Study Finds No Increased Risk of Birth Defects With Birth Control Pill Exposure

Brittany M. Charlton, ScD Instructor Boston Children's Hospital and Harvard Medical School Researcher, Harvard Chan School Department of Epidemiology Boston, MA 02115

Dr. Charlton

MedicalResearch.com Interview with:
Brittany M. Charlton, ScD
Instructor
Boston Children’s Hospital and Harvard Medical School
Researcher, Harvard Chan School Department of Epidemiology
Boston, MA 02115  

Medical Research: What is the background for this study? What are the main findings?

Dr. Charlton: Even though oral contraceptives can be over 99% effective with perfect use, almost 10% of women become pregnant within their first year of use. Many more women will stop using oral contraceptives when planning a pregnancy and conceive within just a few months. In both of those examples, a woman may inadvertently expose her offspring during pregnancy to exogenous sex hormones. We conducted a nationwide cohort study in Denmark in order to investigate whether oral contraceptive use shortly before or during pregnancy was associated with an increased risk of major birth defects in the offspring. Our main finding was that there was no increased risk of having a birth defect associated with oral contraceptive exposure. These results were also consistent when we broke down the birth defects into different subgroups, like limb defects.

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Paroxetine – Paxil – Linked To Increase in Cardiac Birth Defects

Anick Bérard PhD FISPE Research chair FRQ-S on Medications and Pregnancy and Director, Réseau Québécois de recherche sur le médicament (RQRM) and Professor, Research Chair on Medications, Pregnancy and Lactation Faculty of Pharmacy University of Montreal and Director, Research Unit on Medications and Pregnancy Research Center CHU Ste-Justine

Dr. Anick Bérard

MedicalResearch.com Interview with:
Anick Bérard PhD FISPE
Research chair FRQ-S on Medications and Pregnancy
and Director, Réseau Québécois de recherche sur le médicament (RQRM)
and Professor, Research Chair on Medications, Pregnancy and Lactation
Faculty of Pharmacy University of Montreal
and Director, Research Unit on Medications and Pregnancy
Research Center
CHU Ste-Justine 

Medical Research: What is the background for this study? What are the main findings?

Dr. Bérard: Paroxetine (one of the most used antidepressant during pregnancy) has been studied extensively over the past 10-12 years. In 2005, a black box warning was put on the Paxil label to caution against use during pregnancy due to the increased risk of cardiac defects. The ACOG 2010 guidelines also suggested switching to other antidepressants during pregnancy. Over the past decade, many studies, including meta-analyses, were performed on on paroxetine use during pregnancy and the risk of cardiac malformations – but results were sometimes statistically significant or not, although a consistent increased risk was observed. It was thought that these variations could be explained by different study designs, patient populations, and because maternal depression was not always taken into account correctly. Hence, we undertook another meta-analysis (the most recent and updated) to quantify the risk of cardiac defects overall as well as specific cardiac defects associated with paoxetine use during pregnancy and to assess the impact of study designs, maternal depression and patient population on the effect of the risk.

We found that women using paroxetine during the first trimester of pregnancy (critical time-window for malformations) were 23% more at risk of having a child with malformations (15 studies combined) – baseline risk of malformation is 3-5% and thus a 23% increased risk is 3.69-6.15% absolute risk; women using paroxetine during the first trimester of pregnancy were 28% more at risk of having a child with cardiac malformations (18 studies combined) – baseline risk of cardiac malformation is 1% and thus a 28% increased risk is 1.28% absolute risk. We found that paroxetine was increasing the risk of many specific cardiac defects as well. Although the estimates varied depending on the comparator group, study design, and malformation detection period, a trend towards increased risk was observed.

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Large Racial and Ethnic Gaps Exist In US For Premature Births

Edward R. B. McCabe, MD, PhD Senior Vice President and Chief Medical Officer Professor Adjunct of Pediatrics, Yale University School of Medicine Distinguished Professor Emeritus, Department of Pediatrics & Inaugural Mattel Executive Endowed Chair of Pediatrics, UCLA School of Medicine Inaugural Physician-in-Chief, Mattel Children's Hospital UCLA Professor Adjunct of Pediatrics, Yale School of Medicine Chief Medical Officer March of Dimes

Dr. McCabe

MedicalResearch.com Interview with:
Edward R. B. McCabe, MD, PhD
Senior Vice President and Chief Medical Officer
Professor Adjunct of Pediatrics
Yale University School of Medicine
Distinguished Professor Emeritus, Department of Pediatrics & Inaugural Mattel Executive Endowed Chair of Pediatrics, UCLA School of Medicine
Inaugural Physician-in-Chief, Mattel Children’s Hospital
Chief Medical Officer March of Dimes

Medical Research: What is the background for this study? What are the main findings?

