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Justinian C. Lane is a personal injury attorney who focuses his practice on helping individuals injured by prescription drugs and medical devices.

In 2003, a study by Dr. Victoria Hendrick et al. titled “Birth outcomes after prenatal exposure to antidepressant medication” was published in The American Journal of Obstetrics and Gynecology, aiming to evaluate the risk for congenital malformations in infants whose mothers used antidepressant medication during pregnancy.

Using many different parameters and studying different antidepressant drugs individually, the Hendrick et al. team established that mothers who used Prozac® (fluoxetine) during pregnancy at a high dose placed infants at a dramatically-increased risk for low birth weight.[1]  In fact, all of the infants studied who were born at a low birth weight were born to mothers who had used a high dose of Prozac® during pregnancy.[2]

While this study does not illuminate the how Prozac® causes low birth weight, it goes great length to elucidate a strong, statistically significant correlation between high-dosage Prozac® use during pregnancy and low birth weight.  Unfortunately, the manufacturer of Prozac® does not include anything on its warning label about the risk for low birth weight, so it is possible that expecting mothers place their developing children at risk for birth defect through no fault of their own.

Because of this withholding of information regarding the danger of a pharmaceutical by its manufacturer, a number of Prozac® birth defect lawsuits and Prozac® low birth weight lawsuits are currently being filed.  If you used Prozac® during pregnancy and your child was born with a congenital malformation or with a low birth weight, please do not hesitate to contact our team of Prozac® birth defects lawyers.

At your convenience, you may reach us by phone 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 win the justice your family deserves.

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


[1] Hendrick, V. et al. (2003) “Birth outcomes after prenatal exposure to antidepressant medication” Am J Obstet Gynecol 2003 Mar; 188(3): 812-5

[2] Ibid.

In 2006, a research study by Bérard et al., a Canadian research team, titled “First Trimester Exposure to Paroxetine and Risk of Cardiac Malformations in Infants: The Importance of Dosage” was published in Birth Defects Research (Part B) that made several important conclusions about the safety of Paxil® use during pregnancy.

In 1,403 infant-mother pairs studied in this research (all mothers used antidepressants during pregnancy) over 100 major birth defects were found.[1]  And while this constitutes a dramatic increase in the incidence of major birth defects – the rate for major birth defects in the general population is about 2%[2] – these findings did not conclude that SSRI (selective serotonin reuptake inhibitor) use raised the risk for birth defects compared to other antidepressants, broadly.

When dosage and timing of drug use were studied in particular, it was found that maternal SSRI use is far more risky for a developing child.  Children born to mothers who used more than 25mg of Paxil® (paroxetine) daily during the first trimester were more than twice as likely to be born with a major congenital malformation as were children born to mothers who used other antidepressants during pregnancy.  And, children born to mothers who used 25mg of Paxil® per day during the first trimester were more than three times as likely to be born with a major heart malformation as were children born to mothers who used other antidepressant medications during pregnancy.

Though the Bérard et al. study does not show how SSRIs cause birth defects, along with physician consultation, these findings may help guide one’s pharmaceutical choices during pregnancy.  If there is something that can be done to avoid excess risk for major birth defects without causing harm, it should be done.  Pregnant mothers should have the information required to make informed, quality decisions pertaining to the health of their child.

Regrettably, the manufacturers of Paxil® have not included adequate warnings regarding the increased risk for birth defects their product creates.  Because of this failure, many Paxil® birth defect lawsuits are currently being filed, seeking compensation for injury sustained to children placed at risk for birth defects through no fault of their mothers.  If you used Paxil® during pregnancy and your child was born with a congenital malformation, you may be entitled to financial compensation.  Please do not hesitate to contact our team of Paxil® birth defect lawyers for a free, no-obligation consultation at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.

We have the compassion, experience, and resources required to help your family every step of the way.


