety, but few get any formal help, according to research published in Fertility and Sterility.

New Guidelines for Diagnosing Fetal Alcohol Spectrum Disorder

An expert panel has proposed clinical guidelines for diagnosing fetal alcohol syndrome disorder (FASD), expanding upon the first guidelines from 2005 that helped distinguish the four subtypes of FASD.

Risk of Vitamin D Drop After Stopping Certain Contraceptives, Study Finds

Researchers from the National Institute of Environmental Health Sciences in Research reported that women risk having their vitamin D levels drop when they cease using contraceptives containing estrogen.

Soy Isoflavones May Benefit Patients with PCOS

Consuming soy isoflavones may improve cardiovascular and metabolic health in women with polycystic ovary syndrome (PCOS), results from a new study in the Journal of Clinical Endocrinology & Metabolism has found.

Study Finds Vaginal Mesh Complications Tied to Proinflammatory Response

Women with vaginal mesh with complications have a significantly increased proinflammatory response, according to a study published in the American Journal of Obstetrics & Gynecology.

Prometrium Capsules Now Available

Virtus has announced the launch of Prometrium (progesterone USP capsule).

CDC Updates Contraceptive Recommendations Relating to Emergency Contraception, IUD Insertion

The Centers for Disease Control and Prevention (CDC) released an update to the 2013 U.S. Selected Practice Recommendations for Contraceptive Use guideline after review of scientific data and expert consultation.

ACOG: Immediate Postpartum LARC Should Be Incorporated into Practice

Obstetrician-gynecologists should counsel pregnant women about use of long-acting reversible contraception (LARC), such as implants and intrauterine devices (IUDs), immediately after they give birth, according to an American College of Obstetricians and Gynecologists (ACOG) Committee Opinion published in Obstetrics & Gynecology.

Novel Wearable Device Detects a Woman's Fertile Days

A bracelet that can track a woman's fertility has been launched today by the medical technology company Ava. In clinical trials the bracelet (which is worn only at night), detected an average of 5.3 fertile days per cycle with 89% accuracy.

Does St. John's Wort Reduce Hormonal Contraceptive Efficacy?

Although evidence is limited, a new systematic review in Contraception indicates a greater risk of ovulation and breakthrough as well as reduced contraceptive efficacy when combined oral contraceptives (COCs) are co-administered with St. John's wort.

Labor Induction and Autism Risk: Is There a Link?

Inducing labor won't raise a pregnant woman's risk of having a child with autism, according to a study published online JAMA Pediatrics.

Guidelines on Sexual Transmission of Zika Updated by CDC

U.S. health officials on Monday updated their Zika virus guidelines, saying that pregnant women could contract Zika from a sex partner of either gender.

Psychotropics and Hormonal Contraceptives: Are Drug Interactions a Cause for Concern?

A new study has deemed that concern for clinically significant drug interactions between hormonal contraceptives (HC) and psychotropic drugs is low; however, the authors of the study did assert that more research is needed in this area.

Nanopause Bolero Available to Relieve Menopause Symptoms

Nanohealth announced the launch of the nanopause Bolero, a non-hormone product cleared by the Food and Drug Administration (FDA) to relieve symptoms of menopause such as hot flashes and night sweats.

Estradiol Effects on Cognition Examined After Menopause

Improvement in cognitive ability is not associated with estrogen therapy among women who use it after menopause, no matter when they start taking it, according to a study published online in Neurology.

No Increased Breast Cancer Risk With IVF Treatment, Study Finds

Women who undergo in vitro fertilization (IVF) are not at increased risk of breast cancer, according to a study published in the issue of the Journal of the American Medical Association.

Does Reducing Caffeine Intake Help Prevent PMS?

Decreasing caffeine intake may not help women prevent premenstrual syndrome (PMS), a team of researchers reported.

PMS, PMDD May Be Comorbidities of Bulimia Nervosa

Premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD) are associated with increased odds of bulimia nervosa (BN), but not with binge-eating disorder (BED), according to a study published in the July issue of the International Journal of Eating Disorders.

Continuation Rates Compared for IUDs, Other Contraceptives

Continuation rates for intrauterine devices (IUDs) were generally higher vs. other contraceptive methods for women aged ≤25 years.

Diagnosis, Management of PCOS Detailed in Newly Published Case Study

The diagnosis and management of polycystic ovary syndrome is discussed in a case vignette published online in The New England Journal of Medicine.

Acne Outcomes Vary Based on Hormonal Contraceptive Used

A patient-reported study of hormonal contraceptives has found a significantly varied effect on acne among commonly prescribed agents.

Breastfed Preemies May Have Healthier Hearts Later in Life

Breastfeeding premature infants appears to increase the likelihood that those infants will have healthier hearts in young adulthood, according to research published online in Pediatrics.

Review: For Women at High Risk of STIs, IUD Does Not Up Risk of PID

Among women with asymptomatic undiagnosed cervical infection or who are at high risk of sexually transmitted infections (STIs), intrauterine device (IUD) placement does not increase the risk of pelvic inflammatory disease (PID) compared with no IUD placement, a study published in Contraception has found.

