The objective of a study titled “Neonatal Abstinence Syndrome After in Utero Exposure to Selective Serotonin Reuptake inhibitors in Term Infants”, written by researchers from the Neonatal Intensive Care Unit at Schneider Children’s Medical Center of Israel, led by R. Levinson-Castiel was to determine the prevalence and clinical characteristics of neonatal abstinence syndrome in neonates both exposed and not exposed to selective serotonin reuptake inhibitors in utero.  The study was a cohort study taken place in tertiary care centers.  In all, there were 120 term infants used in this study.  Sixty of these infants had prolonged utero exposure to paroxetine hydrochloride (Paxil), fluoxetine (Prozac), citalopram hydrobromide (Celexa), sertraline hydrochloride (Zoloft), and venlafaxine hydrochloride (Effexor).

Levinson-Castiel writes “Neonatal abstinence syndrome was assessed with the Finnegan score as follows: score of 8 or above, severe; score of 4 to 7, mild; and score of 0 to 3, normal. All infants were followed up with a standardized protocol that included repeated Finnegan score assessments and cardiorespiratory monitoring until normalization of the Finnegan score.”

Shockingly, it was found that eight of ten neonates exposed to SSRIs showed some symptoms of a neonatal abstinence syndrome, and that 100 percent of all nonexposed neonates had a normal Finnegan score.  Levinson-Castiel further states “In neonates who developed severe symptoms, the maximum mean daily Finnegan scores were recorded within 2 days after birth, although maximum individual scores were recorded as long as 4 days after birth.”  Though long term effects of SSRI exposure are yet to be determined, neonatal abstinence syndrome was recorded in 30 percent of the neonates exposed to SSRIs.

If you or a loved one used an SSRI during pregnancy and your child was born with a congenital malformation, your family may be entitled to significant financial compensation from the manufacturer of the drug used for the undue injury caused to those close to you.  For a free, no-obligation case consultation, contact our team of Paxil® birth defects lawyers, Prozac® birth defects lawyers, Celexa® birth defects lawyers, Zoloft® birth defects lawyers, and Effexor® birth defects lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you and your loved ones deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

Call today and see how we can help!

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 done titled “Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study” by  LH. Pedersen from the Department of Epidemiology, Institute of Public Health, Aarhus University, was to take a closer look between selective serotonin reuptake inhibitors taken during pregnancy and their ability to cause major congenital malformations.  The study was a population based cohort study that involved 493,113 children born in Denmark from 1996 to 2003.  The major malformations were categorized according to the European Surveillance of Congenital Anomalies with a different diagnostic grouping for heart defects and information on mothers and newborns were collected from nationwide registers on medical redemptions, delivery, and hospital diagnosis.

Author  LH. Pedersen states “Redemptions for SSRIs were not associated with major malformations overall but were associated with septal heart defects (odds ratio 1.99, 95% confidence interval 1.13 to 3.53). For individual SSRIs, the odds ratio for septal heart defects was 3.25 (1.21 to 8.75) for sertraline, 2.52 (1.04 to 6.10) for citalopram, and 1.34 (0.33 to 5.41) for fluoxetine.” That is to say that overall, risk for septal heart defects was increased more than 3-fold if a mother used Zoloft during pregnancy compared to controls.  Celexa use was shown to raise the risk for septal heart defects by a factor of 2.52,  and Prozac use raised the risk of having offspring with septal heart defects by 34%.

The use of more than one type of SSRI was associated with septal heart defects as well.  Overall, the absolute increase in the prevalence of malformations was low with individual drugs, the prevalence of septal heart defects was .5 percent among unexposed children and .9 percent for children whose mothers were prescribed an SSRI, but prevalence of malformations was found to be 2.1 percent among children whose mothers were prescribed more than one type of SSRI.

Pedersen concludes, stating simply “There is an increased prevalence of septal heart defects among children whose mothers were prescribed an SSRI in early pregnancy, particularly sertraline and citalopram. The largest association was found for children of women who redeemed prescriptions for more than one type of SSRI.”

