Search results for: malm

Titled “Infant and childhood neurodevelopmental outcomes following prenatal exposure to selective serotonin reuptake inhibitors: overview and design of a Finnish Register-Based Study (FinESSI).”, an article by a team of prominent SSRI-birth defect researchers led by H. Malm (2012) published in BMC Psychiatry makes great strides in elucidating the range of adverse effects of prenatal exposure to selective serotonin reuptake inhibitor drugs (SSRIs).

Malm et al. (2012) write “Experimental animal studies and one population-based study have suggested an increased risk for adverse neurodevelopmental outcome after prenatal exposure to SSRIs. We describe the methods and design of a population-based study examining the association between prenatal SSRI exposure and neurodevelopment until age 14.”

Using nationalized birth registers from Finland, the study included “845,345 women and their live-born, singleton offspring aged 14 or younger and born during Jan 1st 1996-Dec 31st 2010.”  The team states, “We will compare the prevalence of psychiatric and neurodevelopmental outcomes in offspring exposed prenatally to SSRIs to offspring exposed to prenatal depression and unexposed to SSRIs.”

Results showed that “Of all pregnant women with pregnancy ending in delivery (n=859,359), 1.9% used SSRIs. The prevalence of diagnosed depression and depression-related psychiatric disorders within one year before or during pregnancy was 1.7%. The cumulative incidence of registered psychiatric or neurodevelopmental disorders was 6.9% in 2010 among all offspring born during the study period (age range 0-14 years).”

As such, they concluded that “The study has the potential for significant public health importance in providing information on prenatal exposure to SSRIs and long-term neurodevelopment.”

If you or a loved one use SSRIs while pregnant and your child was born with a birth defect, your family may be entitled to significant financial compensation through an SSRI birth defect lawsuit.  For a free, no-obligation case consultation, contact our team of SSRI birth defect lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.

Recently, while researching the connection between maternal use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy and birth defects, I came across this letter to the editor of The American Journal of Psychiatry.  Titled “Should Paroxetine Be Used to Treat Depression During Pregnancy?”, published November 2008, authors Barbara Mintzes and Jon Jureidini suggest that though some studies on the safety of SSRIs for developing babies present conflicting evidence, shouldn’t we err on the side of caution?

Here is the complete letter:

“To the Editor: In the June 2008 issue of the Journal, Adrienne Einarson, R.N. et al. (1) concluded that the existing evidence does not suggest an association between the use of paroxetine during pregnancy and congenital cardiovascular defects. Their conclusion was based on an observational study and five previous cohort studies. The authors stressed the need to treat depression during pregnancy and stated that if appropriate treatment includes paroxetine, the findings of their study “should reassure women and their health care providers” (1, p. 752). This endorsement is at odds with regulatory warnings (2).

The design and reporting of the study raise questions pertaining to claimed results. No data are provided regarding 1) baseline characteristics of exposed women and unexposed comparison women, 2) whether the analysis is intention-to-treat or per protocol, 3) loss to follow-up, or 4) proportion with evaluable outcomes. Both the exposure levels and procedures to select comparison women were unclear. Additionally, the outcome assessment was not blinded to exposure, and treatment for ambiguous diagnoses was unclear.

Einarson et al. included a secondary analysis of five cohort studies of paroxetine exposure during pregnancy. Although four of these studies included comparison groups and two reported significant increases in congenital malformation rates among exposed women (3, 4), these data were omitted. The authors reported a subset of available observational studies, and the selection criteria were unclear.

If harm from paroxetine use during pregnancy cannot be excluded based on the evidence provided, can benefit be assumed? To our knowledge, no randomized controlled trial has examined whether paroxetine treats depression during pregnancy more effectively than placebo, psychotherapy, or alternative treatment/therapy. Einarson et al. stated that randomized controlled trials cannot be conducted “for obvious reasons” (1, p. 751). We question the assumption that treatments should be offered to pregnant women with less evidence of benefit than those treatments offered to nonpregnant women. More, not less, caution is needed to ensure that potential benefit outweighs potential harm.

The authors also cited a study published in the Journal of the American Medical Association (JAMA) (5) reporting high rates of depression relapse after discontinuation of paroxetine during pregnancy. The study was not randomized, neither patients nor treating doctors were blinded, and patients were briefed about the “risk of depressive relapse associated with discontinuation of antidepressant therapy.” Additionally, no attempts to distinguish relapse from drug discontinuation syndrome were described.

