January 2013

Cleft lip and cleft palate are birth defects characterized by the malformation of the mouth when there is not enough tissue in the mouth during early fetal development.[1]  This may occur either in the lip alone, in the roof of the mouth, or in both.  In cleft lip, the upper lip is split and divided.  In babies with cleft palate, there is a “split or opening in the roof of the mouth.  A cleft palate can involve the hard palate (the bony front portion of the roof of the mouth), and/or the soft palate (the soft back portion of the roof of the mouth).”[2]

Prominent child health website Kidshealth.org provides these helpful images for better understanding:

Prozac Lawyer Celexa Lawyer SSRI Birth Defect Lawsuit SSRI Attorney - Cleft Palate - KidsHealth.org

If left untreated, though most cleft lips or cleft palates are treated soon after birth, many problems may be associated with cleft palate, such as:

“Eating problems. With a separation or opening in the palate, food and liquids can pass from the mouth back through the nose. Fortunately, specially designed baby bottles and nipples that help keep fluids flowing downward toward the stomach are available. Children with a cleft palate may need to wear a man-made palate to help them eat properly and ensure that they are receiving adequate nutrition until surgical treatment is provided.

Ear infections/hearing loss. Children with cleft palate are at increased risk ofear infections since they are more prone to fluid build-up in the middle ear. If left untreated, ear infections can cause hearing loss. To prevent this from happening, children with cleft palate usually need special tubes placed in the eardrums to aid fluid drainage, and their hearing needs to be checked once a year.

Speech problems. Children with cleft lip or cleft palate may also have trouble speaking. These children’s voices don’t carry well, the voice may take on a nasal sound, and the speech may be difficult to understand. Not all children have these problems and surgery may fix these problems entirely for some. For others, a special doctor, called speech pathologist, will work with the child to resolve speech difficulties.

Dental Problems. Children with clefts are more prone to a larger than average number of cavities and often have missing, extra, malformed, or displaced teeth requiring dental and orthodontic treatments. In addition, children with cleft palate often have an alveolar ridge defect. The alveolus is the bony upper gum that contains teeth. A defect in the alveolus can (1) displace, tip, or rotate permanent teeth, (2) prevent permanent teeth from appearing, and (3) prevent the alveolar ridge from forming. These problems can usually be repaired through oral surgery.”[3]

Cleft Lip and Cleft Palate Associated with Maternal SSRI Use

It has recently been documented that a factor that increases the risk of a child being born with cleft lip or cleft palate is maternal use of SSRI drugs during pregnancy.  “SSRI” stands for selective serotonin reuptake inhibitor, a type of medication that regulates the concentration of serotonin, a type of chemical called a neurotransmitter, a chemical messenger in the brain that helps regulates mood, appetite, and the sleep cycle.

In 2007, Carol Louik et al. documented that if a pregnant mother-to-be used any SSRI, the risk for her baby being born with a cleft lip, with or without cleft palate as well, was raised by 50%.[4]

If an expecting mother used fluoxetine (Prozac®), the risk was found to be raised by 80% compared to the rate among infants whose mothers did not use SSRIs during pregnancy.[5]  Another specific drug associated with an increased risk for cleft palate was citalopram (Celexa®), increasing the risk for cleft palate over three times that in the general population,[6] which is normally about 1 in 2500 babies.[7]

Louik’s startling findings published in The New England Journal of Medicine show us that though cleft lip may not be able to be avoided entirely, there are ways to avoid unduly increased risk of your baby being born with this birth defect.

