Antidepressants, SSRI birth defect risks
Depression… it hurts. How many times have you heard that on TV? For women like you wanting to get pregnant, depression and taking antidepressants might hurt your unborn baby.
Did your healthcare profession share that fact with you? Decisions for how to treat depression in pregnant women have become increasingly complex. Patients and their doctors must carefully weigh and discuss potential benefits and risks of treatment with antidepressants during pregnancy. Some new studies provide important information to be considered in making such decisions.
The studies included women who had been treated with antidepressant drugs that act as selective serotonin reuptake inhibitors (SSRIs) or, in a few cases, other antidepressants. SSRI medications are the most commonly used drugs to treat depression in the United States.
One study by the Journal of American Medical Association involved stopping the antidepressant while pregnant. This solution was not a good one because women became more depressed and were five times as likely to relapse into a worsen depression than previously.
A second study also published by the Journal of American Medical Association suggested there could be rare risks from SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth of the newborn.
Every drug label in this SSRI/antidepressant section more or less has the same problem… a warning whether it’s the first trimester or the third trimester. When treating pregnant women with a particular SSRI antidepressant brand, the physician should carefully consider the potential risks and potential benefits of treatment.
Rare Abdominal Wall Birth Defect: Omphalocele
According to the Centers for Disease Control and Prevention (CDC) about 775 babies in the United States are born with an omphalocele per year.
What is this rare and hard to pronounce (om’fal-o-sel) abdominal wall birth defect?Omphalocele is a congenital defect in the abdominal wall in which erratic amounts of abdominal contents protrude into the base of the umbilical cord. Until about week 10 of pregnancy, it is normal for the bowel to be outside of the baby’s belly. After 10 weeks the bowel should be inside the belly.
Omphalocele occurs when the bowel, liver, and sometimes other organs remain outside the belly in a sac.
What may cause omphalocele?
- Women who were prescribed selective serotonin-reuptake inhibitors (SSRIs) during pregnancy were more likely to have a baby with an omphalocele. Some brands of SSRIs include Paxil, Prozac, Zoloft, Lexapro, Celexa, Asentra.
- Women who consume alcohol or are heavy smokers such as more than one pack a day are more likely to have a baby with omphalocele.
- Women who are obese or overweight before pregnancy were more likely to have a baby with omphalocele.
Rare Skull Birth Defect Lawsuit – Craniosynostosis
Craniosynostosis affects one in 2,000 to 2,500 live births worldwide. This sounds like a rare skull birth defect but if your baby is that one – Monheit Law can help.
What is this rare skull birth defect?Craniosynostosis is premature fusion of the skull bones. While some children are born with this skull birth defect, other children later develop it. When there’s not enough space for the growing brain, intracranial pressure leads to loss of visual and mental impairment.
The skull is comprised of different bones that fit together like a jigsaw puzzle. The areas where the bones meet are called sutures. Bones normally expand and grow. When that doesn’t happen, the condition is called craniosynostosis which leads to an abnormally shaped skull.
What causes craniosynostosis?
Prescription drugs that disrupt the development of the fetus or embryo may cause this rare skull birth defect. Medication like antidepressants or other prescription or over-the-counter drugs that cross the placenta may disturb fetus or embryo development.
More causes may include:
- Smoking during
- High levels of thyroid hormone
- Fetal head constraint during pregnancy
Currently, surgery is the only effective treatment for craniosynostosis. The planning and timing of the surgery is important as to the success of this treatment.
Neural Tube Defects and Antidepressants, SSRI Drugs, NTDs
Millions of women take antidepressants like Prozac, Paxil, Celexa, Lexapro, Zoloft, and Symbyax. Thousands of newborns suffer from birth defects. Is there a connection?
SSRI drugs or antidepressants cross the placenta which may have adverse side effects on the newborn.
What are neural tube defects or NTDs? An NTD is an opening in the spinal cord or brain that early on affects the fetus, sometimes so soon that a woman has no clue that she is even pregnant yet. In the United States, neural tube defects are fairly common with an estimated one in every one thousand live births.
Two types of neural tube defects exist. Defects that are open like spina bifida and anencephaly are more common than closed neural tube defects. Open neural tube defects mean the brain and/or spinal cord is exposed at birth through a defect in the skull or back bone.
Spina bifida is the most common neural tube defect. Complications include water on the brain where fluid accumulates in the brain, enlarging the head and sometimes causes brain damage, gastrointestinal disorders, urinary and bowel dysfunction, obesity, depression, tendonitis, and tendency towards latex allergies.
The cause or causes of neural tube defects are not readily known. Some causes are genetic, environmental, and nutritional or folic acid deficiencies. Seizure medication has been associated with an increased risk as well as maternal diabetes, radiation exposure, and smoking cigarettes.
Women taking antidepressants may be yet another cause for neural tube defects like spina bifida.
Heart Birth Defect Lawsuit: PPHN, Pulmonary Stenosis, Coartation of the Aorta
Life, it’s precious and ever so more precious when it’s your baby and your baby suffers from a heart birth defect.
Why me? Mothers of babies who suffer heart birth defects must not blame themselves. Studies are finding that as more women of child-bearing age take antidepressants like Prozac, Zoloft, Paxil, Symbyax, Celexa, Lexapro, and Effexor—more babies are born with heart birth defects. Is there a relationship between the two?
What are some heart birth defects?
—PPHN / persistent pulmonary hypertension of the newborn
PPHN is a life-threatening disorder in which the newborn’s arteries to the lungs remain constricted after delivery, limiting the amount of blood flow to the lungs and therefore the amount of oxygen into the bloodstream.
SSRIs brands that affect PPHN include Celexa, Lexapro, Paxil, Prozac, Symbyax, and Zoloft.
