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Dangerous Drugs & Medical Devices

News & Commentary on Prescription Drug & Medical Device Lawsuits

Depakote, other AEDs again linked to birth defects

Posted in Depacon / Depakene / Depakote

An article appearing in the May, 2010 edition of Epilepsia titled “The teratogenic risk of antiepileptic drug polytherapy.” by F.J. Vajda and a team from Royal Melbourne Hospital and University of  Melbourne (Australia) further explores the connection between antiepileptic drugs containing sodium valproate such as Depacon, Depakene, and Depakote and increased risk for congenital malformations.

For this study the team performed a “Statistical analysis of malformation rate and antiepileptic drug exposure data from the Australian Register of Antiepileptic Drugs in Pregnancy, and from [medical] literature.”

Results showed that “The calculated relative risk (RR) value for AED polytherapy compared with monotherapy was below 1.0 in only 3 of 14 literature publications. In the register, at 1 year postnatally there were fetal malformations in 5.32% of 282 AED polytherapy pregnancies, and in 7.84% of 791 AED monotherapy pregnancies, an RR of 0.68 [95% confidence interval (CI) 0.39-1.17). For pregnancies exposed to valproate, the RR of fetal malformation (0.39, 95% CI 0.20-0.89) was lower in polytherapy (7.26%) than in monotherapy (17.9%); the difference did not depend on valproate dosage. The RR values for fetal malformation were not significantly different for AED polytherapy and monotherapy when valproate was not involved. Logistic regression suggested that coadministration of lamotrigine may have reduced the malformation risk from valproate.”

What all this means is that exposure to drugs containing valproate increased risk for birth defects compared to other antiepileptic treatments.  As such, the team concluded that patients should add the drug lamotrigine and not use only valproate during pregnancy.

Because the manufacturer of these drugs, Abbott Laboratories, has failed time and again to warn women of these and other serious risks linked to prenatal valproate exposure, Depacon birth defect lawsuits are currently being 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.

2011 – Depacon, Depakene, Depakote exposure linked to poor language skills

Posted in Depacon / Depakene / Depakote

In February, 2011, C. Nadebaum and a British research team published a piece in Neurology titled “Language skills of school-aged children prenatally exposed to antiepileptic drugs.” that provides important insight into the connection between antiepileptic drugs containing sodium valproate (Depacon, Depakene, and Depakote) and birth defects.

Nadebaum et al. (2011) state “Fetal exposure to some antiepileptic drugs (AEDs) carries increased risk of major birth defects, and may be associated with reduced intellectual abilities. The impact on language remains unclear. This study aimed to investigate the impact of fetal AED exposure on language skills.”

Studying language skills of “102 AED-exposed children” and comparing results to a control group, the team found that “Mean CELF-4 Core Language scores of children exposed to sodium valproate in monotherapy (mean 91.5, SD 17.5) or polytherapy (mean 73.4, SD = 22.3) were significantly below the standardized test mean of 100 (p < 0.05).”  This means that babies with Depacon exposure had significantly lower language skill later in life.

The team also found that babies exposed to several other antiepileptic drugs had normal language skills.  And, “First-trimester sodium valproate dose was negatively correlated with language scores, and significantly predicted language scores after controlling for other group differences.”

Because Abbott Laboratories, the company that makes Depacon, Depakene, and Depakote, has failed to warn women of the risk for birth defects, Depacon birth defect lawsuits have been filed in great number over the last several years.

If you or a loved one used Depacon, Depakote, or Depakene during pregnancy and your child was born with a birth defect, 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.

1992 – Study links Depakote and birth defects

Posted in Depacon / Depakene / Depakote

Back in 1992, a French research team led by C. Dravet published a piece in Neurology titled “Epilepsy, antiepileptic drugs, and malformations in children of women with epilepsy: a French prospective cohort study.” that illuminated risks of prenatal exposure to anti-seizure drugs Depacon, Depakene, and Depakote (Abbott Laboratories).  Since, the US FDA has warned of Depacon use during pregnancy and negative fetal outcomes.