[1] Bérard, A., et al. (2006) “First Trimester Exposure to Paroxetine and Risk of Cardiac Malformations in Infants: The Importance of Dosage” Birth Defects Research (Part B) Vol. 80; pp. 18-27

[2] “Birth Defect Risks: Factors and Considerations” Baby Zone © Disney BabyZone.com Available at <http://www.babyzone.com/pregnancy/fetal-development/birth-defects-risks_70721> Accessed 15 February 2013

Patent foramen ovale (PFO) is a birth defect that occurs when then a hole between the right and left atria fails to close after birth.  It is can be caused by maternal use of SSRI drugs during pregnancy.  Anyone unlucky enough to have been born with PFO may now have just been dealt another blow:

 

The FDA issued the highest-risk label on St. Jude Medical’s (NYSE:STJ) recall of its Amplatzer TorqVue FX delivery system.

 

St. Jude recalled a component of its Amplatzer Occluder over concerns that part of the delivery system may fracture, potentially causing adverse consequences or even death, according to the FDA report.

The Amplatzer device was designed to treat a condition called patent foramen ovale, in which a naturally occurring hole in the heart fails to close after birth, potentially allowing blood clots to travel from 1 side of the hart to the other and then to the brain, causing a stroke.

 

Source: FDA slaps highest risk label on St. Jude Medical’s Amplatzer TorqVue FX recall | MassDevice

 

The recalled devices were those made from August 24th of 2012 through September 24th of 2012.  They were distributed from October 1st of 2012 through January 9th of 2012.  The recall was initiated on January 18th, but it took a little time to make its way to the FDA website.  Here is the FDA on the recall. 

 

I’m not sure how widely used the product was.  On the one hand, as many as 1 in 4 people may have a PFO.  (Many people never even know they have it.)  But on the other hand, this product was only manufactured for a month.  There can’t be ten million of them in the marketplace.  Time will tell if there will be any Amplatzer TorqVue lawsuits or other legal issues to blog about here.

Longtime readers of this (or any drug-related blog) know that the U.S. Supreme Court ruled that manufacturers of generic drugs cannot be sued for failure-to-warn claims.  The ruling created a legal injustice for those injured by generic drugs.

While every plaintiff’s lawyer has secretly hoped that Congress would fix the law, we’re all savvy enough to know that this polarized and partisan Congress would never do so.  And honestly, I’m not even sure if Obama would sign it – screeds from the right notwithstanding, Obama has not been a friend of lawyers or the injured.

But there is hope!  Pharmalot noted that the U.S. Department of Justice filed a court brief that indicates that the FDA is considering changing the very rule that the Supreme Court based its ruling on.  If the FDA does change the rule, generic drug manufacturers will once again be held accountable for the same conduct brand-name manufacturers are held accountable for:

“This is what the footnotes states: “This office has been informed that FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances. If such a regulatory change is adopted, it could eliminate preemption of failure-to-warn claims against generic-drug manufacturers“ (see page 15 of this brief).

To short, if the FDA were to make such a change in regulations, generic drugmakers could be sued in state courts if they become aware of evidence of serious side effects but do not take action to update the product labeling. We were alerted to this by Bob Pollock, a senior advisor at Lachman Consultants, and a former acting deputy director of the FDA Office of Generic Drugs.”

Source: FDA May Change Warning Regs For Generic Labels // Pharmalot

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.

In 2006, a study published in the Archives of Pediatric Adolescent Medicine by Dr. Rachel Levinston-Castiel et al aimed to evaluate whether or not children exposed to selective serotonin-reuptake inhibitors (SSRI) antidepressants before birth would exhibit symptoms of neonatal abstinence syndrome, a condition had by infants that became addicted to drugs or medications used by mothers before birth.  SSRI antidepressants evaluated in this study included Paxil®, Prozac®, Celexa®, Zoloft®, and Effexor®, the most popular of SSRI drugs used today.[1]

Data for this study was gathered from 120 infants, half of whom were exposed to one of these SSRIs during pregnancy.[2]  Of the 60 infants exposed to SSRIs, about one third of them exhibited symptoms of neonatal abstinence syndrome, compared with none of the infants who were not exposed to SSRIs.[3]  The main symptoms exhibited by infants suffering from neonatal abstinence syndrome were tremor, gastrointestinal disturbance, high-pitched cry, sleep disturbance, hypertonicity or myoclonus, and tachypnea.[4]  Thankfully, in only 13% of these children,[5] “symptoms are severe enough to meet the definition of a severe NAS”[6] (Neonatal Abstinence Syndrome).