This and other pieces of academic research like it may be used in a Zoloft septal heart defect lawsuit, Celexa septal heart defect lawsuit, or a Prozac septal heart defect lawsuit to demonstrate to a court that the manufacturers of these drugs knew, or should have known, the risk for septal heart defects associated with their products.  Due to the fact that the manufacturers of these drugs have failed time and again to warn women of the risk for birth defects associated with SSRI use, SSRI birth defect lawsuits have been filed all over the world.

For a free, no-obligation case consultation, contact our team of Zoloft® birth defects lawyers, Celexa® birth defects lawyers, Prozac® birth defects lawyers, and SSRI birth defects lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

Call today and see how we can help!

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

A study conducted by the Department of Psychological Medicine, King Edward Memorial Hospital for Women, Subiaco, Australia, titled “Placental Transfer of SSRI and SNRI Antidepressants and Effects On The Neonate”, investigated placental transfer and neurobehavioural effects in neonates exposed to venlafaxine (Effexor), sertraline (Zoloft), paroxetine (Paxil), fluvoxamine, fluoxetine (Prozac), escitalopram, and citalopram (Celexa).  The neonates of women receiving antidepressants during pregnancy were studied and cord and maternal drug concentrations were measured at birth.  Neurobehavioral tests were used to assess neonates and compared to controls.

Rampono states “Median cord/maternal distribution ratio was 0.7-0.86 (range) for SSRIs, 0.72 for the SNRI venlafaxine and 1.08 for the O-desmethyl metabolite.”  It was shown that exposed infants had abstinence scores significantly higher neonatal abstinence scores than controls on day 1.  Exposed infants also showed significantly greater brazelton scores for habituation, social interactive, motor and autonomic clusters, and serotonin.

This study found that transfer of SSRIs and SNRIs across the placenta were substantial.  Author Rampono J. further states that “Neonates developed mild behavioral symptoms in the early perinatal period but these were self-limiting and similar for both SSRIs and the SNRI venlafaxine.”

If you or a loved one used SSRI during pregnancy and your child was born with a birth defect, your family may be entitled to significant financial compensation from the manufacturer of the drug used for the undue injury, pain, and suffering incurred through no fault of your own.  At your convenience, contact our team of Effexor® birth defects lawyers, Zoloft® birth defects lawyers, Paxil® birth defects lawyers, Prozac® birth defects lawyers, Celexa® birth defects lawyers, and SSRI birth defect lawyers to receive a free, no-obligation case consultation.

(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 published by researchers from the OMNI Research Group within the Department of Obstetrics and Gynaecology at The University of Ottawa, in Ottawa ON, titled “The Use of Selective Serotonin Reuptake Inhibitors in Pregnancy”, was to update literature on the safety of using selective serotonin reuptake inhibitors during pregnancy.

For this study, author SW. Wen states “MEDLINE was searched for English-language papers published from 1985 to 2003 on human studies of SSRIs, using the key words “serotonin reuptake inhibitors,” “citalopram [(Celexa)],” “fluoxetine [(Prozac)],” “fluvoxamine,” “paroxetine [(Paxil)],” and “sertraline [(Zoloft)].””  Older studies on the safety of SSRIs in pregnancy were based on small samples from medical centers and had yielded inconsistent results.  This research team searched for and yielded 12,338 publications.  One of the things the Wen et al. (2003) team noticed was that clinicians are hesitant to prescribe anti depression drugs to pregnant women because of the potential risks to the fetus, making the management of pregnant women with depression very challenging.

The challenges that come with treatment of maternal depression can lead to worsening depression that can greatly compromise both maternal and fetal health.  Wen et al. (2003) also found that depression can impair bonding and child care in the postpartum period.  While there are still many questions and further investigations that need to be done and explored to accurately understand all of the dangerous surrounding SSRIs, many studies have shown that SSRI use during pregnancy is associated with a dramatically increased risk for a number of serious birth defects.

Having said that, the absolute risk for many of the birth defects associated with drugs like Celexa, Prozac, Paxil, Zoloft, and other SSRI drugs remains relatively low, and consultation with a specialist experienced in treating depression can be greatly helpful with the treatment of pregnant women with depression.  Population based studies done on a large scale are needed to comprehensively assess the safety of SSRIs in pregnant woman.

Due to the fact that thousands of women have used SSRIs during pregnancy unaware of the increased risk for birth defects associated with drugs like Paxil, Prozac, Celexa, and Zoloft, a number of SSRI birth defect lawsuits are currently being filed.