Here is the abstract for that article:

“We conducted a prospective study of teratogenic effects of antiepileptic drugs (AEDs) in pregnant women with epilepsy in southeast France, comparing malformation rates with those collected by a birth defects registry. We evaluated isolated microcephalies separately. Malformations were seen in 7% of infants of mothers with epilepsy (IME) and in 1.36% of the general population. No significant relationship was found between type and severity of epilepsy and occurrence of malformations or isolated microcephaly. Valproate and phenytoin were the most teratogenic (all malformations). None of the malformations observed in IME whose mothers received valproate, phenytoin, or phenobarbital was seen in IME not exposed to the respective AEDs. [emphasis added] Phenytoin plus phenobarbital was more teratogenic than phenobarbital alone. Benzodiazepines, prescribed only in combinations, had a borderline, nonspecific effect on microcephaly.”

To be clear, the active chemical in Depacon, Depakote, and Depakene is valproate.  This team found that valproate was the most likely to cause birth defects, and that none of the birth defects seen in babies with prenatal valproate exposure were seen in babies without prenatal exposure to maternal antiepileptic drugs.

Because Abbott has failed to adequately warn women of the risk for birth defects, Depacon birth defect lawsuits are currently being filed in great number.

If you or a loved one used Depacon, Depakote, or Depakene during pregnancy and your child was born with a birth defect, 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, 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.

Autism, developmental delay risk raised 300% with SSRI exposure before birth

Posted in SSRI Birth Defects

This past April, a piece by R.A. Harrington and a team from Johns Hopkins Bloomberg School of Public Health published in Pediatrics titled “Prenatal SSRI Use and Offspring With Autism Spectrum Disorder or Developmental Delay.” further illustrates the link between prenatal exposure to selective serotonin reuptake inhibitor drugs (SSRIs) and increased risk for autism and congenital malformations including heart defects, neurological birth defects, and other adverse birth outcomes.

The objective of this article was to “examine associations between prenatal use of selective serotonin reuptake inhibitors (SSRIs) and the odds of autism spectrum disorders (ASDs) and other developmental delays (DDs).”

In all, 966 children with either autism (492), developmental delay (154), or normal development (also called “typical development,” or TD) (320) were studied.  Results showed that “overall, prevalence of prenatal SSRI exposure was lowest in TD children (3.4%) but did not differ significantly from ASD (5.9%) or DD (5.2%) children.”  This shows that a higher percent of children who have autism or developmental delay were exposed to SSRIs before birth.

The team also found that “Among boys, prenatal SSRI exposure was nearly 3 times as likely in children with ASD relative to TD (adjusted odds ratio [OR]: 2.91; 95% confidence interval [CI]: 1.07-7.93); the strongest association occurred with first-trimester exposure (OR: 3.22; 95% CI: 1.17-8.84).”  Autistic boys were about three times as likely to have prenatal SSRI exposure.  The same was true for boys with developmental delay.

As such, the team concluded that “In boys, prenatal exposure to SSRIs may increase susceptibility to ASD or DD.”  Because a number of women have used SSRIs in pregnancy unaware of these and other serious risks, SSRI birth defect lawsuits are currently being filed all over 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 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.

Study finds some babies more likely to have SSRI birth defects than others

Posted in SSRI Birth Defects

Last summer, Developmental Psychobiology published a piece by S. Brummelte and a team from University of British Columbia (Vancouver) titled “Antidepressant use during pregnancy and serotonin transporter genotype (SLC6A4) affect newborn serum reelin levels.” exploring contributing genetic factors to susceptibility for SSRI-induced birth defects.  To-date, a number of studies have shown that in utero exposure to selective serotonin reuptake inhibitor drugs (SSRIs) like Prozac, Paxil, and Zoloft is linked to birth defects, but this paper presents the idea that babies with certain genetic profiles are more likely to have birth defects, given prenatal SSRI exposure.

The team states, “This study was undertaken to determine whether altered early serotonin signaling either via gestational serotonin reuptake inhibitor (SRI) exposure or genetic variations in the serotonin transporter promoter region (SLC6A4) alters levels of reelin, an important glycoprotein in neurodevelopment, in mothers and their neonates.”

In this study, “Serum reelin protein expression was quantified by immunoblot from maternal and neonatal blood collected at delivery from women taking either an SRI during gestation or controls. SRI-exposed mothers had higher levels of one reelin fragment, while SRI-exposed neonates had lower total reelin levels, particularly in females and reelin levels differed with SLC6A4 genotype. Lower neonatal reelin levels predicted less time spent sleeping and more irritability during neonatal behavioral assessment on Day 6 of life.” (emphasis added)

Brummelte concluded that the “results suggest that prenatal SRI exposure and the SLC6A4 genotype influences reelin protein expression in both the mother and newborn and that this may be reflected in neonatal behavior.” (emphasis added)

Due to the fact that SSRI manufacturers have failed time and again to warn women of these and other serious risks, SSRI birth defect lawsuits have been filed by the thousands.