Neither the safety nor effectiveness of paroxetine treatment during pregnancy has been established. Since studies conducted in a range of settings have indicated potential harm, should we not adopt a cautious approach to further exposure, rather than requiring certainty about harm?

1.Einarson A, Pistelli A, DeSantis M, Malm H, Paulus WD, Panchaud A, Kennedy D, Einarson TR, Koren G: Evaluation of the risk of congenital cardiovascular defects associated with the use of paroxetine in pregnancy. Am J Psychiatry 2008; 165: 749–752

2.US Food and Drug Administration: FDA Advising of Risk of Birth Defects With Paxil, P05-97. Rockville, Md, FDA News, 2005. http://69.20.19.211/bbs/topics/NEWS/2005/NEW01270

3.Kallen BA, Olausson P: Maternal use of selective serotonin re-uptake inhibitors in early pregnancy and infant congenital malformations. Birth Defects Res A Clin Mol Teratol 2007; 79:301–308

4.GlaxoSmithKline: Epidemiology Study: Paroxetine in the First Trimester and the Prevalence of Congenital Malformations, EPI40404. http://ctr.gsk.co.uk/Summary/paroxetine/studylist.asp

5.Cohen LS, Altshuler LL, Harlow BL, Nonacs R, Newport DJ, Viguera AC, Suri R, Burt VK, Hendrick V, Reminick AM, Loughead A, Vitonis AF, Stowe ZN: Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA 2006; 295: 499–507”

Since many people have used SSRI drugs aware of the risks associated with their use during pregnancy, many SSRI birth defect lawsuits are currently being filed.  If you or a loved one used SSRIs and gave birth to a child with a congenital malformation or who had perinatal complications, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of SSRI birth defect lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.

Over the past several decades, a number of studies have linked selective serotonin reuptake inhibitors (SSRIs) to a range of birth defects: neurological birth defects including spina bifida, cardiovascular birth defects including tricuspid atresia, craniofacial defects like cleft palate, developmental disorders such as autism, and neonatal adaptation disorders.  As the manufacturers of many SSRIs have failed to notify expecting mothers of these risks, a number of SSRI birth defect lawsuits have been filed.

Here, I present another mention of this connection, published in a 2010 edition of Reproductive Toxicology by M. Effolk and H. Malm of Helsinki University Central Hospital (Finland).  Their article is titled “Risks associated with in utero and lactation exposure to selective serotonin reuptake inhibitors (SSRIs).”

The team states “Prenatal exposure to selective serotonin reuptake inhibitors (SSRIs) may increase risk for congenital malformations and adverse perinatal outcome” and performed a literature review.

Results showed that “paroxetine and possibly fluoxetine use in early pregnancy may be associated with a small increased risk for cardiovascular malformations. Perinatal adverse effects, including respiratory distress and neonatal adaptation problems are common in exposed infants, and an increased risk for persistent pulmonary hypertension of the newborn (PPHN) has been observed.”  These findings are largely in line with other similar research.  To see more studies linking SSRIs and birth defects, follow the preceding link.

If you or a loved one used SSRIs and had a child who was born with a congenital malformation, developmental disorder, or who had a poor neonatal adaptation, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of SSRI birth defects lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.

Published in the December, 2012 edition of Therapeutic Drug Monitoring, an article by H. Malm titled “Prenatal exposure to selective serotonin reuptake inhibitors and infant outcome.”  provides further insight into the connection between prenatal exposure to selective serotonin reuptake inhibitor (SSRI) drugs and adverse birth outcomes.  Malm has done a great deal of research on these drugs in years past, demonstrating that a number of birth defects are linked to neonatal SSRI exposure.  For more research by this scientist, follow this link.

SSRIs are a class of psychiatric medications that work to regulate mood by regulating the concentration of serotonin molecules between neurons in the brain.  However, studies have shown that serotonin plays an important role not only in mood regulation, but also in sleep and appetite regulation, and neonatal development.

For the above-referenced study, Malm performed a literature review, analyzing previously-conducted research.  The author writes “Fluoxetine and paroxetine use in early pregnancy has been associated with a small increased risk for specific cardiovascular malformations in some studies, fluoxetine with ventricular septal defects and paroxetine with right ventricular outflow tract defects.”

To be clear, “fluoxetine” is the chemical name for Prozac, and “paroxetine” is the chemical name for Paxil.

Malm continues: “Respiratory distress and neonatal adaptation problems are common in prenatally exposed infants, and an increased risk for persistent pulmonary hypertension of the newborn has been observed in several studies. Although several studies have not confirmed an increased risk for adverse neurodevelopment, a recent study observed an increased risk for autism spectrum disorders in prenatally exposed offspring.”