Treatment and Outlook for Cleft Lip and Cleft Palate

Thankfully, there are ways to treat cleft lip and cleft palate if your baby is born with the ailment.  PubMed Health, a service of the United States National Library of Medicine, states that “Surgery to close the cleft lip is often done when the child is between 6 weeks and 9 months old. Surgery may be needed later in life if the problem has a big effect on the nose area.”[8]

“A cleft palate is usually closed within the first year of life so that the child’s speech develops normally. Sometimes a prosthetic device is temporarily used to close the palate so the baby can feed and grow until surgery can be done.”[9]

PubMed Health continues, reassuring that “Most babies will heal without problems.”[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] “Cleft lip and palate – 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/PMH0002046/> Last Reviewed 1 May 2011, Accessed 31 January 2013.

[2] “Cleft Lip and Cleft Palate: Causes and Treatments” WebMD. © 2005-2013 WebMD, LLC. Available at <http://www.webmd.com/oral-health/guide/cleft-lip-cleft-palate> Accessed 31 January 2013

[3] Ibid.

[4] 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

[5] Ibid.

[6] Ibid.

[7] “Cleft lip and palate – 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/PMH0002046/> Last Reviewed 1 May 2011, Accessed 31 January 2013.

[8] Ibid.

[9] Ibid.

[10] Ibid.

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.

A recent study published in the British Journal of Medicine has investigated the connection between maternal use of selective serotonin reuptake inhibitor drugs (SSRIs) such as Zoloft®, Paxil®, Prozac®, Celexa®, and Lexapro® during pregnancy and the development of persistent pulmonary hypertension in the newborn.  This study, published by Helle Kieler et al. corroborates earlier research that had established the connection between mother use of SSRIs during pregnancy and children being born with persistent pulmonary hypertension, such as that of Christina Chambers et al. (2006) published in the New England Journal of Medicine.

Persistent pulmonary hypertension of the newborn (PPHN) is a congenital (present at birth) heart condition in which the child does not adjust to breathing outside the womb.  Before birth, an infant does not use his or her lungs, and blood simply bypasses the lungs.  When the child takes his or her first breath though, a change in pressure in the lungs draws blood to the lungs and helps close passageways in the heart used in circulation before birth.  In babies with PPHN, however, “these changes may not occur and the baby’s circulation returns back to the fetal system with blood directed away from the lungs.”[1]  When blood is not directed to the lungs, it cannot be oxygenated, and thus essentially induces a degree of suffocation in the newborn.

To evaluate whether or not maternal use of SSRI drugs during pregnancy was correlated with this birth defect, the Kieler team undertook a “population based cohort study using data from the national health registers”[2] of Denmark, Finland, Iceland, Norway, and Sweden.  Of the 11,014 women found to have used SSRIs after the 20th gestational week,[3] 33 infants were born with PPHN.[4]  While this may seem like a small number of cases given the number of women who used SSRIs late in pregnancy, it is not.

Persistent pulmonary hypertension of the newborn is a very rare condition, normally affecting about 12 in 10,000 infants.[5]  Kieler’s findings show that when mothers use SSRIs late during pregnancy, the risk for PPHN is doubled.  Sadly, it is stated at the conclusion of Kieler’s piece that “Around 15% of infants with persistent pulmonary hypertension of the newborn will die.”[6]

Kieler also evaluated the relative danger of different SSRI drugs and found that while some SSRIs were more dangerous than others, all SSRIs tested significantly raised the risk of bearing children with PPHN:

Fluoxetine (Prozac®) was found to make children 2 times as likely to be born with PPHN.[7]

Citalopram (Celexa®) was found to make children 2.3 times as likely to be born with PPHN.[8]

Paroxetine (Paxil®) was found to make children 2.8 times as likely to be born with PPHN.[9]

Sertraline (Zoloft®) was found to make children 2.3 times as likely to be born with PPHN.[10]

Any steps one can take to lower the chance of inducing birth defects should be taken.  If you use SSRIs and have become pregnant, speak with your doctor before stopping SSRI medications, as adverse side-effects may occur.