Dr. McCabe: The March of Dimes Prematurity Campaign was launched in 2003. The goal of the campaign is to lower the rate of premature birth to 8.1 percent of live births by 2020 and to 5.5 percent by 2030.

Premature birth is the leading cause of death for newborns, and a major cause of childhood disabilities. Worldwide, 15 million babies are born preterm, and nearly one million die due to complications of an early birth. The U.S. preterm birth rate ranks among the worst of high-resource nations. Babies who survive an early birth often face serious and lifelong health problems, including breathing problems, jaundice, vision loss, cerebral palsy and intellectual delays.

The US earned a “C” on the 8th annual March of Dimes Premature Birth Report Card which revealed persistent racial, ethnic and geographic disparities within states. The report card provided preterm rates and grades for each state and the largest cities. The report card showed that although some progress is being made in reducing preterm births, not all families are sharing in the success.

State specific information is available at marchofdimes.org/reportcard

Portland, Oregon has the best preterm birth rate of the top 100 cities with the most births nationwide, while Shreveport, Louisiana has the worst, according to the 2015 Report Card. The U.S. preterm birth rate was 9.6 percent in 2014. The report card shows more than 380,000 babies were born too soon last year.

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No Link Found Between Macrolide Antibiotics and Birth Defects

Anick Bérard PhD FISPE Research chair FRQ-S on Medications and Pregnancy Director, Réseau Québécois de recherche sur le médicament (RQRM) Professor, Research Chair on Medications, Pregnancy and Lactation Faculty of Pharmacy, University of Montreal Director, Research Unit on Medications and Pregnancy Research Center CHU Ste-JustineMedicalResearch.com Interview with:
Anick Bérard PhD FISPE
Research chair FRQ-S on Medications and Pregnancy
Director, Réseau Québécois de recherche sur le médicament (RQRM)
Professor, Research Chair on Medications, Pregnancy and Lactation
Faculty of Pharmacy, University of Montreal
Director, Research Unit on Medications and Pregnancy
Research Center CHU Ste-Justine

Medical Research:  Should we have any reservations about prescribing these macrolides during pregnancy?

Dr. Bérard: With penicillin, macrolides are amongst the most used medications in the general population and in pregnancy. However, debate remained on whether it is the infections or in fact the macrolides used to treat them that put women and their unborn child at greater risk of adverse pregnancy outcomes, including birth defects.
Our study was performed within the Quebec Pregnancy Cohort, one of the largest pregnancy cohorts in the World, and did not find a statistically significant association between macrolide use (a widely used class of antibiotics) during pregnancy and the risk of malformations. When looking at specific types of macrolides, no association was found between azithromycin, clarithromycin or erythromycin use during the first trimester of pregnancy and the risk of major malformations or cardiac malformations. This is reassuring when treating infections during pregnancy.

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CDC Study Finds Variable Risk of Antidepressants During Pregnancy and Birth Defects

Jennita Reefhuis, PhD Epidemiologist with CDC National Center on Birth Defects and Developmental DisabilitiesMedicalResearch.com Interview with:
Jennita Reefhuis, PhD
Epidemiologist with CDC
National Center on Birth Defects and Developmental Disabilities

Medical Research: What is the background for this study?

Dr. Reefhuis: There are previous reports on the link between birth defects and SSRIs. However, the results across some of these studies conflicted. It is not clear whether one SSRI might be safer than other SSRIs.

Medical Research: What are the main findings?

Dr. Reefhuis: Reassuringly, we found that the five earlier reported links between specific birth defects and sertraline were not found again. We did find that some birth defects occur two to three times more frequently among babies born to mothers who took paroxetine and fluoxetine in early pregnancy. Continue reading

Prenatal Exposure To Air Pollutants May Produce Structural Brain Abnormalities

Dr. Bradley S. Peterson, M.D Director of the Institute for the Developing Mind The Saban Research Institute of Children’s Hospital Los Angeles Children’s Hospital Los AngelesMedicalResearch.com Interview with:
Dr. Bradley S. Peterson, M.D
Director of the Institute for the Developing Mind
The Saban Research Institute of Children’s Hospital
Los Angeles Children’s Hospital Los Angeles

Medical Research: What is the background for this study?