If you or a loved one used SSRIs and gave birth to a child with a birth defect, 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.

2005 – Higher rate of birth defects with Depacon in pregnancy

Posted in Depacon / Depakene / Depakote

A 2005 article in Acta Neurologica Scandinavica by F.J. Vajda and a team from University of Melbourne (Australia) titled “Maternal valproate dosage and foetal malformations.” further elucidates the connection between prenatal exposure to antiepileptic drugs like Depacon and birth defects.  Because the manufacturers (Abbott Laboratories) failed to warn women of this risk in light of warnings from the U.S.FDA, class-action Depacon lawsuits have been filed around the world.

Here, Vajda et al. (2005) aimed to “study the possible dose dependence of the foetal malformation rate after exposure to sodium valproate in pregnancy.”  To be clear, sodium valproate is the active chemical in Depacon, Depakene, and Depakote.

Studying “records of all foetuses in the Australian Registry of Antiepileptic Drugs in Pregnancy exposed to valproate, to carbamazepine, lamotrigine or phenytoin in the absence of valproate, and to no antiepileptic drugs”, the team found that “The foetal malformation rate was higher (P<0.05) in the 110 foetuses exposed to valproate alone (17.1%) …  than in the 297 exposed to the other drugs without valproate (2.4%). It was also higher (P<0.10) than in the 40 not exposed to antiepileptic drugs (2.5%).”

It was also found that “the malformation rate in those exposed to valproate increased with increasing maternal drug dosage,” meaning that the more Depacon a women took in pregnancy, for example, the higher the likelihood that her child be born with a congenital malformation.

Concluding, “Foetal exposure to valproate during pregnancy is associated with particularly high, and dose-dependent risks of malformation compared with other antiepileptic drugs, and may possibly involve different teratogenetic mechanisms”, this article can be used in a Depacon birth defect lawsuit to demonstrate to court that Abbott knew, or should have known, that Depacon (also Depakene and Depakote) are linked to birth defects.

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.

Depacon Doubles Risk for Birth Defects (At Least)

Posted in Depacon / Depakene / Depakote

Another article demonstrating that prenatal exposure to antiepileptic drugs containing valproate like Depacon is associated with birth defects, “Valproate and the risk for congenital malformations: Is formulation and dosage regime important?” was published in the April, 2012 edition of the medical journal Seizure by E. Mawhinney et al. of Belfast, UK.

In light of warnings to this effect by the United States FDA, the manufacturer of Depacon (also Depakote, Depakene) – Abbott Laboratories, Inc. – failed to warn women of these risks, prompting class-action Depacon lawsuits worldwide.

Plainly, the team states in the “Background” section of their piece, “Use of valproate in pregnancy, especially in doses over 1000mg a day, is known to be associated with a higher risk for major congenital malformations compared with other antiepileptic drugs.”

Using the UK Epilepsy and Pregnancy Register, the team studied “Outcome data … for 1109 pregnancies exposed to valproate in monotherapy. Exposure to 1000mg a day or more of valproate was associated with almost double the risk of major congenital malformation compared with daily valproate doses below 1000mg daily (8.86% vs 4.88%, RR: 1.7; 95% CI: 1.1-2.9).”

Concluding that “Prescribing controlled release valproate or multiple daily administrations in pregnancy did not reduce the risk for malformations” and “Higher malformation rates observed with in utero exposure to valproate are more likely related to total daily dose, rather than peak serum levels”, this article can be used in a Depacon birth defect lawsuit to demonstrate to a court that Abbott Laboratories knew, or should have known, the risks associated with its products.

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, 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.

2- to 3-fold increase in birth defects linked to Depacon / Depakote / Depakene

Posted in Depacon / Depakene / Depakote

In 2005, a team of researchers from The University of Pavia (Pavia, Italy) published a study in Lancet Neurology titled “Birth defects after prenatal exposure to antiepileptic drugs.”, yet again demonstrating that in utero exposure to Depacon, Depakene, and Depakote (antiepileptic drugs containing valproate) is linked to an increased risk for spina bifida, other neurological birth defects, autism, and heart defects.

The team behind this study, led by Perucca, writes “Exposure to antiepileptic drugs (AEDs) in the first trimester of pregnancy has been associated with an increased risk of major congenital anomalies (MCAs) in offspring.”