Importantly, the author also cautions that a correlation between two variables does not imply that one causes the other: “Causality cannot be confirmed in observational study settings. However, parallel results in individual studies regarding the cardiac malformations and pulmonary hypertension of the newborn, together with an existing biologically plausible mechanism behind these events may support causality. Considering the important role of serotonin in central nervous system development, more studies are needed to assess the possible adverse effects on long-term neurodevelopment.”

Unfortunately, the companies who manufacture these drugs have failed time and again to adequately inform patients of the risk for bearing children with birth defects or developmental disorders.  As a result, a number of Prozac lawsuits and Paxil lawsuits have been filed.

If you or a loved one used Prozac, Paxil, or another SSRI and gave birth to a child with a congenital malformation, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Prozac® birth defects lawyers and Paxil® birth defects lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.

The objective of a study titled “Risks Associated with Selective Serotonin Reuptake Inhibitors in Pregnancy”, done by researchers from the Teratology Information Service, HUSLAB, at Helsinki University Central Hospital in Finland, was to determine the effects of selective serotonin reuptake inhibitors (SSRIs) on pregnancy outcomes; and implicitly, to determine the likelihood that children whose mothers used SSRI drugs during pregnancy with be born with birth defects.

In the past, research has shown that selective serotonin reuptake inhibitors contain chemicals that may increase the risk of major congenital malformations in offspring exposed during early development, and SSRIs have long been known to have certain fetus-damaging capabilities.  This study was population based study of 1,782 women who had taken an SSRI during pregnancy.   A national project done in Finland was used to link information from the Drug Reimbursement Register, The Medical Birth Register, the Register of Congenital Malformations, and the Register of Induced Abortions to obtain information for this project.  Malm states “Comparisons were made between women with SSRI purchases to matched controls and between women with purchases in different trimesters. Only singleton pregnancies were included. Primary outcomes were major malformations, preterm birth, small for gestational age, low birth weight, and treatment in neonatal special or intensive care unit. Analyses were based on logistic models.”

Results show that major malformations were not more common in infants of women who took an SSRI during the first trimester of pregnancy, when compared with the control group of mothers who were not exposed to an SSRI during any part of their pregnancy.  Over 15 percent of infants who were exposed to SSRIs during the 3rd trimester of pregnancy were treated  in special or intensive care units.  This was slightly higher than infants exposed only during the 1st trimester, which was 11.2 percent.

Malm further explains “We found no increased risk of preterm birth (< 37 weeks), birth 32 weeks of gestation or less, small for gestational age, or low birth weight in women with purchases in each trimester or during the 2nd and 3rd trimesters when compared with women with only 1st trimester purchases.”  There was not a clear connection made between the use of SSRIs during pregnancy with an increased risk of adverse perinatal outcome.

This article and ones like it could be used in an SSRI birth defects lawsuit (e.g. Paxil lawsuit, Prozac lawsuit, Effexor lawsuit, Celexa lawsuit, Zoloft lawsuit, or others) to demonstrate to a court that the manufacturers of these drugs knew or should have known the risks for birth defects associated with SSRIs.

If you or a loved one used SSRIs during pregnancy and your child was born with a congenital malformation, you may be eligible to file an SSRI birth defect lawsuit seeking compensation for the undue injury caused to your child.  For more information on SSRI birth defects or a free, no-obligation case consultation, please do not hesitate to contact our team of SSRI birth defects lawyers at the information provided below.

(855) 452-5529

justinian@dangerousdrugs.us

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.

Anencephaly is a terrible congenital malformation (present at birth) characterized by the lack of development or absence of a large part of the brain or skull.  Sadly, babies with anencephaly most often die within the first hours or days of life.

A type of neural tube defect, PubMed Health – a service of the U.S. National Library of Medicine – explains anencephaly as follows: “Anencephaly occurs early in the development of an unborn baby. It results when the upper part of the neural tube fails to close. Why this happens is not known. Possible causes include environmental toxins and low intake of folic acid by the mother during pregnancy.