Due to the fact that none of the labeling of these SSRIs includes any warning regarding PPHN, mothers around the country and across the globe are unknowingly placing their unborn children at risk of serious health conditions, including PPHN and others.  Because of this, a number of SSRI lawsuits are currently being filed for injury caused to unborn children by these drugs.  If you or a loved one used SSRIs during pregnancy and your child was born with PPHN or another defect, please do not hesitate to contact our law firm for a free consultation.

We can be reached by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.  We have the compassion, resources, and experience required to win the justice you and your family deserve, and we are here to help.


[1] “Persistent Pulmonary Hypertension” Children’s Hospital of the King’s Daughters Health System © 2013 Children’s Hospital of the King’s Daughters available at <http://www.chkd.com/g/content.aspx?pageid=P02400> reviewed 6 August 2011, accessed 21 January 2013

[2] Kieler, H., et al. (2011) “Selective serotonin reuptake inhibitors during pregnancy and risk of persistent pulmonary hypertension in the newborn: population based cohort study from the five Nordic countries” British Medical Journal Vol. 344:d8012

[3] Ibid.

[4] Ibid.

[5] Ibid.

[6] Ibid.

[7] Ibid.

[8] Ibid.

[9] Ibid.

[10] Ibid.

A study published in 2002 in the American Journal of Psychiatry by Dr. Gregory E. Simon, et al. goes great lengths to elucidate the danger of maternal use of antidepressant drugs during pregnancy.  In this study, Simon gathered data from the Group Health Corporation, “a prepaid health plan serving approximately 400,000 members in Washington State.”[1]

Reviewing several hundred children born to mothers who used SSRIs during pregnancy and comparing the health of those children to the health of children whose mothers had not used SSRIs during pregnancy, Simon found that the risk of low birth weight for infants whose mothers used SSRIs was more than twice that of newborns in the general population.[2]  And, even more shockingly, risk of premature birth for babies born to mothers who had used such antidepressants was more than four times that of babies in the general population.[3]

Simon summarizes the findings of his team, stating “We found an association between SSRI exposure and lower gestational age with a consequent effect on birth weight.  For both measures, significant differences were seen in the SSRI group    but not in the tricyclic antidepressant group, suggesting a specific effect of SSRI exposure rather than a confounding effect of maternal depression.”[4]  If low birth weight and lower gestational age were simply consequences of maternal depression during pregnancy, we would expect that infants born to mother who used tricyclic antidepressants would exhibit the same risk for congenital complication as did infants born to mothers who used SSRIs.  This, however, was not the case, and thus SSRIs alone are implicated in playing a causal role in premature birth and low birth weight.

Concluding, Dr. Simon warns that mothers should exercise caution if using any antidepressant drugs during pregnancy, especially SSRIs.  Examples of SSRIs associated with birth defects are Paxil®, Prozac®, Zoloft®, Celexa®, and others.  Because the risks these drugs pose to developing infants are not included on the warning labels for these drugs, and have thus caused injury to thousands of infants around the world, Zoloft® lawsuits and Paxil® lawsuits (among others) are currently being filed.

If you believe your child was injured by Zoloft® or Paxil® side-effects, please do not hesitate to contact our law firm by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us for a free, no obligation consultation.  Our team of Zoloft® lawyers and Paxil® attorneys have the experience, resources, and skill required to bring even the largest pharmaceutical manufactures to justice and secure the compensation you and your loved ones deserve.


[1] Simon, G.E., et al. (2002) “Outcomes of Prenatal Antidepressant Exposure” American Journal of Psychiatry Vol. 159; p. 2056

[2] Simon, G.E., et al. (2002) “Outcomes of Prenatal Antidepressant Exposure” American Journal of Psychiatry Vol. 159; p. 2057

[3] Ibid.

