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News & Commentary on Prescription Drug & Medical Device Lawsuits

Autism, poor neurodevelopment linked to SSRIs in pregnancy

Posted in SSRI Birth Defects

An article titled “SSRI antidepressants: altered psychomotor development following exposure in utero?” that appeared in the February, 2013 edition of Prescrire International examines additional risks of prenatal exposure to selective serotonin reuptake inhibitor drugs (SSRIs).  To be clear, a number of other studies have linked adverse birth outcomes linked to SSRI exposure in years passed.

This team states “Selective serotonin reuptake inhibitor antidepressants (SSRIs) are sometimes prescribed to pregnant women. The potential consequences for the unborn child are gradually becoming clearer. In a case-control study of 298 children with autism and 1507 controls, 6.7% of mothers of autistic children had been prescribed an antidepressant during the year before delivery, compared to 3.3% of control mothers. The antidepressant was usually an SSRI. A dozen other small epidemiological studies of neurological development in children exposed to antidepressants in utero have provided mixed results. Two of these studies suggested a risk of psychomotor retardation. In practice, SSRI antidepressants should only be considered for pregnant women when non-drug measures fail and when symptoms are sufficiently serious to warrant drug therapy.” (emphasis added)

Citing a link to autism and poor neurodevelopment, this article can be used as evidence in a SSRI birth defect lawsuit to illustrate the the manufacturers of SSRIs knew, or should have known the risks associated with their products.  Due to the fact that these manufacturers failed to warn expecting mothers of these risks, SSRI lawsuits have been filed all over the world.

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

(855) 452 – 5529

justinian@dangerousdrugs.us

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

2013 – Researchers show that SSRIs (not maternal depression) cause poor neonatal outcomes

Posted in SSRI Birth Defects

Last summer, a team of researchers from University of British Columbia (Vancouver) led by G.E. Hanley published a study titled “Infant developmental outcomes following prenatal exposure to antidepressants, and maternal depressed mood and positive affect.” in Early Human Development.  This study examined the relationship between poor early childhood development and gestational exposure to selective serotonin reuptake inhibitor drugs (SSRIs).

Hanley: “Prenatal exposure to serotonin reuptake inhibitor (SRI) antidepressants has been associated with delays in early developmental milestones, but there remains uncertainty. Even among a subset of studies examining the Bayley Scales of Infant Development (BSID), some have reported normal mental and psychomotor development while others have suggested a delay in motor development. Given an increasing number of infants exposed to SRIs, furthering our understanding of the possible developmental implications of SRI exposure in utero is critical.”

This study reviewed the developmental status of 10-month-old children who were exposed to maternal SSRI drugs in pregnancy: “We examined 31 mother-child pairs exposed prenatally to SRIs and 52 mother-child pairs who were nonexposed.”

Results showed that “Infants exposed prenatally to SRIs scored significantly lower than nonexposed infants on gross motor (P=0.03), social-emotional (P=0.04) and adaptive behavior (P=0.05) subscales of the BSID-III, controlling for pre- and postnatal maternal depressed mood, smoking and alcohol use during pregnancy.”  This means that SSRI exposure, not maternal depression, was linked to poor neonatal outcomes.

Due to the fact that every year, thousands of expecting mothers use SSRIs unaware of these risks, SSRI birth defect lawsuits are currently being filed around the world.

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

(855) 452 – 5529

justinian@dangerousdrugs.us

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

Prozac, Pazil, Zoloft, Celexa linked to Persistent Pulmonary Hypertension of the Newborn (PPHN)

Posted in Celexa Birth Defects, Effexor Birth Defects, Paxil Birth Defects, Prozac Birth Defects, SSRI Birth Defects, Zoloft Birth Defects

Titled “Further findings linking SSRIs during pregnancy and persistent pulmonary hypertension of the newborn: clinical implications.”, this article appearing in the October, 2012 edition of CNS Drugs by M. Galbally et al., identifies persistent pulmonary hypertension of the newborn (PPHN) as a potential consequence of SSRI exposure before birth.

Galbally et al. (2012) writes “Persistent pulmonary hypertension of the newborn (PPHN) is a rare but potentially life-threatening neonatal condition. Several authors have suggested that late pregnancy exposure to selective serotonin reuptake inhibitors (SSRIs) may increase the risk of PPHN. This association has been investigated in seven published studies that have shown mixed findings based on diverse methods. Several methodological limitations may account for the diversity of findings, which include, in some studies, a lack of control for well established risk factors for PPHN. The methodological improvement in the most recent study tentatively suggests that infants prenatally exposed to SSRIs are approximately twice as likely to suffer PPHN. Further research on the biological mechanisms involved is required. Clinicians should consider late pregnancy exposure to SSRIs as one of several possible risks for PPHN, which has implications for both prescribing SSRIs to pregnant women and for neonatal care of SSRI-exposed infants.”