Anencephaly occurs in about 1 out of 10,000 births. The exact number is unknown, because many of these pregnancies result in miscarriage. Having one infant with this condition increases the risk of having another child with neural tube defects.”[1]

Symptoms of anencephaly include “Absence of the skull, absence of the brain (cerebral hemispheres and cerebellum), facial feature abnormalities, [and] heart defects.”[2]  Unfortunately, there is no known cure or treatment for anencephaly.[3]

 

Anencephaly Linked to Maternal SSRI Use

Recently, a study published by Heli Malm et al in Obstetrics and Gynecology has demonstrated that babies born to mothers who had used SSRIs during pregnancy (especially Celexa® — citalopram) were 2.46 times as likely to be born with neural tube defects such as anencephaly, spina bifida, and encephalocele.[4]

While other studies confirming these findings will likely soon be published, a connection between SSRI use an anencephaly stark as this may be used in a SSRI birth defect lawsuit to help provide convincing evidence that the manufacturer of Celexa® and other SSRIs knew, or should have known of the dangers of one of its products, and failed to make the appropriate warnings.

If you used Celexa during pregnancy and your child was born with anencephaly or another congenital malformation, please do not hesitate to contact our team of Celexa birth defects lawyers for a free, no-obligation case consultation.  At your convenience, you may reach us by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.

[1] “Anencephaly – PubMed Health” PubMed Health. U.S. National Library of Medicine. © 2012 A.D.A.M., Inc. Available at <http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002547/> Accessed 5 February 2013

[2] Ibid.

[3] Ibid.

[4] Malm, H., et al. (2011) “Selective Serotonin Reuptake Inhibitors and Risk for Major Congenital Anomalies” Obstet Gynecol Vol. 118, No. 1; p. 111-120

Spina Bifida (“myelomeningocele” being the most common form) is a birth defect in the larger class of “neural tube defects,” characterized by the malformation or underdevelopment of the neural tube in a developing infant before birth.  In spina bifida, “the backbone and spinal canal do not close before birth”[1] as they normally would.

PubMed Health, a service of the United States National Library of Medicine, states “Normally, during the first month of a pregnancy, the two sides of the spine (or backbone) join together to cover the spinal cord, spinal nerves and meninges (the tissues covering the spinal cord).”[2]  In spina bifida, this does not happen, causing “the spinal cord and meninges (the tissues covering the spinal cord) to stick out of the child’s back.”[3]

Prozac Lawyer Celexa Lawyer SSRI Birth Defect Lawsuit SSRI Attorney - Spina Bifida

In the general population, spina bifida “may affect as many as 1 out of every 800 infants,”[4] but several risk factors that increase the chances of a baby being born with spina bifida have recently been established.  First, low levels of the vitamin folic acid in pregnant mothers are currently believed to place newborns at risk because of folic acid’s known role in the development of the brain and spinal cord.[5]  It is also believed that a virus may play a role in the incidence of spina bifida in newborns “since there is a higher rate of this condition in children born in the early winter months.”[6]  It has also recently been discovered that maternal use of selective serotonin reuptake inhibitor (SSRI) antidepressant drugs during pregnancy can dramatically raise the risk of spina bifida in newborns.  The main SSRI linked to spina bifida is Celexa®, but use of other SSRI drugs such as Zoloft®, Paxil®, Prozac®, and Lexapro® may also place children at increased risk.

 

Signs of Spina Bifida

Signs that your child may be born with spina bifida are numerous.  Symptoms include “loss of bladder or bowel control,”[7] “partial or complete lack of sensation,”[8] “partial or complete paralysis of the legs,”[9] “weakness of the hips, legs, or feet of a newborn,”[10] “abnormal feet or legs, such as clubfoot,”[11] “build up of fluid inside the skull (hydrocephalus),”[12] “hair at the back part of the pelvis called the sacral area,”[13] and “dimpling of the sacral area.”[14]

Much of the time, a neurologist can test for spina bifida before birth with a blood test known as a “quadruple screen,”[15] which evaluates the newborn’s level of the protein “maternal alpha fetoprotein,”[16] as higher levels of maternal alpha fetoprotein are indicative of (but do not confirm) a spina bifida diagnosis.[17]  Confirmation of a spina bifida diagnosis before birth requires either pregnancy ultrasound or aminocentesis.[18]

After birth, a physician may see that a child has spina bifida though a neurologic examination, which “may show that the child has loss of nerve-related functions below the defect. For example, watching how the infant responds to pinpricks at various locations may reveal where he or she can feel the sensations.  Tests done on the baby after birth may include x-rays, ultrasound, CT, or MRI of the spinal area.”[19]

 

Complications of Spina Bifida

Though this list may not be all-inclusive, PubMed Health states that complications of spina bifida can include:

  • “Difficult delivery with problems resulting from a traumatic birth, including cerebral palsy and decreased oxygen to the brain
  • Frequent urinary tract infections
  • Hydrocephalus
  • Loss of bowel or bladder control
  • Meningitis
  • Permanent weakness or paralysis of legs”[20]

Research Links Spina Bifida to Maternal Use of SSRI Antidepressants

A study from Finland published in a 2011 edition of Obstetrics and Gynecology has found a strong link between maternal use of SSRIs during pregnancy and spina bifida.  This study, published by Heli Malm, MD, Ph.D. et al. has found that infants born to mothers who used Celexa® during pregnancy were about 2.4 times more likely to be born with neural tube defects such as spina bifida than were children born to mothers who did not use SSRIs during pregnancy.[21]

Treatment for Spina Bifida

Usually, surgery early on in a child’s life is required to correct spina bifida because it is dangerous for the child to have its spinal cord partially exposed, unprotected by the spine.  Sadly, “most children will require lifelong treatment for problems that result from damage to the spinal cord and spinal nerves. This includes:

  • Gentle downward pressure over the bladder may help drain the bladder. In severe cases, drainage tubes, called catheters, may be needed. Bowel training programs and a high fiber diet may improve bowel function.
  • Orthopedic or physical therapy may be needed to treat musculoskeletal symptoms. Braces may be needed for muscle and joint problems.
  • Neurological losses are treated according to the type and severity of function loss.
  • Follow-up examinations generally continue throughout the child’s life. These are done to check the child’s developmental level and to treat any intellectual, neurological, or physical problems.
  • Visiting nurses, social services, support groups, and local agencies can provide emotional support and assist with the care of a child with a myelomeningocele who has significant problems or limitations.”[22]

We are here to help you

Due to the fact that the manufacturers of Celexa® and other dangerous SSRI drugs do not include anything about birth defects such as spina bifida on their warning labels in the face of clear evidence of their capacity to increase the risk for newborns being born with major birth defects, a number of Celexa® lawsuits and other SSRI birth defect lawsuits are currently being filed.  If you used an SSRI during pregnancy, unaware of the risks posed to your developing child, and your child was born with spina bifida or another birth defect, please do not hesitate to contact our law firm at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us for a free, no-obligation case consultation.

We have the experience, resources, and skills required to go up against even the largest of pharmaceutical companies and win the justice you and your family deserve.

[1] “Myelomeningocele – PubMed Health” PubMed Health. U.S. National Library of Medicine. © 2012 A.D.A.M., Inc. Available at <http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002525/> Accessed 4 February 2013

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.

[6] Ibid.

[7] Ibid.

[8] Ibid.

[9] Ibid.

[10] Ibid.

[11] Ibid.

[12] Ibid.

[13] Ibid.

[14] Ibid.

[15] Ibid.

[16] Ibid.

[17] Ibid.

[18] Ibid.

[19] Ibid.

[20] Ibid.

[21] Malm, H., et al. (2011) “Selective Serotonin Reuptake Inhibitors and Risk for Major Congenital Anomalies” Obstetrics and Gynecology Vol. 118, Issue 1; pp. 111-120.

[22] “Myelomeningocele – PubMed Health” PubMed Health. U.S. National Library of Medicine. © 2012 A.D.A.M., Inc. Available at <http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002525/> Accessed 4 February 2013

A ventricular septal defect is a birth defect characterized by a small hole between the right and left ventricles of the heart that does not close after birth as it normally should.

PubMed Health, a service of the United States National Library of Medicine, explains it this way:

“Before a baby is born, the right and left ventricles of its heart are not separate. As the fetus grows, a wall forms to separate these two ventricles. If the wall does not completely form, a hole remains. This hole is known as a ventricular septal defect, or a VSD.

Ventricular septal defect is one of the most common congenital heart defects. The baby may have no symptoms, and the hole can eventually close as the wall continues to grow after birth. If the hole is large, too much blood will be pumped to the lungs, leading to heart failure.”[1]

Most often, a VSD will close shortly after birth, and the affected baby will have no symptoms nor will he or she suffer any significant health problems.[2]

Paxil Lawyer Prozac Lawyer Zoloft Lawyer Celexa Lawyer SSRI Birth Defect Lawsuit SSRI Attorney - Ventricular Septal Defect

Sometimes, however, a VSD does not close on its own, and the infant will require medication and surgery to ensure healthy development.  PubMed Health explains, “Babies with a large VSD who have symptoms related to heart failure may need medicine to control the symptoms and surgery to close the hole. Medications may include digitalis (digoxin) and diuretics.