PubMed Health, a prominent online medical encyclopedia provided by the United States National Library of Medicine and The National Institutes of Health, states that complications of NAS may include:

This encyclopedia also states that “neonatal abstinence syndrome can last from 1 week to 6 months.”[8]

Though the study groups of infants born to mothers who used Prozac®, Celexa®, Zoloft®, and Effexor® were too small for statistical significance, the study group of infants whose mothers used Paxil® was large enough to yield results with high statistical significance.[9]  Mothers who used Paxil® and caused neonatal abstinence syndrome with mild symptoms used an average of 23mg daily.[10]  If mothers used 27mg daily, symptoms of neonatal abstinence syndrome were severe.[11]

Illustrating how important specific levels of serotonin are for a developing fetus, Levinson-Castiel et al (2006) found that if mothers used 19mg of Paxil® or less each day, children had no symptoms of neonatal abstinence syndrome.[12]

Because this research was published in such a prominent medical journal as the Archives of Pediatrics and Adolescent Medicine, we have reason to believe that the manufacturers of Paxil® knew, or should have known, of these risks since at least 2006.  And as no change to the warning label was made, this information may be used in a Paxil lawsuit.

If your child was born with neonatal abstinence syndrome and you used Paxil® or another SSRI during pregnancy, you and your family may be entitled to financial compensation for injuries sustained to your child, and our team of Paxil® birth defect lawyers is here to help.  We have the experience, resources, and skills to go up against the largest pharmaceutical and win the justice you and your loved ones deserve.

At your convenience you may contact us 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] Levinson-Castiel, R., et al. (2006) “Neonatal Abstinence Syndrome After In Utero Exposure to Selective Serotonin Reuptake Inhibitors in Term Infants” Arch Pediatr Adolesc Med Vol. 160, Feb 2006. pp. 173-176

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.

[6] Ibid.

[7] “Neonatal Abstinence Syndrome – PubMed Health” PubMed Health. U.S. National Library of Medicine. National Institutes of Health. © 2012 A.D.A.M., Inc. Available at <http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0004566/> Accessed 11 February 2013

[8] Ibid.

[9] Levinson-Castiel, R., et al. (2006) “Neonatal Abstinence Syndrome After In Utero Exposure to Selective Serotonin Reuptake Inhibitors in Term Infants” Arch Pediatr Adolesc Med Vol. 160, Feb 2006. pp. 173-176

[10] Ibid.

[11] Ibid.

[12] Ibid.

Because depression is so common during pregnancy, “ranging between 7% and 19% in developed countries,”[1] a great deal of research is currently being published with regard to the safety of using antidepressant medications during pregnancy.  Recently, a number of birth defects have been associated with maternal use of SSRIs (selective serotonin reuptake inhibitors) during pregnancy, including serious heart and neural tube defects.  It has also recently been found that babies born to mother who had used these antidepressants during pregnancy were 60% more likely to be born early than babies born to mothers who did not use antidepressants during pregnancy.[2]

Adding to the plethora of research published about the danger of SSRI use for developing children, a recent study, the results of which were published in 2009 by Merlob et al., set out to evaluate whether or not SSRIs were cardiac teratorgens – that is, whether or not SSRIs caused heart defects.  A great deal of research has already been published reaching that very conclusion.  Evaluating 235 women who reported using SSRIs during pregnancy and comparing rates of heart defects in their children to those for the general population, Merlob et al found that children born to mothers were more than twice as likely to be born with heart defects than were other children.[3]