If you or a loved one used an SSRI during pregnancy and your child was born with a congenital malformation, you may be entitled to significant financial compensation.  For more information, or a free, no-obligation case consultation, contact our team of SSRI lawyers at the information below.  We have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

Call today and see how we can help!

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 a 2005 edition of the Journal of the American Medical Association, a study by Dr. Eydie L. Moses-Kolko et al., titled “Neonatal Signs After Late In Utero Exposure to Serotonin Reuptake Inhibitors,” reviews the danger posed to infants whose mothers used serotonin reuptake inhibitors (SRIs), a new type of antidepressant and anti-anxiety medication.

Reviewing previously-published medical literature regarding neonatal outcomes after late in-utero exposure to SSRI drugs, the Moses-Kolko et al. team found that “compared with early gestational SRI exposure or no exposure, late SRI exposure carries an overall risk ratio of 3.0 … for neonatal behavioral syndrome.”[1]  That is, infants whose mothers used selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors late in pregnancy were three times as likely to be born with neonatal behavioral syndrome as were children whose mothers only used these drugs in early pregnancy or refrained entirely.

Signs and symptoms of neonatal behavioral syndrome include tremors, jitteriness, shivering, increased muscle tone, feeding/digestive disturbances, irritability/agitation, respiratory disturbances, increased reflexes, excessive crying, and sleep disturbances.[2]

Sixty-one percent of the cases of neonatal behavioral syndrome were related to Paxil® exposure, and twenty-two percent of the cases of neonatal behavioral syndrome were found to be caused by Prozac® exposure; other cases of neonatal behavioral syndrome were caused by other SSRIs.[3]

This Moses-Kolko piece also reviewed the findings of other contemporary research on the dangers of SSRI use in pregnancy.  Some of the findings cited associate SSRI use with “major congenital anomalies,”[4] “poor neonatal adaptation,”[5] “prematurity,”[6] “respiratory difficulties,”[7] and “low birth weight.”[8]  Other birth defects associated with SSRI use during pregnancy can be found here.

Because the manufacturers of Paxil®, Prozac®, and other SSRIs do not include specific, overt warnings for users regarding the increased risk of birth defects, many SSRI lawsuits are currently being filed.  If you used Paxil® or Prozac® during pregnancy and your child was born with neonatal behavioral syndrome or another congenital malformation, please do not hesitate to contact our team of Paxil® birth defect lawyers and Prozac® birth defect lawyers.

When you are ready, you may call or e-mail for a free, no obligation case consultation at (855) 452-5529 or justinian@dangerousdrugs.us.  We have the skills, resources, and experience required to win the justice you and your loved ones deserve.

 


[1] Moses-Kolko, E.L., et al. (2005) “Neonatal Signs After Late In Utero Exposure to Serotonin Reuptake Inhibitors” Journal of the American Medical Association Vol. 293, No. 19; pp. 2372 – 2383

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.

[6] Ibid.

[7] Ibid.

[8] Ibid.

A 2006 study from Denmark, published in the medical journal Epidemiology, has evaluated the risk for birth defects and other neonatal complications that results from maternal use of SSRI drugs during pregnancy.  “SSRI” stands for selective serotonin reuptake inhibitor and represents a new class of antidepressant drugs that change levels of serotonin in the brain.  Serotonin plays an important role in mood, appetite, and sleep regulation, but it has also recently been found that serotonin plays an important role in fetal development.  In the last ten to fifteen years, a great deal of research has come out linking maternal SSRI use in pregnancy and birth defects, and this study from Denmark aimed to further evaluate that risk.

In their paper titled “Maternal Use of Selective Serotonin Reuptake Inhibitors and Risk of Congenital Malformation,” the Wogelius et al team studied 1051 women who used SSRI drugs during the first trimester of pregnancy, 453 who used SSRIs during the remaining trimesters, and compared the health of children born to these women to children born to 150,780 women who did not use SSRIs during pregnancy.