If symptoms continue even with medication, surgery to close the defect with a Gore-tex patch is needed. Some VSDs can be closed with a special device during a cardiac catheterization, although this is rarely done.”[3]

While most of the time ventricular septal defects are treated safely, if a large defect goes untreated, severe complications may occur, including “Aortic insufficiency (leaking of the valve that separates the left ventricle from the aorta),”[4] “damage to the electrical conduction system of the heart during surgery (causing an irregular heart rhythm),”[5] “delayed growth and development (failure to thrive in infancy),”[6] “heart failure,”[7] “infective endocarditis (bacterial infection of the heart),”[8] and “pulmonary hypertension (high blood pressure in the lungs) leading to failure of the right side of the heart.”[9]

Ventricular Septal Defects and Maternal SSRI Use During Pregnancy

Recently, a great deal of research has come out linking maternal use of selective serotonin re-uptake inhibitors (SSRIs) during pregnancy with an increased risk of bearing children with birth defects.  SSRI drugs such as Zoloft® and Paxil® regulate levels of serotonin in the brain, a chemical involved in mood regulation, and recently found to play a key role in fetal development.  Because any medication used by an expecting mother is also passed to the developing child, the developing child’s serotonin levels become altered as well as a result of SSRI use during pregnancy, resulting in an increased risk of a variety of birth defects.

Much research has been published within the last decade linking maternal SSRI use with birth defects in general, but recently a specific link between SSRI use and ventricular septal defects has been established.  A 2011 study published by Dr. Heli Malm et al. in the medical journal Obstetrics and Gynecology titled “Selective Serotonin Reuptake Inhibitors and Risk for Major Congenital Anomalies” has conclusively shown that fluoxetine (Prozac®) use during pregnancy doubles the risk of ventricular septal defects in children.

Prognosis for Ventricular Septal Defects

Thankfully, the prognosis for most ventricular septal defects is good.  PubMed Health reassures, simply stating, “Many small defects will close on their own. Surgery can repair defects that do not close.”[10]

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.

[1] “Ventricular Septal Defect – PubMed Health” PubMed Health. U.S. National Library of Medicine. © 2012 A.D.A.M., Inc. Available at <http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002089/> Accessed 30 January 2013

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.

[6] Ibid.

[7] Ibid.

[8] Ibid.

[9] Ibid.

[10] Ibid.

Published in a 2011 edition of the medical journal Obstetrics and Gynecology, a study by Dr. Heli Malm (et al.) evaluated the risk of birth defects for children born to mothers who used selective serotonin-reuptake inhibitors (a type of antidepressant medication) during pregnancy.  Drugs whose danger was evaluated included fluoxetine (Prozac®, Sarafem®, Fontex®, and others), paroxetine (Paxil®, Aropax®, Pexeva®, Seroxat®, and Sereupin®), and citalopram (Celexa®, Cipramil®).  The results were truly shocking.

Prozac® Birth Defects

Children born to mothers who used fluoxetine during pregnancy were found to be at twice the risk for ventricular septal defects (VSD) than were other children.[1]  While the background risk for a VSD is low (about 0.5% of all newborns[2]), any increased risk for this ailment is a very serious problem.  A ventricular septal defect means that the hole between the right and left ventricles of the heart that normally exists before birth does not close by the time the child is born.  Though most of the time, small VSDs close shortly after birth, larger ones may require heart surgery in the newborn.

Left untreated, a large VSD may result in poor brain grown or development,[3] and according to the medical encyclopedia MedlinePlus, a service of the National Library of Medicine and the National Institutes of Health, a large VSD may be complicated by:

  • “Aortic insufficiency (leaking of the valve that separates the left ventricle from the aorta)
  • Damage to the electrical conduction system of the heart during surgery (causing an irregular heart rhythm)
  • Delayed growth and development (failure to thrive in infancy)
  • Heart failure
  • Infective endocarditis (bacterial infection of the heart)
  • Pulmonary hypertension (high blood pressure in the lungs) leading to failure of the right side of the heart”[4]

Read more on this birth defect caused by SSRI use during pregnancy here.

Paxil® Birth Defects

Mothers who used paroxetine during pregnancy were found to unknowingly place their newborns at more than four times the risk than other newborns for being born with a right ventricle outflow tract defect.[5]

Defects in the right ventricle outflow tract usually consist in an obstruction of the right ventricle outflow tract, resulting in a decrease in the amount of blood able to reach the lungs, where it is filled with oxygen to be used in organs throughout the body.  The danger that results from a right ventricle outflow tract defect ranges with the severity of the defect.  Defects may go unnoticed and not change the patient’s quality of life, defects require heart surgery, and in some cases, defects can be fatal.