Dr. Peterson: Neurotoxic PAH (polycyclic aromatic hydrocarbons) are ubiquitous in the environment, in the home and in the workplace. Emissions from motor vehicles, oil and coal burning for home heating or power generation, wildfires and agricultural burning, hazardous waste sites, tobacco smoke and charred foods are all sources of exposure. PAH readily crosses the placenta and affects an unborn child’s brain; earlier animal studies showed that prenatal exposure impaired the development of behavior, learning and memory. Our group previously reported that exposure to airborne PAH during gestation was associated with multiple neurodevelopmental disturbances, including development delay by age 3, reduced verbal IQ at age 5, and symptoms of anxiety and depression at age 7.

Medical Research: What are the main findings?

Dr. Peterson: Together with Virginia Rauh, ScD and Frederica Perera, DrPH, PhD of Columbia University’s Mailman School of Public Health, we conducted a brain imaging study to test the effects on brain structure of PAH exposure during the final trimester of pregnancy.  We used magnetic resonance imaging (MRI) to measure the brains of 40 children from a cohort of more than 600 mother-baby pairs from minority communities in New York City. These 40 children were carefully selected to have no other exposures that would affect brain development. Our findings showed that prenatal PAH exposure led to reductions in nearly the entire white matter surface of the brain’s left hemisphere – losses that were associated with slower processing of information during intelligence testing and more severe behavioral problems, including ADHD and aggression.  Postnatal PAH exposure – measured at age 5 – was found to contribute to additional disturbances in development of white matter in the dorsal prefrontal region of the brain, a portion of the brain that supports concentration, reasoning, judgment, and problem-solving ability. Continue reading

High DNA Mutation Rate In Teenage Dads May Lead To More Birth Defects

Dr. Peter Forster PhD Fellow of Murray Edwards College and McDonald Institute at the University of CambridgeMedicalResearch.com Interview with:
Dr. Peter Forster PhD
Fellow of Murray Edwards College and
McDonald Institute at the University of Cambridge

 

Medical Research: What is the background for this study? What are the main findings?

 

Dr. Forster: As a result of our paternity testing work at the Institute for Forensic Genetics in Munster (Germany), we have accumulated a pool of over 24,000
parents and their children, of whom we know for certain that they are
biologically related. Occasionally we observe a new mutation in these
children, which must have come either from the sperm or the egg of one
of the parents. As we analyse highly variable microsatellite DNA (a
repetitive type of DNA, also know as STR DNA, which stands for “short
tandem repeat” DNA), we can fairly easily find out whether the mutation
has come from the mother or the father. It turns out that the fathers
contribute 6-7 times more mutations to the children than the mothers do.
This has long been known. What is new is that we have observed that the
male and female teenagers at puberty do NOT set out with the same low
mutation load, but instead, the teenage boys already have a sixfold
higher mutation load in their sperm than the girls in their oocytes. Continue reading

For Most Birth Defects Survival Poorer Among Minorities

MedicalResearch.com Interview with:
Ying Wang, PhD, MPH

Data Management, Analysis & Research
Office of Primary Care and Health System Management
New York State Department of Health
Empire State Plaza  Albany, NY  12237

Medical Research: What is the background for this study? What are the main findings?

Dr. Wang: The purpose of the study was to examine the survival of children with one or more of 21 major birth defects in the United States.  We used data from 12 population-based birth defects surveillance programs that participate in the National Birth Defects Prevention Network.  The study included nearly 100,000 infants born with birth defects between 1997 and 2007.

We found that children who were born with hypoplastic left heart syndrome (a severe congenital heart defect) had the lowest chance of survival across multiple ages (up to 28 days of life, 1 year, 2 years, and 8 years of life), compared to children with any other birth defects studied.  We also found that the chances of survival up to 1 year of life was greater than 90% for babies born with spina bifida, cleft palate, cleft lip with or without cleft palate, pyloric stenosis, gastroschisis, or Down syndrome. For most birth defects, survival was poorer among non-Hispanic black mothers and Hispanic mothers compared to non-Hispanic white mothers.
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More Women Of Reproductive Age Need Folic Acid To Prevent Birth Defects

Jennifer Williams MSN, MPH, FNP-BC National Center on Birth Defects and Developmental Disabilities CDC, Atlanta, Georgia MedicalResearch.com Interview with:
Jennifer Williams MSN, MPH, FNP-BC

National Center on Birth Defects and Developmental Disabilities
CDC, Atlanta, Georgia

Medical Research: What is the background for this study? What are the main findings?

Response: Neural tube defects are serious birth defects of the brain and spine that can cause significant disability and death. Studies have shown that taking 400 mcg of folic acid daily before and during pregnancy can reduce the prevalence of neural tube defects. Therefore, in 1992, the US Public Health Service (USPHS) recommended that all women of childbearing age in the United States who are capable of becoming pregnant consume 400mcg of folic acid per day to reduce the risk of neural tube defects. To help women meet this requirement, in 1998 the US Food and Drug Administration (FDA) mandated that folic acid be added to enriched grain products for the prevention of neural tube defects.