Since the manufacturers of SSRIs like Prozac, Paxil, Zoloft, Celexa, and others have failed time and again to adequately inform women of the risk for birth defects, SSRI birth defect lawsuits are currently being filed by the thousands.

If you or a loved one used SSRIs and gave birth to a child with a birth defect or who faced adverse birth outcomes, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of SSRI birth defect lawyers at the information provided below.  We have the compassion, experience, and resources required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

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

2006 – Persistent Pulmonary Hypertension Linked to SSRIs in Pregnancy

Posted in SSRI Birth Defects

A team of researchers from Sydney, Australia (led by M.P. Austin) published an article in a December, 2006 edition of Psychological Medicine titled “To treat or not to treat: maternal depression, SSRI use in pregnancy and adverse neonatal effects.” that attempted to clarify negative consequences of prenatal exposure to SSRI drugs like Prozac, Paxil, and Zoloft.  To be sure, many other studies have demonstrated that exposure to these drugs is linked to heart defects, autism, and poor neonatal development.

Here is the abstract for that article:

“Recent pharmaceutical company and regulatory body circulars warning against the use of selective serotonin reuptake inhibitors (SSRIs) in late pregnancy have left clinicians in somewhat of a quandary as to how to manage their more severely depressed patients in pregnancy. Conversely, up to 75% of depressed women ceasing their antidepressants periconceptually will relapse. Studies reporting on adverse neonatal outcomes following exposure to SSRIs in the latter half of pregnancy suggest that the fetus is exposed to significant concentrations of these medications during this time. Adverse neonatal effects affecting the respiratory, gastrointestinal and neurological systems are, however, predominantly mild and self-limiting. One small retrospective case study suggests that SSRI exposure in the latter half of pregnancy may be associated with an increased risk of persistent pulmonary hypertension of the neonate (PPHN), however, the absolute risk of developing PPHN remains very small and these findings will require replication with a prospective study. While the studies to date suggest the need to closely monitor SSRI-exposed neonates in the immediate postnatal period, preferably with a neonatal withdrawal scale and access to neonatology services, there is currently no clear argument for women to be weaned off their SSRI in late pregnancy. The decision to use SSRIs at this time will have to be made on a case-by-case basis in close consultation with the mother and her partner.” (emphasis added)

Because the manufacturers of many SSRI drugs have failed to make the risks of prenatal exposure to SSRIs clear to the public, thousands of SSRI birth defect lawsuits are currently being filed.

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

(855) 452 – 5529

justinian@dangerousdrugs.us

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

More research links poor development with SSRI exposure

Posted in SSRI Birth Defects

An article in Early Human Development (February, 2013) by M.V. Smith et al. titled “Neurobehavioral assessment of infants born at term and in utero exposure to serotonin reuptake inhibitors.”, from The Yale School of Medicine delves further into the link between prenatal SSRI exposure and adverse birth outcomes.  Selective serotonin reuptake inhibitor drugs (SSRIs) are psychiatric medications that work to regulate serotonin concentrations in the brain, serotonin being a neurotransmitter that plays a key role in mood, appetite, sleep, and prenatal development.

Smith et al. (2013) write “Some studies report neurobehavioral symptoms in neonates exposed to serotonin reuptake inhibitors (SRIs) in utero. However, maternal psychiatric illness during the last trimester of pregnancy, as a confounding factor, has not always been assessed.”  Accordingly, the aims of this present study were to compare “neurobehavioral complications among neonates who were born to euthymic women who either took or did not take an SRI during the last trimester of pregnancy.”

Subjects included in this small study were “67 infants (61 controls and 6 exposed to SRIs).”  The team found that “Infants exposed to SRIs in the third trimester had poorer motor development, lower 5-minute APGAR scores, and shorter mean gestational age as compared to unexposed infants.”  For clarity, APGAR score is a measure of neonatal adaptation (to life outside the womb), and higher scores indicate better adaptation.

“Results of this study show differences in autonomic and gross motor activity between neonates who were or were not exposed to SRIs in utero after controlling for active maternal psychiatric illness.”  Because of studies like this, SSRI birth defect lawsuits have been filed in great number.

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

(855) 452 – 5529

justinian@dangerousdrugs.us

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

Huge birth defect increase with Depacon / Depakene / Depakote in pregnancy

Posted in Depacon / Depakene / Depakote

Today, I came across an article from the February, 2012 edition of The Australian and New Zealand Journal of Obstetrics and Gynecology published by F.J. Vajda and a team of researchers at University of Melbourne (Australia).  In their piece, titled “The prescribing of antiepileptic drugs for pregnant Australian women.” Vajda et al. explore further the risks of prenatal exposure to  antiepileptic drugs (AEDs) containing sodium valproate, such as Depacon, Depakene, and Depakote (Abbott Laboratories, Inc.).