At this time few large studies had been conducted regarding the link between AEDs and MCAs, and this troubled Perucca et al. Soon, “Several larger-scale studies, including collaborative multinational registries, [were] set up to compare MCA risks associated with different treatments, including newer generation AEDs [and results] have largely been consistent with the notion that monotherapy with the most commonly used AEDs is associated with an increase in risk of MCAs by two to three times, and that the magnitude of risk increases in offspring exposed to polytherapy.”  (Exposure to AEDs raises the risk for birth defects 2- or 3-fold.)

Importantly, the team states that “Available evidence does not suggest that epilepsy per se is associated with a major increase in the risk of MCAs”, meaning that maternal epilepsy does not cause malformations – drugs do.

Perucca continues, “Almost all studies have suggested that exposure to valproic acid is associated with a greater incidence of MCAs than other AEDs. Valproic acid is also the only AED for which a dose-dependency has been confirmed in several studies: the increase in risk of MCAs, compared with other AEDs, is especially evident at doses above 800-1000 mg/day.”

Since the manufacturer of Depacon, Depakene, and Depakote, Abbott Laboratories, Inc., knew their products were linked to birth defects and failed to adequately inform expectant mothers who used AEDs, 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 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.

2012 – Babies with Depakote exposure more likely to have malformations

Posted in Depacon / Depakene / Depakote

Published in the January, 2012 edition of Journal of Clinical Neuroscience, an article by F.J. Vajda titled “Teratogenicity of the newer antiepileptic drugs–the Australian experience.” provides important insight into the connection between valproate-containing antiepileptic drugs such as Depacon, Depakene, and Depakote (Abbott Laboratories) and birth defects including spina bifida and developmental disorders including Autism.

Reviewing data from the Australian Pregnancy Register, the team evaluated pregnancy outcomes for “1317 women with epilepsy (WWE)”

“The incidence of malformations associated with lamotrigine monotherapy was 12/231 (5.2%), with topiramate 1/31 (3.2%) and with levetiracetam 0/22 (0%). This compares with rates of 1/35 (2.9%) for phenytoin, 35/215 (16.3%) for valproate (VPA), 19/301 (6.3%) for carbamazepine and 6/116 (5.2%) for untreated women. There was no evidence of dose-dependent risks of foetal malformation, except with VPA monotherapy.”

This article could be used in a Depacon birth defect lawsuit to demonstrate to a court that Abbott knew, or should have known, the range of risks linked to their product and 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, 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 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.

Study links maternal SSRIs and childhood autism

Posted in SSRI Birth Defects

A New England Journal of Medicine article published in December, 2013 by A. Hviid et al. titled “Use of selective serotonin reuptake inhibitors during pregnancy and risk of autism.” demonstrates further the connection between prenatal exposure to a mother’s selective serotonin reuptake inhibitor drugs (SSRIs) and increased risk for congenital malformations and autism.

Hviid et al. (2013) provide background by stating, in part, that, “Studies have raised concern about an association between the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy and an increased risk of autism spectrum disorders in the offspring.”

Studying all (single) live births in Denmark (1996-2005) – over 625,000 in total, the team “linked information on maternal use of SSRIs before and during pregnancy, autism spectrum disorders diagnosed in the offspring, and a range of potential confounders.”

In all, “3892 cases of autism spectrum disorder” were identified in the general population “(incidence rate, 77.0 per 100,000 person-years)” and “52 cases” of autism were found in “offspring of women who were exposed to SSRIs during their pregnancy (incidence rate, 122.6 per 100,000 person-years).”

This team made two findings.  First, they found that “On the basis of the upper boundary of the confidence interval, our study could not rule out a relative risk up to 1.61, and therefore the association warrants further study,” meaning that it is possible the risk for autism is raised by 61% if a mother uses SSRIs in pregnancy.

Next, they found that “Among women who received SSRIs before pregnancy but not during pregnancy, the corresponding fully adjusted rate ratio was 1.46 (95% CI, 1.17 to 1.81).”  This means that if a woman used SSRIs before pregnancy, the risk for autism was (definitely) raised by 46%.

Because so many women have used SSRIs unaware of these risks, thousands of SSRI birth defect lawsuits and SSRI autism lawsuits are currently being filed.

If you or a loved one used SSRIs and gave birth to a child with a birth defect or who was diagnosed with autism, 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 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.