This study looks at how many neural tube defects have been prevented annually since folic acid fortification. Using data from birth defects tracking systems, researchers found that since folic acid fortification, the birth prevalence of neural tube defects has decreased by 35% in the United States, which translates to about 1,300 babies that are born each year without a neural tube defect who might otherwise have been affected.  This study also reports that the number of babies born with a neural tube defect annually differs by the mother’s race/ethnicity. Hispanic mothers continue to be at the highest risk for having a baby with a neural tube defect.

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Maternal Obesity Increases Congenital Kidney/Urinary Anomalies in Offspring

MedicalResearch.com Interview with:
Ian R. Macumber MD
Pediatric Nephrology, Seattle Children’s Hospital
Seattle, Washington

Medical Research: What are the main findings of the study?

Dr. Macumber: The main finding is that there is a strong association between maternal obesity and odds of congenital anomalies of the kidney and urinary tract (CAKUT) in offspring.  This relationship remains strong when looking at offspring with renal malformation (excluding non-renal congenital anomalies of the kidney and urinary tract), or in offspring with isolated congenital anomalies of the kidney and urinary tract (no congenital anomalies elsewhere in the body).  There is a dose-response relationship to this association, with the offspring of extremely obese mothers have even higher odds of having congenital anomalies of the kidney and urinary tract.

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Do Antidepressants During Pregnancy Promote Cardiac Birth Defects?

Dr. Krista Huybrechts MD PhD Brigham & Women’s Hospital Department of Medicine Division of Pharmacoepidemiology & Pharmacoeconomics Boston, MA 02120MedicalResearch.com Interview Invitation
Dr. Krista Huybrechts MD PhD
Brigham & Women’s Hospital
Department of Medicine
Division of Pharmacoepidemiology & Pharmacoeconomics
Boston, MA 02120

MedicalResearch: What are the main findings of the study?

Dr. Huybrechts: In this cohort study including 949,504 pregnant women enrolled in Medicaid, we examined whether the use of selective serotonin reuptake inhibitors (SSRIs) and other antidepressants during the first trimester of pregnancy is associated with increased risks for congenital cardiac defects. In order to control for potential confounding by depression and associated factors, we restricted the cohort to women with a depression diagnosis and used propensity score adjustment to control for depression severity and other potential confounders. We found no substantial increased risk of cardiac malformations attributable to SSRIs. Relative risks for any cardiac defect were 1.25 (95%CI, 1.13-1.38) unadjusted, 1.12 (1.00-1.26) depression-restricted, and 1.06 (0.93-1.22) depression-restricted and fully-adjusted. We found no significant associations between the use of paroxetine and right ventricular outflow tract obstruction (1.07, 0.59-1.93), or the use of sertraline and ventricular septal defects (1.04, 0.76-1.41); two potential associations that had been of particular concern based on previous research findings.
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Many Pregnant Women Have Not Taken Folic Acid to Reduce Neural Tube Defects

Prof. Nicholas J. Wald Wolfson Institute of Preventive Medicine Barts and the London School of Medicine and Dentistry Queen Mary University of London London, United KingdomMedicalResearch.com Interview with:
Prof. Nicholas J. Wald
Wolfson Institute of Preventive Medicine
Barts and the London School of Medicine and Dentistry
Queen Mary University of London
London, United Kingdom

MedicalResearch.com: What are the main findings of the study?

Prof Wald: The percentage of women who become pregnant without having taken folic acid supplements to reduce the risk of a neural tube defect declined from a relatively low proportion (35%) to an even lower one (31%) between 1999 and 2012.

Moreover such use of folic acid in some groups of the population is much lower for example 17% in Afro-Caribbean women and 6% in women aged under 20.
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Pregnancy: Birth Defects Risks with Oral Fluconazole

MedicalResearch.com Interview with:
Ms. Mølgaard-Nielsen

Statens Serum Institut
Artillerivej 5, 2300
Copenhagen S, Denmark

MedicalResearch.com: What are the main findings of the study?

Answer: Use of oral fluconazole during early pregnancy did not increase the risk of birth defects overall in common therapeutic doses. We also looked at 15 individual birth defects of previous concern and oral fluconazole was not associated with an increased risk for 14 of these birth defects.  However, we did see an increase in the risk of tetralogy of Fallot, an uncommon congenital heart defect, but the number of exposed cases was few.
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