Risk of Birth Defects with Antiepileptic Drug Combos Examined

New research suggests that the antiepileptic drug (AED) topiramate, when used in combination with other AEDs (excluding valproate) may enhance its propensity to cause fetal malformation.

Positive Results for Potential Bacterial Vaginosis Treatment Announced

Symbiomix announced positive results from the second pivotal Phase 3 trial of SYM-1219 (secnidazole) for the treatment of bacterial vaginosis (BV).

Maternal β-Cells Expansion Tied to Prolactin Receptor Signaling

Prolactin receptor (PRLR) signaling plays a role in expansion of maternal β-cells during pregnancy, according to a study published online in Diabetes.

Prenatal Smoking May Up Schizophrenia Risk in Offspring

In the most definitive study to date, cigarette smoking during pregnancy was linked to a greater likelihood of schizophrenia in offspring. Those are the findings of a new long-term study which assessed maternal nicotine exposure (via cotinine levels) during pregnancy.

Does Too Much Folate During Pregnancy Up Autism Risk?

Researchers from Johns Hopkins Bloomberg School of Public Health reported that too much folate in a new mother's body may increase a child's risk of developing an autism spectrum disorder. Findings from the study will be presented at the 2016 International Meeting for Autism Research.

Are Prophylactic Barbiturates Effective After Perinatal Asphyxia?

An updated Cochrane review found low or very low quality evidence.

Oral Postpartum Hemorrhage Treatment Now Available

Lupin Pharmaceuticals has announced the re-introduction of Methergine (methylergonovine maleate) Oral Tablets 0.2mg for the prevention and management of postpartum hemorrhage (PPH).

FDA Issues Advisory for Antifungal After Reports of Miscarriage Risk

The Food and Drug Administration (FDA) is advising caution when prescribing oral fluconazole (Diflucan) in pregnancy after evaluating data from a Danish study that indicated a possible increased risk of miscarriage when used to treat yeast infections.

Hospira Recalls Magnesium Sulfate Injection

Hospira announced a voluntary recall of one lot of 50% Magnesium Sulfate Injection, 10g/20mL (0.5/gmL), 20mL single-dose vials.

Dietary Supplements for Dysmenorrhea: Are Any Effective?

A Cochrane review found no high quality evidence to support the efficacy of any dietary supplement for dysmenorrhea.

Does Lamotrigine Use in Pregnancy Up Birth Defect Risk?

According to a study published in Neurology, babies born to pregnant women taking lamotrigine may not be at an increased risk of birth defects, such as a cleft lip, cleft palate or clubfoot.

SMFM Statement on Antenatal Corticosteroid Use During Late Preterm Period

The Society for Maternal-Fetal Medicine (SMFM) issued a statement on the use of antenatal corticosteroids during the late preterm birth period for women at risk of preterm birth.

Certain Antidepressants May Up Bone Loss During Lactation

Selective serotonin reuptake inhibitors (SSRIs) use during pregnancy and lactation can result in decreased bone density in mothers, increasing their risk of fractures later in life, a study presented at ENDO 2016 has found.

Risk of Asthma Associated With PCOS, Excess Weight

Polycystic ovary syndrome (PCOS) and excess weight have been independently linked with the onset of asthma, according to findings in a new study to be presented at the annual Endocrine Society meeting.

Radius Submits NDA for New Osteoporosis Tx in Postmenopausal Women

Radius Health announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for abaloparatide-subcutaneous (SC) 80mg, a once daily treatment for postmenopausal women with osteoporosis.

Avoid Compounded Hormone Meds for Menopausal Sx - Endocrine Society

The Endocrine Society has issued a statement advising clinicians to avoid administering compounded hormone medications to treat menopausal symptoms, female sexual dysfunction, and other hormone conditions.

More Exposure to "Sunshine Vitamin" for Mom May Lower Asthma Risk in Kids

Expecting mothers should make sure they get enough vitamin D exposure during the second trimester to reduce the child's likelihood of developing asthma, according to new research by the University of Kansas published in the American Journal of Health Economics.

Flu Vaccinations in Pregnant Women May Protect Against Stillbirths

Researchers from Western Australia reported that seasonal influenza vaccinations may protect against stillbirth.

Not All Migraine Meds Safe for Pregnant Women, Review Finds

Drugs that were once considered safe for pregnant women with migraines may not be, according to researcher at Wake Forest Baptist Medical Center.

Mifeprex Approved for Use Through 70 Days Gestation

The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Mifeprex (mifepristone; Danco Laboratories) including modifications to the risk evaluation and mitigation strategy (REMS) assessment.

Caffeine Consumption May Affect Miscarriage Risk

Researchers from the National Institutes of Health and Ohio State University report that the risk of miscarriage increases if couples consume over two caffeinated beverages a day in the weeks leading up to conception.

Obesity, Oral Contraceptives, and the Risk of Cerebral Venous Thrombosis

In women who use oral contraceptives, obesity is a strong risk factor for cerebral venous thrombosis.

Could a Male Birth Control Pill Soon Be Reality?