Further analyses revealed that Paxil® and Prozac® raised the risk for congenital (from birth) heart disease to 4.3% and 3.0%, respectively, while the rate in the general population for being born with a congenital heart defect is about half that, at 1.60%.[4]

Merlob et al corroborated the findings of other researchers, confirming the association between maternal SSRI use during pregnancy and ventricular septal defects, bicuspid aortic valve, and right superior vena cava to coronary sinus.[5]  While Merlob writes that “possible cardiac malformations will probably be mild,”[6] and the overall risk for malformation remains small, anything steps we can take to protect our children from undue harm should be taken, and pregnant women should consult their physicians about the use of SSRI or other treatment methods during pregnancy.

Due to the fact that the manufacturers of Paxil® and Prozac® do not report to users of these drugs the increased risk at which developing children are placed for being born with heart defects, those manufacturers may be held liable for injury sustained by your child.  If you used SSRI antidepressants during pregnancy and your child was born with a birth defect, please do not hesitate to contact our team of Paxil® lawyers and Prozac® lawyers for a free consultation at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.

We have the experience and resources needed to help you every step of the way in securing the justice you and your loved ones deserve.


[1] Stephansson, O., et al. “Selective Serotonin Reuptake Inhibitors During Pregnancy and Risk of Stillbirth and Infant Mortality” Journal of the American Medical Association Vol. 309, No. 1; pp. 48-54

[2] Lennestål, R., et al. (2007) “Delivery Outcome in Relation to Maternal Use of Some Recently Introduced Antidepressants” Journal of Clinical Pharmacology Vol. 27, No. 6; pp. 607-613

[3] Merlob, P., et al. (2009) “Are Selective Serotonin Reuptake Inhibitors Cardiac Teratogens? Echocardiographic Screening of Newborns with Persistent Heart Murmur” Clinical and Molecular Teratology Vol. 85; pp. 837-841

[4] Ibid.

[5] Ibid.

[6] Ibid.

Celexa® (citalopram) is a selective serotonin reuptake inhibitor (SSRI), one in a new class of antidepressant drugs.  These medications aim to influence (and raise) levels of a chemical called serotonin in the brain.  Serotonin is a neurotransmitter, a molecule that relays “messages” between brain cells, or neurons.  When a neuron fires, neurotransmitters like serotonin are released from the terminal end of the firing neuron, and are collected by the “head,” so to speak, of the next neuron in line, causing that receiving neuron to fire.  When a normal number of serotonin molecules (and other neurotransmitters) are released between certain neurons and taken up in sufficient quantity by the receiving neuron, a person experiences a normal mood, sleep-wake cycle, and appetite.

Because serotonin molecules “cost” your body a lot of energy to make, the body has developed a special system for reusing serotonin molecules that were not taken up by the receiving neuron by using special transporter molecules to recapture (“reuptake”) unused serotonin molecules in the firing neuron.  In people with depression, it is often the case that the “reuptake” process happens too quickly, and serotonin molecules are taken back too quickly to be used in sufficient number by the receiving neuron.  It is also possible, in depression, the capturing of serotonin molecules in the receiving neuron takes longer than in people without depression.

Whatever the case may be, it has been found that slowing (“inhibiting”) the reuptake of serotonin and thereby allowing it to remain between neurons longer, increasing the likelihood that serotonin molecules will bind to the receiving neuron, helps diminish symptoms of depression.

Celexa® is a very popular selective serotonin reuptake inhibitor, estimated to be used by 12 million patients worldwide.[1]  In 2005, a study was published reviewing the safety of Celexa for infants when mothers use the drug during pregnancy in the American Journal of Obstetrics and Gynecology that uncovered some startling facts.