In recently published New England Journal of Medicine study, infants born to mothers who took SSRIs after the 20th week of pregnancy were six times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy. The background risk of a woman giving birth to an infant affected by PPHN in the general population is estimated to be about 1 to 2 infants per 1,000 live births.
—Pulmonary valve stenosis
Another congenital heart defect, pulmonary valve stenosis, is a fixed obstruction of flow from the right ventricle of the heart to the pulmonary artery and is initially diagnosed in childhood. If severe, babies may turn blue.
The pulmonary valve can be treated to improve the obstruction and leak, but the valve won’t be made normal. Treatment is needed when the pressure in the right ventricle is great (even if there are no symptoms). The obstruction can usually be relieved during cardiac catheterization by balloon valvuloplasty. A catheter containing a balloon is placed across the pulmonary valve. The balloon is inflated for a short time to stretch open the valve.
—Coarctation of the aorta
When an infant is born with coarctation of the aorta, he or she is born with an abnormally narrow aorta. The narrowing causes abnormal blood flow and a decrease in blood flow to the lower part of the body. Aortic coarctation can be a life-threatening congenital defect if left untreated.
Septal Congenital Heart Defects, Paxil Antidepressant
Millions of women take antidepressants like Paxil. While Paxil may aid with depression, Paxil may also increase the risks of septal congenital heart defects in newborns.
At the FDA’s request, GlaxoSmithKline, drug maker of Paxil, altered Paxil’s pregnancy category from C to D and added new data and recommendations to the “Warnings” section of the prescribing information.
Observed in studies, most of the heart defects were atrial septal defects (ASD) or ventricular septal defects (VSD), conditions in which the wall between the right and left sides of the heart is not completely developed.
Atrial septal defect is a congenital heart defect which enables blood flow between the left and right atria via the interatrial septum.
Fortunately, many atrial septal defects close without treatment during childhood or any intervention. But for the atrial septal defects that don’t close, many do eventually require surgery to be corrected.
A ventricular septal defect is usually symptom-free at birth, but becomes known or discernible a few weeks after birth. This condition is associated with other congenital conditions like Down syndrome.
A large ventricular septal defect that is large will require surgery to close the defect. Newborns will likely have the surgery within the first year of life.
Wellbutrin, another popular antidepressant, has been linked to heart-related birth defects too for women who took the drug one month prior to getting pregnant and during the first trimester of pregnancy.
Cardiac malformations of Paxil-exposed infants were primarily ventricular septal defects (VSD) and atrial septal defects (ASD). Septal defects range in severity from resolving spontaneously to requiring surgery.A separate retrospective U.S. study evaluated 5,956 infants of mothers who took antidepressants during the first trimester. This study showed a trend towards an increased risk for cardiovascular malformations from Paxil compared to other antidepressants. Of the dozen Paxil-exposed infants with heart malformations, nine infants had ventricular septal defects. This study also suggested an increased risk of overall major congenital malformations including heart defects for Paxil compared to other antidepressants.
According to the Lexapro labeling: Pregnancy-Nonteratogenic Effects provides information regarding complications developed by neonates exposed to Lexapro and other SSRIs or SNRIs (serotonin and norepinephrine reuptake inhibitors), late in the 3rd trimester.Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn or PPHN.When treating a pregnant woman with Lexapro during the 3rd trimester, consider potential risks and benefits. Labeling describes a prospective longitudinal study in which women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression.
Neonates exposed to Celexa and other SSRIs late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery.Reported clinical findings have included respiratory distress, cyanosis (turning blue), apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia (low muscle tone), hypertonia (hyper muscle tone), hyperreflexia (twitching), tremor, jitteriness, irritability, and constant crying. These features are consistent with a direct toxic effect of SSRIs and possibly a drug discontinuation syndrome.
As of August 2011, the FDA prepared an alert for anyone including mothers who are taking Celexa. Higher doses of Celexa (40 mg) can lead to an abnormal heart rhythm which can be fatal. Patients at particular risk for developing this condition include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood.
Infants exposed to SSRI antidepressants like Prozac in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN) which occurs in 1 to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality.More than 10 cohort studies and case-control studies failed to demonstrate an increased risk for congenital malformations overall.
One prospective cohort study conducted by the European Network of Teratology Information Services reported an increased risk of cardiovascular malformations in infants born to women taking Prozac during their first trimester. Apparently this has not caused enough concern for the FDA to make specific recommendations.
Neonates exposed to Prozac and other SSR antidepressants late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery.
Zoloft may be linked to the following birth defects:
- Heart defects
- Cleft lip and cleft palate
- Neural tube defects like spina bifida
- PPHN – Persistent Pulmonary Hypertension of the Newborn
- Limb defects
- Skull defects – craniosynostosis
Zoloft is in the Pregnancy Category C: Studies were conducted on animals like rats. But how does that related to you, to women, to their unborn babies? Fortunately, studies are not ethically allowed to be performed on pregnant women.
Like other antidepressants, Zoloft should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In a retrospective case-control study of 377 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy.
Symbyax is somewhat different than the above antidepressants. Symbyax combines two psychotropic drugs – olanzapine and fluoxetine – better known Zyprexa and the antidepressant or SSRI, Prozac. Symbyax still is considered a SSRI drug.Women should notify their doctor if they become pregnant or intend to become pregnant during Symbyax therapy.Symbyax may be associated with birth defects, specifically, congenital heart defects, Persistent Pulmonary Hypertension of the Newborn (PPHN), abdominal defects, and cranial defects.
Women who breast-feed should not do so while taking Symbyax.
Symbyax is in the drug pregnancy category C meaning that in studies with animals, there were fetal problems. As with most drugs there are no well-controlled Symbyax studies for pregnant women because that would be unethical.
Symbyax should be used during pregnancy only if potential benefits justify potential risks to the fetus.