This peer-reviewed article opens by plainly stating “It is not clear how widely it is appreciated in Australia that certain antiepileptic drugs, particularly valproate, are teratogenic.”  (To be clear, “teratogenic” means birth defect-causing.)

Analyzing data from the Australian Register of Antiepileptic Drugs, the team aimed to “assess trends in the pattern of antiepileptic drug prescribing for pregnant women in Australia to determine whether drug use is optimal, particularly from the fetal viewpoint.”

After statistical analysis, the team was able to determine that “Valproate was the only significant teratogen among the antiepileptic drugs in common use. There was a fetal malformation rate of 14.5% associated with its use in monotherapy, as compared with a rate of 3.15% in antiepileptic drug-unexposed pregnancies in women with epilepsy (OR = 5.23, 95% CI = 1.81, 15.09).” (emphasis added)

This means that if a child was exposed to Depakote or another valproate-containing AED in utero, the risk for birth defects was more than 5 times higher than that of children unexposed.

Vajda et al. (2012) continue: “Neurologists had progressively prescribed valproate less frequently and in lower dosage than other classes of practitioner over the 10-year study period, with a parallel decrease in occurrence of fetal malformations in pregnancies referred to the Register. Other prescribers of valproate did not seem to have adopted these practices to the same extent and had not obtained similar degrees of reduction in the occurrence of fetal malformations.” (emphasis added)

Because Abbott Laboratories failed time and again to highlight the risk for birth defects on drug warning labels, thousands of Depacon birth defect lawsuits have been filed in recent years.

If you or a loved one used Depacon, Depakote, or Depakene during pregnancy and your child was born with a congenital malformation, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Depacon birth defect lawyers at the information provided below.  We have the compassion, experience, and resources required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5528

justinian@dangerousdrugs.us

Our Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.

JAMA: Autism risk 500% increased with Depakote, Depakene, and Depacon in utero

Posted in Depacon / Depakene / Depakote

In the April, 2013 edition of JAMA, an article titled “Prenatal valproate exposure and risk of autism spectrum disorders and childhood autism.” from a Danish team led by J. Christensen evaluated the risks of prenatal exposure to the antiepileptic Depacon.  Because Abbott Laboratories, the manufacturer of this drug, failed time and again to warn of the risk for birth defects, autism, and other negative consequences of Depacon exposure, class-action Depacon lawsuits around the world

For clarity, the active chemical in Depacon (also Depakene and Depakote) is valproate.

The team states “Valproate is used for the treatment of epilepsy and other neuropsychological disorders and may be the only treatment option for women of childbearing potential. However, prenatal exposure to valproate may increase the risk of autism.”

Studying “all children born alive in Denmark from 1996 to 2006,” Christensen et al. (2013) “analyzed the risks associated with all autism spectrum disorders as well as childhood autism.”

“Of 655,615 children born from 1996 through 2006, 5437 were identified with autism spectrum disorder, including 2067 with childhood autism. … The estimated absolute risk after 14 years of follow-up was 1.53% … for autism spectrum disorder and 0.48% … for childhood autism. Overall, the 508 children exposed to valproate had an absolute risk of 4.42% … for autism spectrum disorder (adjusted HR, 2.9 …) and an absolute risk of 2.50% … for childhood autism (adjusted HR, 5.2)”

This means that if a child was exposed to Depacon / Depakene / Depakote, the risk for autism was increased about 3- to 5-fold.

This study concluded “Maternal use of valproate during pregnancy was associated with a significantly increased risk of autism spectrum disorder and childhood autism in the offspring, even after adjusting for maternal epilepsy.”  (Maternal disease did not cause birth defects, the drugs did.)

Since so many women have used Depacon during pregnancy unaware of the risks for birth defects, thousands of Depacon birth defect lawsuits are currently being filed.

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

(855) 452 – 5528

justinian@dangerousdrugs.us

Our Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.

Birth defects at significantly higher rate with Depacon, Depakene

Posted in Depacon / Depakene / Depakote

Titled “Malformation risks of antiepileptic drugs in pregnancy: a prospective study from the UK Epilepsy and Pregnancy Register.”, an article by J. Morrow and a team from Belfast (UK) published in the February, 2006 edition of Journal of Neurology, Neurosurgery, and Psychiatry aimed to “assess the relative risk of major congenital malformation (MCM) from in utero exposure to antiepileptic drug (AEDs).”  In recent years, many teams have found that prenatal exposure to AEDs containing sodium valproate such as Depacon, Depakene, and Depakote, is linked to increased risk for heart defects, neurological birth defects, and developmental disorders such as Autism.