[4] Simon, G.E., et al. (2002) “Outcomes of Prenatal Antidepressant Exposure” American Journal of Psychiatry Vol. 159; p. 2060

A recent study published in the Archives of General Psychiatry set out to determine whether it was worse for a developing fetus to be exposed to antidepressant drugs during gestation or to be carried to term by a mother-to-be who suffered from depression during pregnancy.  This study, published by Dr. Tim F. Oberlander et al. was titled “Neonatal Outcomes After Prenatal Exposure to Selective Serotonin Reuptake Inhibitor Antidepressants and Maternal Depression Using Population-Based Linked Health Data,” and as the title suggests, focused on the effects of a new type of antidepressant drugs, selective serotonin reuptake inhibitors (SSRIs) such as Prozac®, Zoloft®, Paxil®, Celexa®, and others.

Data for the Oberlander study was collected using three groups from the population of British Colombia, Canada: infants born to depressed mothers who used SSRIs during pregnancy, infants born to depressed mothers who did not use SSRIs, and a control group made up of infants born to mothers who did not suffer from depression (and also did not use SSRIs).  In all, participants totaled over 100,000 infant-mother pairs.[1]

Results showed that maternal depression alone contributes to low birth weight, but that use of SSRIs exacerbated that risk.  Furthermore, it was demonstrated that exposure to SSRIs during gestation fostered an increased risk of neonatal respiratory distress (13.9% vs 7.8%), jaundice (9.4% vs 7.5%), and feeding problems (3.9% vs 2.4%)[2] when compared with babies born to depressed mothers who did not use antidepressant medications.

Because common SSRI warning labels, such as those for Zoloft® or Paxil®, include no information regarding these risks posed the developing fetus, an increasing number of Zoloft® lawsuits and Paxil® lawsuits are currently being filed.  If you used Zoloft® or Paxil® during pregnancy and your child was born with these or other birth defects, including a variety of heart malformation defects such as septal defects or persistent pulmonary hypertension of the newborn, please do not hesitate to contact our law firm for a free consultation at (855) 452-5529 or contact me personally by e-mail at justinian@dangerousdrugs.us.  We have the experience and resources required to go up against even the largest of pharmaceutical manufacturers and win the compensation you and your family deserve.


[1] Oberlander, T.F., et al. (2006) “Neonatal Outcomes After Prenatal Exposure to Selective Serotonin Reuptake Inhibitor Antidepressants and Maternal Depression Using Population-Based Linked Health Data” Arch Gen Psychiatry Vol. 63; pp. 898-906

[2] Ibid.

In 2010, a Danish study published in the medical journal Clinical Epidemiology set out to evaluate the danger posed to infants born to mothers who used selective serotonin reuptake inhibitors (SSRIs, a new class of antidepressant drugs including Zoloft®, Paxil®, and Prozac®) during early pregnancy.

The study, published by Jette B. Kornum et al. compared the health of 213,712 babies born to mothers who did not use SSRIs during pregnancy to 2,062 women who did use SSRIs during pregnancy, [1] and found that overall, children born to mothers who used SSRIs were more likely to be born “with malformations”[2] (5.1% were born with malformations) than were children born to mother who did not use SSRIs during pregnancy (3.5%).[3]

Concerning cardiac malformations specifically, the Kornum piece established that maternal use of SSRIs during early pregnancy was associated with a 70% increased risk for heart-related birth defects[4] that “could be causal”[5].  This finding has also been corroborated by researchers around the world.

Because drugs such as Zoloft® and Paxil® (among others) do not include warnings about the risk of congenital heart malformation in newborns when expecting mothers used SSRIs during pregnancy, Zoloft® lawsuits and Paxil® lawsuits are currently being filed in increasing number across the country.  Our team of Zoloft® lawyers and Paxil® lawyers has the skill, resources, and compassion needed to secure the justice your family deserves.  If you or a loved one used SSRIs during pregnancy and your child was born with a birth defect, please do not hesitate to contact us for a free, no obligation consultation at (855) 452-5529 or e-mail me personally at justinian@dangerousdrugs.us.  We are here to help.