Celexa® Birth Defects

Finally, this study found that infants whose mothers used citalopram during pregnancy had more than twice the risk of being born with neural tube defects than were infants whose mothers did not use any antidepressant medications during pregnancy.[6]

The neural tube is a “tubular structure that results from the folding of tissue along the back of vertebrate embryos and develops into the brain and spinal cord,”[7]  and defects of the neural tube can refer to a variety of conditions, including spina bifida[8] and anencephaly.[9]

Spina bifida is a condition that occurs if “the fetal spinal column doesn’t close completely during the first month of pregnancy,”[10] resulting in “nerve damage that causes at least some paralysis.”[11]  Children with spina bifida may have trouble learning, “urinary and bowel problems or hydrocephalus, a buildup of fluid in the brain.”[12]

Sadly, like many neurological disorders, there is no cure for spina bifida.

Anencephaly, another terrible congenital disorder that can be caused by a neural tube defect, is a condition in which much of a fetus’s brain does not develop, resulting in still birth or death shortly after birth.  While there is no cure for this ailment, it is very rare in the general population.  However, any means of reducing the change that one’s child will be born with anencephaly should be taken – specifically, the cessation of SSRI drugs during pregnancy.

[1] Malm, H., et al. (2011) “Selective Serotonin Reuptake Inhibitors and Risk for Major Congenital Anomalies” Obstet Gynecol Vol. 118, No. 1; p. 111-120

[2] “Ventricular Septal Defect” Health Topics © 1999-2013 Cincinnati Children’s Hospital Medical Center available at <http://www.cincinnatichildrens.org/health/v/vsd/> accessed 16 January 2013

[3] Ibid.                                                                                                                                                                 

[4] “Ventricular Septal Defect: MedlinePlus Medical Encyclopedia” MedlinePlus, U.S. National Library of Medicine, National Institutes of Health. © 1997-2013, A.D.A.M. available at <http://www.nlm.nih.gov/medlineplus/ency/article/001099.htm> page updated 27 December 2012, accessed 16 January 2013

[5] Malm, H., et al. (2011) “Selective Serotonin Reuptake Inhibitors and Risk for Major Congenital Anomalies” Obstet Gynecol Vol. 118, No. 1; p. 111-120

[6] Malm, H., et al. (2011) “Selective Serotonin Reuptake Inhibitors and Risk for Major Congenital Anomalies” Obstet Gynecol Vol. 118, No. 1; p. 111-120

[7] “Neural Tube” The American Heritage® Science Dictionary © 2000 Houghton Mifflin Company available at <http://www.thefreedictionary.com/neural+tube> updated 2009, accessed 16 January 2013

[8] Ibid.

[9] “Neural Tube Defects: MedlinePlus” MedlinePlus, U.S. National Library of Medicine, National Institutes of Health. available at <http://www.nlm.nih.gov/medlineplus/neuraltubedefects.html> updated 7 January 2013, accessed 16 January 2013

[10] “Spina Bifida: MedlinePlus”  , U.S. National Library of Medicine, National Institutes of Health. available at <http://www.nlm.nih.gov/medlineplus/spinabifida.html> updated 7 January 2013, accessed 16 January 2013.

[11] Ibid.

[12] Ibid.

Published in a 2011 edition of the medical journal Obstetrics and Gynecology, a study by Dr. Heli Malm (et al.) evaluated the risk of birth defects for children born to mothers who used selective serotonin-reuptake inhibitors (a type of antidepressant medication) during pregnancy.  Drugs whose danger was evaluated included fluoxetine (Prozac®, Sarafem®, Fontex®, and others), paroxetine (Paxil®, Aropax®, Pexeva®, Seroxat®, and Sereupin®), and citalopram (Celexa®, Cipramil®).  The results were truly shocking.

Prozac® Birth Defects

Children born to mothers who used fluoxetine during pregnancy were found to be at twice the risk for ventricular septal defects (VSD) than were other children.[1]  While the background risk for a VSD is low (about 0.5% of all newborns[2]), any increased risk for this ailment is a very serious problem.  A ventricular septal defect means that the hole between the right and left ventricles of the heart that normally exists before birth does not close by the time the child is born.  Though most of the time, small VSDs close shortly after birth, larger ones may require heart surgery in the newborn.