Of the children born to the 150,780 women who did not use SSRIs during pregnancy, 3.4% had children with birth defects, compared with 4.9% of children whose mothers used SSRIs during the first trimester of pregnancy, and 6.8% of children whose mothers used SSRIs during the last two trimesters of pregnancy.[1]

The congenital malformations that were associated with maternal SSRI use during pregnancy ranged in type, but could be grouped generally into three main kinds: 29% cardiovascular, 31% muscle and bone defects, and 14% were defects related to digestive organs.[2]

As this study was a prospective study aimed at evaluating correlations between increased rates of birth defects and maternal SSRI use, it does not provide us with biochemical proof of how SSRIs cause these birth defects.  Nonetheless, this study goes great length to demonstrate a strong connection between birth defects and SSRI use during pregnancy, and as such, this article may be used in a SSRI birth defect lawsuit to illustrate to a court that pharmaceutical companies knew, or should have known, of the increased risk for birth defects posed by the use of their products.

If you or a loved one used an SSRI during pregnancy and your child was born with a congenital malformation, you may be entitled to compensation from pharmaceutical companies for undue injury to your child caused by SSRI drugs.  At your convenience, you may contact our team of qualified, experienced SSRI birth defect lawyers at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us for a free, no obligation case consultation.

We have the resources and knowledge required to defend your family against the largest pharmaceutical companies, and we will be with you every step of the way.


[1] Wogelius, P. (2006) “Maternal Use of Selective Serotonin Reuptake Inhibitors and Risk of Congenital Malformation” Epidemiology Vol. 17, No. 6; pp. 701-704

[2] Ibid.

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

Anal atresia, or “imperforate anus,” is a congenital birth defect “in which the opening to the anus is missing or blocked.”[1]  PubMed Health, a prominent online medical encyclopedia curated by the U.S. National Library of Medicine, states that anal atresia may manifest in several different ways:

  • “The rectum may end in a blind pouch that does not connect with the colon.
  • The rectum may have openings to the urethra, bladder, base of the penis or scrotum in boys, or vagina in girls.
  • There may be narrowing (stenosis) of the anus or no anus.”[2]

Signs that your child was born with anal atresia are numerous and clear.  Symptoms include “anal opening very near the vagina opening in girls,”[3] the baby failing to defecate within the first 24 to 48 hours of life,[4] “missing or moved opening to the anus,”[5] “stool [passing] out of the vagina, base of penis, scrotum, or urethra”[6].

Treatment for Anal Atresia

MedlinePlus states that when planning treatment for your baby with anal atresia, “the infant should be checked for other problems, especially those affecting the genitals, urinary tract, and spine.

Surgery to correct the defect is needed. If the rectum connects with other organs, these organs will also need to be repaired. A temporary colostomy (connecting the end of the large intestine to the abdomen wall so that stool can be collected in a bag) is often needed.”[7]

Anal Atresia Linked to Maternal SSRI Use

In 2007, medical researcher Carol Louik et al. published research illustrating a clear link between maternal use of SSRIs during pregnancy with the development of a variety of birth defects including anal atresia.[8]  SSRIs are a new type of antidepressants such as Prozac®, Paxil®, Zoloft®, Celexa®, and others, that aim to increase the levels of serotonin between brain cells by blocking the “reuptake” of serotonin back into brain cells after a nerve fires.

While serotonin had been known to play a role in mood, appetite, and sleep, it has recently been established by TW Sadler et al that serotonin also plays a role in fetal development.  So, when a mother alters her own serotonin levels, and thus alters the levels of serotonin reaching her developing child, developmental complications may ensue.

Specifically, Carol Louik and her team found that maternal use of Prozac® during pregnancy raises the risk of bearing a child with anal atresia by 40%.[9]  Maternal use of Celexa® was associated with a three-fold increased risk of anal atresia,[10] and maternal use of Zoloft® was found to raise the risk of anal atresia by a shocking 440%.[11]

Prognosis for Anal Atresia

Thankfully, the outlook for babies with anal atresia is good.  Though complications such as constipation may occur,[12] MedlinePlus reassures, writing that “Most defects can successfully be corrected with surgery. Most children with mild defects do very well.”[13]

We are Here to Help

Because the manufactures of Prozac®, Celexa®, and Zoloft®, do not include on their warning labels anything to do with the variety of birth defects for which they raise the risk for development, many SSRI birth defects lawsuits are currently being filed.  If you used Zoloft®, Celexa®, or Prozac® during pregnancy and your child was born with anal atresia, you may be entitled to financial compensation for the injuries you and your family have incurred.  For a free, no-obligation case consultation, you may contact our law firm at your convenience by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.  We have the experience and resources required to defend the rights of your family.