This article, titled “Citalopram use in pregnancy: prospective comparative evaluation of pregnancy and fetal outcome,” by Anna Sivojelezova et al included 396 women, divided into three groups: 132 depressed women who used Celexa® during pregnancy, 132 depressed women who used other SSRIs during pregnancy such as Prozac®, Paxil®, Zoloft®, etc., and 132 women who did not use SSRIs during pregnancy.[2]  This study did not find a significant difference between the groups with respect to birth weight or with respect to length of pregnancy.[3]

However, the study did find several important differences between groups.  Sivojelezova found that the likelihood that a newborn would require treatment in a neonatal intensive care unit is more than four times higher if a child’s mother used Celexa® during pregnancy.  Though the low numbers of children and mothers included in the test group were too low to detect the likelihood of many birth defects (most birth defects associated with Celexa® use during pregnancy are far less common than 1 in 132), this study documents clearly that Celexa® use during pregnancy places infants at a substantially-increased risk for the need of neonatal intensive care.

Because this study demonstrates that Celexa® raises the risk for negative birth outcomes, it may be used in a Celexa lawsuit to illustrate to court that since at least 2005, the manufacturer of Celexa® knew or should been aware the dangers of its product.  And because the labels of Celexa include nothing about the likelihood that children born to mothers who used Celexa® during pregnancy require neonatal intensive care even since this study was published along with many others incriminating SSRI use during pregnancy, an increasing number of Celexa® birth defect lawsuits are currently being filed.

If you used Celexa® during pregnancy and your child was born requiring neonatal intensive care or another birth defect, please do not hesitate to contact our team of Celexa birth defects lawyers for a free, no-obligation case consultation.  When you are ready, contact us at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.

We have the knowledge, experience, and resources to fight even the largest pharmaceutical companies for the justice you and your loved ones deserve.

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


[1]Willetts J, Lippa A, Beer B. Clinical development of citalopram. J Clin Psychopharmacol 1999;19(5 Suppl 1):36S-46S.

[2] Sivojelezova, A. (2005) “Citalopram use in pregnancy: Prospective comparative evaluation of pregnancy and fetal outcome” American Journal of Obstetrics and Gynecology Vol. 193; pp. 2004-2009

[3] Sivojelezova, A. (2005) “Citalopram use in pregnancy: Prospective comparative evaluation of pregnancy and fetal outcome” American Journal of Obstetrics and Gynecology Vol. 193; pp. 2004-2009

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.

Overview of Persistent Pulmonary Hypertension of the Newborn

Persistent pulmonary hypertension of the newborn (PPHN) is a congenital heart defect (present at birth) characterized by the failure of the circulatory system of the fetus to transition properly for circulation outside the womb.  Before a child is born, it gains oxygen-laden blood directly from its mother and because its lungs are not used, very little blood is sent to the lungs of a developing fetus.  When that developing child is born and its lungs begin to breathe air, a change in blood pressure helps divert blood to the lungs for oxygenation.  In babies with PPHN, this transition does not take place and blood is not diverted to the lungs for oxygenation, thus depriving the newborn of vital oxygen in its blood.

The Children’s Hospital Colorado writes “The pulmonary artery – which, after birth, will carry blood from the heart to the lungs – instead sends blood directly back to the heart through a fetal blood vessel called the ductus arteriosus.”[1]  Normally, the increased pressure caused by air filling the lungs closes the ductus arteriosus, but in babies with PPHN, that does not occur.[2]

For babies with PPHN, “[even] though the baby is breathing, oxygen in the breathed air will not reach the bloodstream. Because the blood returning from the body is unable to enter the lungs properly – and instead flows through the still-open ductus arteriosus – it returns to the heart in an oxygen-poor state.”