[1] Kornum, J.B., et al. (2010) “Use of selective serotonin-reuptake inhibitors during early pregnancy and risk of congenital malformations: updated analysis” Clinical Epidemiology Vol. 2; pp. 29-36

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.

On January 25th, the FDA announced that the drug Samsca (tolvaptan) “has the potential to cause irreversible and potentially fatal liver injury.”

ISSUE: Otsuka and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca. In a double-blind, 3-year, placebo-controlled trial in about 1400 patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and its open-label extension trial, 3 patients treated with the drug developed significant increases in serum alanine aminotransferase (ALT) with concomitant, clinically significant increases in serum total bilirubin. In the trials the maximum daily dose of Samsca administered (90 mg in the morning and 30 mg in the afternoon) was higher than the maximum 60 mg daily dose approved for the treatment of hyponatremia.

Source: Safety Alerts for Human Medical Products > Samsca (tolvaptan): Drug Warning – Potential Risk of Liver Injury

Although this is a new issue, the lawyers at my firm are investigating whether it will be appropriate to file any Samsca lawsuits on behalf of individuals who suffered liver damage while taking the drug Samsca.

As the news of the association between Samsca and liver injury is less than a week old, there is not a lot of information to go on, yet.  But if you’d like to have a Samsca lawyer contact you regarding a potential injury, e-mail me at justinian@dangerousdrugs.us or call toll-free at (855) 452-5529 and we will keep you informed as to what we find.

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.

A birth defect of the heart recently found to be associated with maternal use of SSRI drugs during pregnancy,[1] pulmonary valve stenosis is characterized by a narrowing (stenosis) of the pulmonary valve of the heart, the valve which opens to allow blood to flow from the right ventricle to the lungs for oxygenation.[2]

Specifically, pulmonary valve stenosis has been associated with maternal use of Paxil® (paroxetine) and Prozac® (fluoxetine).[3]

Paxil Lawyer Prozac Lawyer SSRI Birth Defect Lawsuit SSRI Attorney - pulmonary valve stenosis adam 2012
Pulmonary Valve Stenosis

 

PubMed Health, a service of the U.S. National Library of Medicine, states that when the condition is “moderate to severe,”[4] symptoms include:

The same page concerning pulmonary valve stenosis states that “symptoms may get worse with exercise or activity.”[6]

 

Treatment and Prognosis for Pulmonary Valve Stenosis

When the condition is mild, medication is usually sufficient for treatment of pulmonary valve stenosis.  However, if the condition is severe, surgery may be required “to repair or replace the pulmonary valve.”[7]

Generally, if the condition is mild, it will not worsen of the course of the patient’s life.  If the condition is moderate or severe, however, it is likely to worsen and eventually require surgery.[8]  But thankfully, most replacement valves can last for decades.[9]

Though the condition may be stabilized though surgical procedures, serious complications are associated with pulmonary valve stenosis.  According to PubMed Health, complications associated with pulmonary valve stenosis can include:

  • “Abnormal heartbeats (arrhythmias)
  • Death
  • Heart failure and enlargement of the right side of the heart
  • Leaking of blood back into the right ventricle (pulmonary regurgitation) after repair”[10]

 

We are here to help!

Due to the fact that Paxil® and Prozac® warning labels included no information regarding the increased risk of bearing children with pulmonary valve stenosis when the medications are used by expecting mothers, Paxil® birth defect lawsuits and Prozac® birth defect lawsuits are currently being filed, aimed at securing financial compensation for injuries sustained by families around the country.

If you or a loved one used an SSRI during pregnancy and your child was born with pulmonary valve stenosis, please do not hesitate to contact us at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us for a free, no obligation consultation.  Our Paxil® lawyers and Prozac® lawyers have the compassion, experience, and resources required to help you every step of the way.


[1] Diav-Citrin, O. et al. (2008) “Paroxetine and fluoxetine in pregnancy: a prospective, multicentre, controlled, observational study” British Journal of Clinical Pharmacology Vol. 66, No. 5; pp. 695-705.