 


[1] “Imperforate anus – 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/PMH0002132/> Last reviewed 1 May 2011, Accessed 1 February 2013

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.

[6] Ibid.

[7] Ibid.

[8] Louik, C. et al. (2007) “First-Trimester Use of Selective Serotonin-Reuptake Inhibitors and the Risk of Birth Defects” The New England Journal of Medicine Vol. 365, No. 26; pp. 2675-2683

[9] Ibid.

[10] Ibid.

[11] Ibid.

[12] “Imperforate anus: MedlinePlus Medical Encyclopedia. U.S. National Library of Medicine. National Institutes of Health. © 1997-2013 A.D.A.M., Inc. Available at <http://www.nlm.nih.gov/medlineplus/ency/article/001147.htm> Updated 24 January 2013, Accessed 1 February 2013

[13] Ibid.

Omphalocele is a congenital birth defect in which the intestines or other abdominal organs stick out of the baby’s navel, and is considered a type of hernia.  Babies born with omphalocele are at a dramatically increased risk for intestinal infection,[1] and “death of intestinal tissue,”[2] both of which are very serious medical conditions that may also lead to other debilitating health issues.

PubMed Health, a prominent online medical encyclopedia provided by the United States National Library of Medicine, states that “There are different sizes of omphaloceles.  In small ones, only the intestines stick out.  In larger ones, the liver or spleen may stick out of the body as well.”[3]

Zoloft Lawyer SSRI Birth Defect Lawsuit SSRI Attorney - Omphalocele

Treatment for Omphalocele

Treatment for omphalocele requires surgery, but that surgery is not necessarily performed immediately after birth.[4]  “A sac protects the abdominal contents and allows time for other more serious problems (such as heart defects) to be dealt with first, if necessary.

To fix an omphalocele, the sac is covered with a special man-made material, which is then stitched in place. Slowly, over time, the abdominal contents are pushed into the abdomen.

When the omphalocele can comfortably fit within the abdominal cavity, the man-made material is removed and the abdomen is closed.

Sometimes the omphalocele is so large that it cannot be placed back inside the infant’s abdomen. The skin around the omphalocele grows and eventually covers the omphalocele. The abdominal muscles and skin can be repaired when the child is older to achieve a better cosmetic outcome.”[5]

 

Omphalocele Linked to Maternal SSRI Use

A study published in a 2007 edition of The New England Journal of Medicine has shown that maternal use of SSRI (selective serotonin reuptake inhibitor) antidepressant drugs during pregnancy dramatically increase the risk for a child being born with omphalocele.  Specifically, Zoloft® (sertraline) use during pregnancy was found to make children 5.7 times more likely to be born with omphalocele than children born to mothers who did not use Zoloft® during pregnancy.[6]  For more on the specifics of this study, you may find the original research linking Zoloft® and omphalocele here.

 

Prognosis for Omphalocele

Fortunately, a full recovery from omphalocele is expected after surgery.[7] “However, omphaloceles often occur with other birth defects. How well a child does depends on which other conditions the child also has.

If the omphalocele is identified before birth, the mother should be closely monitored to make sure the unborn baby remains healthy. Plans should be made for careful delivery and immediate management of the problem after birth. The baby should be delivered in a medical center that is skilled at repairing omphaloceles. The baby’s outcome is improved if he or she does not need to be taken to another center for further treatment.

Parents should consider screening their unborn baby for other genetic problems that are associated with this condition.”[8]

 

Filing a Zoloft® Lawsuit for Omphalocele

Due to the fact that the manufacturer of Zoloft® failed to warn users of its product’s influence on the risk of omphalocele, it may be held liable for injuries its product caused.  If you used Zoloft® during pregnancy and your child was born with omphalocele or another birth defect, please do not hesitate to contact our law firm for a free, no-obligation case consultation.

At your convenience, you may contact our offices by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.  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.  We are here to help you every step of the way.


[1] Omphalocele – PubMed Health” U.S. National Library of Medicine © 2011 A.D.A.M. Medical Encyclopedia  available at <http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001989/> accessed 1 February 2013

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.