Strides are being made toward the development of a male oral contraceptive. Researchers at the University of Minnesota are making tweaks to experimental compounds already developed by the drug company Bristol-Myers Squibb (BMS), to produce a safe, soluble and fast-acting male contraceptive.

Mteryti Prenatal Vitamins Now Available

Duchesnay announced the launch of Mteryti and Mteryti folic 5 products to help optimize iron, calcium, and folic acid absorption for prenatal use.

FDA Orders Follow-Up Studies, Boxed Warning for Essure

In a new draft guidance, the Food and Drug Administration (FDA) announced that they have ordered Bayer to conduct follow-up studies for their permanent form of birth control, Essure.

Study Reveals Surprising Results for Female Libido Pill

How safe and effective is flibanserin (Addyi; Valeant) for the treatment of hypoactive sexual desire disorder (HSDD) in women?

Perimenopausal Symptoms and Treatments: A Review

A new review article explores the current research findings of perimenopausal women's symptoms and the treatment options available to reduce the impact they may have on quality of life.

First Egg-Based DHA Prenatal Vitamins Launched

Vertical Pharmaceuticals announced the launch of OB Complete Gold, prenatal vitamins providing the first egg-based docosahexaenoic acid (DHA).

Atazanavir Exposure in Utero May Have an Effect on Infant Development

Infants whose mothers took atazanavir had small but significant effects on language and social-emotional development, compared to other non-atazanavir-containing antiretroviral regimens, a study published in AIDS has shown.

Study Calls for Evidence-Based Contraception Guidelines for Epileptic Women

A study found that 30% of women with epilepsy did not use highly effective contraception though they are at an increased risk of having babies with fetal malformations due to their antiepileptic medications.

Elagolix Demonstrates Efficacy in 2nd Phase 3 Endometriosis Study

AbbVie and Neurocrine Biosciences announced positive top-line results from the second of two replicate Phase 3 clinical trials of Elagolix in premenopausal women with endometriosis-associated pain.

CDC Updates Interim Zika Virus Guidelines for Pregnant Women and Women of Reproductive Age

Serologic testing for Zika virus has been recommended in asymptomatic pregnant women, who have traveled to, or reside in, areas of ongoing transmission.

Study Finds Compelling Evidence to Change Skin-Prep Practices for C-Section

Authors of a new study argue their findings provide sufficient evidence to change standard skin-prep practices for C-sections, in order to avoid the ongoing risk of infection.

Early Flu Treatment May Reduce Hospital Stay for Pregnant Women

Early treatment with oseltamivir may reduce length of hospital stay for pregnant women with the flu, especially for severe cases, a new study reported.

More 'Evidence-Based' Guidelines Needed for Antidepressant Use During Pregnancy, Say CDC

The U.S. Centers for Disease Control and Prevention (CDC) has called for an increase in research on the potential risks of taking antidepressants during pregnancy.

Prenatal Vitamin D: Can It Reduce Child's Asthma Risk?

Two new trials have found no significant statistical reduction in cases of persistent wheezing and asthma where the mother had taken additional vitamin D supplements.

Asthma Med Use During Pregnancy Linked to Increased Autism Risk

Taking certain asthma medication during pregnancy could increase the risk of the child being diagnosed with autism spectrum disorder.

The Pill Does Not Up Birth Defects Risk, Study Finds

A new study has found that women who take oral contraceptives just before or during pregnancy do not have an increased risk of birth defects.

Increased Risk of Spontaneous Abortion Linked to Oral Antifungal, Study Finds

Using the oral antifungal medication fluconazole during pregnancy has been associated with an increased risk of spontaneous abortion.

Seizure Drug Recalled Due To Potentially Incorrect Barcode

Hospira announced a voluntary recall of one lot of Magnesium Sulfate in Water for Injection (0.235mEq Mg/mL) 40mg/mL 2g total, 50mL due to a potentially incorrect barcode.

Antidepressant May Up Birth Defect Risk if Taken in Early Pregnancy

Using the antidepressant paroxetine during the first trimester of pregnancy may increase the risk of major congenital and cardiac malformations in newborns.

Does Conception via Infertility Txs Increase Likelihood of Developmental Delays?

Children conceived via infertility treatments are no more likely to have a developmental delay than children conceived without such treatments.

Diabetes Drug May Help Prevent, Treat Preeclampsia

Metformin may potentially help prevent and treat preeclampsia, according to a study published in the American Journal of Obstetrics and Gynecology.

Autism Risk Increases With Antidepressant Use During Pregnancy

A large-scale study has found a link between antidepressant (AD) use during the second and/or third trimester of pregnancy and an increased risk of autism spectrum disorder (ASD) in children by 87%.

Smoking During Pregnancy Linked to Lower Fitness Levels in Sons

Young males whose mothers smoked during pregnancy had lower aerobic fitness compared to males whose mothers did not smoke, according to a study published in BJOG: an International Journal of Obstetrics and Gynaecology.

Promising Results in Phase 3 Trial for Novel Estradiol Softgel

A Phase 3 Rejoice Trial of TX-004HR (estradiol) to treat moderate to severe dyspareunia (vaginal pain during sexual intercourse), has had positive top-line results.