[2] “Pulmonary valve stenosis – 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/PMH0002086/> Accessed 24 January 2013

[3] Diav-Citrin, O. et al. (2008) “Paroxetine and fluoxetine in pregnancy: a prospective, multicentre, controlled, observational study” British Journal of Clinical Pharmacology Vol. 66, No. 5; pp. 695-705.

[4] “Pulmonary valve stenosis – 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/PMH0002086/> Accessed 24 January 2013http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002086/

[5] Ibid.

[6] Ibid.

[7] Ibid.

[8] Ibid.

[9] Ibid.

[10] Ibid.

Coarctation of the aorta (CoA) is a heart defect present at birth characterized by “the narrowing of the major artery (the aorta) that carries blood to the body.”[1]  The American Heart Association states that “This narrowing affects blood flow where the arteries branch out to carry blood along separate vessels to the upper and lower parts of the body.  CoA can cause high blood pressure or heart damage.”[2]

While there may be no symptoms immediately after birth,[3] symptoms may arise within the first week of the child’s life that include, “congestive heart failure or high blood pressure.”[4]

As we can see from the below image, the vessel carrying red (oxygen-rich) blood from the heart is pinched, almost to the extent that blood cannot flow out to the body.

Paxil Lawyer SSRI Lawsuit SSRI Birth Defect Attorney Coarctation of the Aorta - A.D.A.M. 2012
Coarctation of the Aorta

Treating Coarctation of the Aorta

Treatment of Coarctation of the Aorta, when the condition is severe, usually requires surgery.[5]  The American Heart Association writes that though the surgery required is highly invasive, the “surgeon doesn’t have to open the heart to repair the coarctation. It can be fixed in several ways.  One way is for the surgeon to remove the narrowed segment of aorta.  Another option is to sew a patch over the narrowed section using part of the blood vessel to the arm or a graft of synthetic material.”[6]  These options are illustrated below.

Paxil Lawyer SSRI Lawsuit SSRI Birth Defect Attorney Coarctation of the Aorta Surgery 1
Coarctation of the Aorta Surgical Procedure
Paxil Lawyer SSRI Lawsuit SSRI Birth Defect Attorney Coarctation of the Aorta 2
Coarctation of the Aorta Surgical Procedure

 

In most cases, children that have undergone this surgery successful will grow up to lead normal lives, and will be able to participate in physical activity without restriction.[7]

 

Coarctation of the Aorta Linked to SSRI Use During Pregnancy

Recently, a study published in the British Journal of Pharmacology (Diav-Citrin et al, 2008) has shown that infants born to mothers who used a new type of antidepressant medication during pregnancy called selective serotonin-reuptake inhibitors (SSRIs) are more likely to be born with a range of heart defects.  One of the main findings of the Diav-Citrin piece was a link between Coarctation of the Aorta in newborns and maternal use of Paxil® (paroxetine) during pregnancy.

Though Paxil® has been found to pose so much danger to unborn children, Paxil® warning labels did not include any such information, thus placing thousands of children at risk for serious birth defects without the mother’s knowledge.  As such, many families are currently filing Paxil® birth defect lawsuits, seeking compensation for Paxil®-use related injuries to family members.

If you used Paxil® during pregnancy and your child was born with Coarctation of the Aorta, please do not hesitate to contact us at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us for a free, no obligation consultation.  We have the experience, skill, and resources to provide the justice your family deserves.


[1]“Coarctation of the Aorta (CoA)” The American Heart Association. © 2013 American Heart Association, Inc. Available at <http://www.heart.org/HEARTORG/Conditions/CongenitalHeartDefects/AboutCongenitalHeartDefects/Coarctation-of-the-Aorta-CoA_UCM_307022_Article.jsp> Updated 24 January 2013, Accessed 24 January 2013

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.

[6] Ibid.

[7] Ibid.