[6] Louik, C. et al. (2007) “First-Trimester Use of Selective Serotonin-Reuptake Inhibitors and the Risk of Birth Defects” The New England Journal of Medicine Vol. 356, No. 26. p. 2675-2683

[7] Omphalocele – PubMed Health” U.S. National Library of Medicine © 2011 A.D.A.M. Medical Encyclopedia  available at <http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001989/> accessed 1 February 2013

[8] Ibid.

Limb reduction deficits are congenital (from birth) malformations of the newborn’s body in which one or more of the limbs does not fully develop, either partially or fully, before birth.[1]  The United States Centers for Disease Control and Prevention (CDC) reports that in the general population, about 4 babies in every 10,000 are born born with a limb reduction deficit.  Recently, medical research has found that maternal use of certain SSRI drugs can dramatically raise that risk, up to 400% that in the normal population.[2]

The CDC states that “Babies and children with limb reduction defects will face various issues and difficulties, but the extent of these will depend on the location and size of the reduction. Some potential difficulties and problems include:

  • Difficulties with normal development such as motor skills
  • Needing assistance with daily activities such as self-care
  • Limitations with certain movements, sports, or activities
  • Potential emotional and social issues because of physical appearance”[3]

Needless to say, limb reduction deficits are a very serious birth defect.  Treatment usually requires prosthetic limbs,[4] “splints or braces,”[5] “surgery,”[6] or physical therapy.[7]  Limb reduction deficits have also found to be linked to heart defects, omphalocele, and gastroschisis.[8]

SSRIs and Limb Reduction Deficits

In 2007, medical researcher Carol Louik and her team published a study in the New England Journal of Medicine that sought to determine whether maternal use of selective serotonin-reuptake inhibitor (SSRIs) drugs during pregnancy caused the risk for birth defects to raise, and made several startling conclusions.  These depression drugs aimed at regulating levels of serotonin in the brain, a neurotransmitter that maintains mood levels, appetite, and sleep, also dispose children to being born with a variety of major heart defects and other ailments.

Concerning limb reduction deficits specifically, Louik and her team determined that maternal use of Zoloft® raises a child’s risk of being born with a limb reduction deficit by a factor of 3.9, and maternal use of Celexa® raises a child’s risk of being born with a limb reduction deficit four fold.

We are here to help!

Because warning for increased risk for these birth defects is omitted from the labeling of Zoloft® and Celexa® the pharmaceutical companies that manufacture these drugs may be held liable for the injuries they incur.  If you used one of these SSRIs or another SSRI such as Paxil®, Prozac®, or Lexapro® please do not hesitate to contact our team of highly skilled pharmaceutical lawyers at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us for a free, no-obligation consultation.

We have the experience and resources to go up against even the largest of pharmaceutical companies and win the justice your family deserves.  We are here to help you recover from the injury these dangerous drugs have caused.

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

 


[1] “CDC – Birth Defects, Upper and Lower Limb Reduction Defects – NCBDDD” Centers for Disease Control and Prevention.  US Department of Health and Human Services. Available at <http://www.cdc.gov/ncbddd/birthdefects/UL-LimbReductionDefects.html> Updated 25 February 2011, Accessed 31 January 2013

[2] Louik, C. et al. (2007) “First-Trimester Use of Selective Serotonin-Reuptake Inhibitors and the Risk of Birth Defects” The New England Journal of Medicine Vol. 365, No. 26; pp. 2675-2683

[3] “CDC – Birth Defects, Upper and Lower Limb Reduction Defects – NCBDDD” Centers for Disease Control and Prevention.  US Department of Health and Human Services. Available at <http://www.cdc.gov/ncbddd/birthdefects/UL-LimbReductionDefects.html> Updated 25 February 2011, Accessed 31 January 2013

[4] Ibid.

[5] Ibid.

[6] Ibid.

[7] Ibid.

[8] Rosano A, Botto LD, Olney RS, Khoury MJ, Ritvanen A, Goujard J, et al. Limb defects associated with major congenital anomalies: clinical and epidemiological study from the International Clearinghouse for birth defects monitoring systems. Am J Med Genet. 2000;93: 110-16.