 

Signs Your Child May Have PPHN

Signs of persistent pulmonary hypertension of the newborn include, but may not be limited to:

  • “ rapid breathing (also called tachypnea)
  • rapid heart rate
  • respiratory distress, including signs such as flaring nostrils and grunting
  • cyanosis (when the skin has a bluish tinge), even while the baby is receiving extra oxygen to breathe
  • Sometimes when examining a baby with PPHN, the doctor will hear a heart murmur (an extra or abnormal heart sound). With PPHN, a baby may also continue to have low oxygen levels in the blood while receiving 100% oxygen.”

 

Treatment for PPHN

The most important first aim of PPHN treatment is to maximize oxygen levels in the baby’s blood.  This often requires immediate transfer to a neonatal intensive care unit, where through a hole cut into the baby’s trachea, pure oxygen is delivered to the lungs though a tube powered by a mechanical ventilator.[3]

Most often, use of a mechanical ventilator and medication are enough to treat PPHN in a child,[4] but, “if other methods can’t reverse the PPHN and raise the baby’s oxygen levels to the necessary range, a type of intensive procedure called extracorporeal membrane oxygenation (ECMO) may be needed. ECMO requires major surgery, is complicated to monitor, and has potentially serious side effects associated with it. It is reserved for the sickest babies who are not responding to other forms of treatment.

The ECMO machine acts as an artificial heart and lung for the baby for several days while the baby’s lungs heal and recover. Although ECMO is very successful in treating PPHN, fewer than 100 hospitals (mostly children’s hospitals) in the United States have facilities that can provide this treatment.”[5]

 

Complications of PPHN

Persistent pulmonary hypertension of the newborn is a very serious ailment.  Even if it is observed and treated early, lack of oxygen to vital organs can cause major, permanent damage, such as “shock, heart failure, brain hemorrhage, seizures, kidney failure, multiple organ damage, and possibly even death.”[6]  Sometimes PPHN manifests as a symptom of another disease which can be treated, thus curing the PPHN, but other times it remains untreatable.[7]

Other complications of PPHN include feeding problems in the first few weeks of life and hearing problems that may be long-term.

 

Link between PPHN and Maternal Use of SSRI Drugs

In 2006, it was documented that maternal use of SSRI antidepressant drugs during pregnancy dramatically raises the risk of a child being born with persistent pulmonary hypertension of the newborn.  “SSRI” stands for selective serotonin reuptake inhibitor, and refers to a new class of psychiatric medications that regulate levels of a chemical called serotonin between brain cells.  It has long been known that serotonin plays a role in mood, appetite, and sleep regulation, but recent research by T.W. Sadler has shown that serotonin may also play a key role in fetal development.

The 2006 study documenting the link between maternal use of SSRI drugs during pregnancy and PPHN was published by Christina Chambers et al. and concluded that infants born to mothers who used SSRI drugs after the 20th week of gestation were 6.1 times more likely to be born with PPHN than were children born to mothers who had not used SSRIs during pregnancy.[8]

 

We Are Here to Help

Because the manufacturers of SSRI drugs such as Zoloft®, Paxil®, Celexa®, and Prozac® do not warn users of these medications of the elevated risk at which developing children are placed for being born with congenital malformations, the manufacturers of these medications may be held liable for injury incurred by users or newborn children of users.  If you used Paxil®, Zoloft®, or another SSRI during pregnancy and your child was born with PPHN, please do not hesitate to contact our team of SSRI birth defect lawyers for a free, no obligation case consultation at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.

We have the experience and resources needed to win compensation from even the largest of pharmaceutical companies and secure the justice your family deserves.


[1] “Persistent Pulmonary Hypertension of the Newborn (PPHN) – Children’s Hospital Colorado-Denver Area, Rocky Mountain Region” Children’s Hospital Colorado. © 1995-2008 The Nemours Foundation/KidsHealth. Available at <http://www.childrenscolorado.org/wellness/info/parents/20830.aspx> Reviewed December 2001, Accessed 5 February 2013.

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.

[6] Ibid.

[7] Ibid.

[8] Chambers, C. et al. (2006) “Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn” The New England Journal of Medicine Vol. 354, No. 6; pp. 579-587