For this study, “data collected by the UK Epilepsy and Pregnancy Register were analyzed”, and in total, 3,607 mother-child pairs were studied.  Results showed that “The overall MCM rate for all AED exposed cases was 4.2% … The MCM rate was higher for polytherapy (6.0%) … than for monotherapy (3.7%) … The MCM rate for women with epilepsy who had not taken AEDs during pregnancy (n = 239) was 3.5% (1.8% to 6.8%).”

Importantly, the team found that “The MCM rate was greater for pregnancies exposed only to valproate (6.2% (95% CI, 4.6% to 8.2%) than only to carbamazepine (2.2% (1.4% to 3.4%) (OR = 2.78 (p<0.001); adjusted OR = 2.97 (p<0.001))” and “Polytherapy combinations containing valproate carried a higher risk of MCM than combinations not containing valproate (OR = 2.49 (1.31 to 4.70)).”  This means that the risk for birth defects with valproate exposure was higher than for other drugs.

The team concluding that “Polytherapy regimens containing valproate had significantly more MCMs than those not containing valproate,” this article can be used in a Depacon birth defect lawsuit to demonstrate to court that the manufacturers of these drugs knew, or should have known, the risks associated with their product but failed to act.

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

(855) 452 – 5528

justinian@dangerousdrugs.us

Our Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.

 

2014 – Increased risk for birth defects seen with Depakote exposure

Posted in Depacon / Depakene / Depakote

In July, 2014, a team of Norwegian researchers led by K.O. Nakken published an article in Tidsskr Nor Laegeforen titled “Antiepileptic drugs and congenital malformations”, evaluating the consequences of prenatal exposure to epilepsy drugs containing sodium valproate, such as Depacon, Depakene, and Depakote (Abbott Laboratories, Inc.).  To-date, dozens of studies have demonstrated that a dramatically-increased risk for birth defects is linked to gestational exposure to these drugs.

Nakken et al. (2014) write “In pregnant women with epilepsy the use of antiepileptic drugs may increase the risk of harming the foetus. … The aim of this study was to assess the prevalence and type of congenital malformations in children exposed to antiepileptic drugs during pregnancy.”

In all, 813 pregnant women with epilepsy were studied.  “The women had three check-ups during the pregnancy, and the children were followed up twice during their first year of life.”

Results showed “a total of 34 congenital malformations in the children, of which 12 were heart defects, yielding a malformation rate of 4.5 %. Six of the malformations (18 %) were detected prenatally, 20 (59 %) were reported immediately after birth, and eight (24 %) were discovered during the child’s first year of life.”

Due to the fact that Abbott has failed time and again to sufficiently warn women of these and other risks, thousands of Depacon birth defect lawsuits have been filed around the world.

If you or a loved one used Depacon, Depakote, or Depakene during pregnancy and your child was born with a congenital malformation or had perinatal complications, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Depacon birth defect lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5528

justinian@dangerousdrugs.us

Our Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.

2008 – Epilepsy drugs with valproate linked to higher risk of birth defects, low IQ

Posted in Depacon / Depakene / Depakote

From Stockholm, Sweden, a 2008 piece titled “Teratogenic effects of antiepileptic drugs.” and appearing in the medical journal, Seizure, by T. Tomson et al. yet again demonstrates the postnatal risks of prenatal exposure to epilepsy drugs containing sodium valproate such as Depakote, Depakene, and Depacon (Abbott Laboratories, Inc.).

Here, it is stated that “The use of older generation antiepileptic drugs (AEDs) during pregnancy is known to be associated with a two- to threefold increased risk of birth defects in the offspring and possible also other adverse outcomes in the exposed infant”, warning that “Much less has been known about newer generation AEDs in this respect.”  To be clear, valproate is considered “second-” or “newer-generation.”

Because “Recent studies based on national registries as well as specific epilepsy and pregnancy registries are beginning to provide information on comparative teratogenic effects of different AEDs”, the team purports that “the prevalence of birth defects appears to be higher with exposure to valproate compared with carbamazepine and possibly also in comparison with lamotrigine.” (emphasis added)

And, states Tomson, “Retrospective and a few small prospective studies suggest that exposure to valproate also might be associated with a lower verbal IQ at school age”, calling for further research.

Because these drugs have been known by the medical community to cause birth defects for so long, Depakote birth defect lawsuits have been filed in great number across the country and around the world.  If you or a loved one used Depacon, Depakote, or Depakene when pregnant and your child was born with a congenital malformation, your family may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Depacon birth defect lawyers at the information provided below.  We have the compassion, resources, and experience required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5528

justinian@dangerousdrugs.us

Our Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.