Left untreated, a large VSD may result in poor brain grown or development,[3] and according to the medical encyclopedia MedlinePlus, a service of the National Library of Medicine and the National Institutes of Health, a large VSD may be complicated by:

  • “Aortic insufficiency (leaking of the valve that separates the left ventricle from the aorta)
  • Damage to the electrical conduction system of the heart during surgery (causing an irregular heart rhythm)
  • Delayed growth and development (failure to thrive in infancy)
  • Heart failure
  • Infective endocarditis (bacterial infection of the heart)
  • Pulmonary hypertension (high blood pressure in the lungs) leading to failure of the right side of the heart”[4]

Read more on this birth defect caused by SSRI use during pregnancy here.

Paxil® Birth Defects

Mothers who used paroxetine during pregnancy were found to unknowingly place their newborns at more than four times the risk than other newborns for being born with a right ventricle outflow tract defect.[5]

Defects in the right ventricle outflow tract usually consist in an obstruction of the right ventricle outflow tract, resulting in a decrease in the amount of blood able to reach the lungs, where it is filled with oxygen to be used in organs throughout the body.  The danger that results from a right ventricle outflow tract defect ranges with the severity of the defect.  Defects may go unnoticed and not change the patient’s quality of life, defects require heart surgery, and in some cases, defects can be fatal.

Celexa® Birth Defects

 Finally, this study found that infants whose mothers used citalopram during pregnancy had more than twice the risk of being born with neural tube defects than were infants whose mothers did not use any antidepressant medications during pregnancy.[6]

The neural tube is a “tubular structure that results from the folding of tissue along the back of vertebrate embryos and develops into the brain and spinal cord,”[7]  and defects of the neural tube can refer to a variety of conditions, including spina bifida[8] and anencephaly.[9]

Spina bifida is a condition that occurs if “the fetal spinal column doesn’t close completely during the first month of pregnancy,”[10] resulting in “nerve damage that causes at least some paralysis.”[11]  Children with spina bifida may have trouble learning, “urinary and bowel problems or hydrocephalus, a buildup of fluid in the brain.”[12]

Sadly, like many neurological disorders, there is no cure for spina bifida.

nencephaly, another terrible congenital disorder that can be caused by a neural tube defect, is a condition in which much of a fetus’s brain does not develop, resulting in still birth or death shortly after birth.  While there is no cure for this ailment, it is very rare in the general population.  However, any means of reducing the change that one’s child will be born with anencephaly should be taken – specifically, the cessation of SSRI drugs during pregnancy.

[1] Malm, H., et al. (2011) “Selective Serotonin Reuptake Inhibitors and Risk for Major Congenital Anomalies” Obstet Gynecol Vol. 118, No. 1; p. 111-120

[2] “Ventricular Septal Defect” Health Topics © 1999-2013 Cincinnati Children’s Hospital Medical Center available at <http://www.cincinnatichildrens.org/health/v/vsd/> accessed 16 January 2013

[3] Ibid.                                                                                                                                                                 

[4] “Ventricular Septal Defect: MedlinePlus Medical Encyclopedia” MedlinePlus, U.S. National Library of Medicine, National Institutes of Health. © 1997-2013, A.D.A.M. available at <http://www.nlm.nih.gov/medlineplus/ency/article/001099.htm> page updated 27 December 2012, accessed 16 January 2013

[5] Malm, H., et al. (2011) “Selective Serotonin Reuptake Inhibitors and Risk for Major Congenital Anomalies” Obstet Gynecol Vol. 118, No. 1; p. 111-120

[6] Malm, H., et al. (2011) “Selective Serotonin Reuptake Inhibitors and Risk for Major Congenital Anomalies” Obstet Gynecol Vol. 118, No. 1; p. 111-120

[7] “Neural Tube” The American Heritage® Science Dictionary © 2000 Houghton Mifflin Company available at <http://www.thefreedictionary.com/neural+tube> updated 2009, accessed 16 January 2013

[8] Ibid.

[9] “Neural Tube Defects: MedlinePlus” MedlinePlus, U.S. National Library of Medicine, National Institutes of Health. available at <http://www.nlm.nih.gov/medlineplus/neuraltubedefects.html> updated 7 January 2013, accessed 16 January 2013

[10] “Spina Bifida: MedlinePlus”  , U.S. National Library of Medicine, National Institutes of Health. available at <http://www.nlm.nih.gov/medlineplus/spinabifida.html> updated 7 January 2013, accessed 16 January 2013.

[11] Ibid.

[12] Ibid.