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.

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.

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.

Titled “Major malformations in infants exposed to antiepileptic drugs in utero, with emphasis on carbamazepine and valproic acid: a nation-wide, population-based register study.”, a study by K. Wide et al. (2004) further demonstrates knowledge in the medical community that in utero exposure to antiepileptic drugs (AEDs) containing valproate (Depacon, Depakene, Depakote, and others) is linked to birth defects.  This article was published in the February, 2004 edition of Acta Paediatrica.

[Click here to read an FDA warning on the risks of AED therapy in pregnancy]

This team writes that “Antiepileptic drugs (AEDs) are known teratogens. Some specificity between different AEDs has been noted in the literature. The aim [of this present study] was to compare the teratogenic effect of valproic acid (VPA) and carbamazepine (CBZ) in monotherapy.”

In all, about 1,400 babies with prenatal AED exposure were studied, and neonatal outcomes were compared to other babies born in the same period, numbering about 580,000 (Sweden).

Wide (2004): “The odds ratio (OR) for having a malformation in the AED exposed group was 1.86 [95% confidence interval (95% CI) 1.42-2.44]. Exposure to VPA in monotherapy compared with CBZ in monotherapy gave OR = 2.51 (95% CI 1.43-4.68) for a neonatal diagnosis of malformations.”

This means that babies with AED exposure were 86% more likely to be born with a birth defect, and that valproate was 250% more likely to cause malformations than carbamazepine.

Since so many women have used these drugs in pregnancy unaware of the increased risk for serious birth defects (due to a manufacturer’s failure to warn), 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 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, 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.

Published in a 1999 edition of Annals of Neurology, an article by E.B. Samrén et al. titled “Antiepileptic drug regimens and major congenital abnormalities in the offspring.” provides important insight into the risks of prenatal exposure to antiepileptic drugs (AEDs), something that has been demonstrated to greatly increase the rate of spina bifida, other neurological birth defects, autism, and heart defects.  To be sure, this connection is mainly seen with drugs containing sodium valproate such as Depakote, Depakene, and Depacon (Abbott Laboratories, Inc.).

Samrén et al. (1999) write that “To assess the risk of major congenital abnormalities associated with specific antiepileptic drug regimens, a large retrospective cohort study was performed. The study comprised 1,411 children born between 1972 and 1992 in four provinces in The Netherlands who were born to mothers with epilepsy and using antiepileptic drugs during the first trimester of pregnancy, and 2,000 nonepileptic matched controls.”

We found significantly increased risks of major congenital abnormalities for carbamazepine and valproate monotherapy, with evidence for a significant dose-response relationship for valproate. …

This study shows that most antiepileptic drug regimens were associated with an increased risk of major congenital abnormalities in the offspring, in particular valproate (dose-response relationship) and carbamazepine monotherapy, benzodiazepines in polytherapy, and caffeine comedication in combinations with phenobarbital.” (emphasis added)

Due to the fact that Abbott Laboratories did not warn women of these risks, Depacon birth defect lawsuits have been filed in great number around the world.  As such, if you or a loved one used Depacon, Depakote, or Depakene while pregnant 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.

Over the past ten years or so, dozens of studies have been published linking prenatal exposure to the antiepileptic drugs Depacon, Depakene, and Depakote (Abbott Laboratories, Inc.) with birth defects.  Here, I will summarize one such study, published by R. Banach and a team from McMaster University in Ontario Canada.  This study was titled “Long-term developmental outcome of children of women with epilepsy, unexposed or exposed prenatally to antiepileptic drugs: a meta-analysis of cohort studies.” and appeared in the January, 2010 edition of Drug Safety.

Aiming to “estimate intellectual development of children prenatally exposed or unexposed to AEDs,” the team conducted a literature search” to “identify all original cohort studies that investigated cognitive functioning after in utero exposure to AEDs.”  (“AEDs” stands for antiepileptic drugs.)

In all, “Eight studies (three for valproic acid and five for carbamazepine) evaluated IQ as a measure of cognitive development,” though one was dropped because it appeared in two publications.  The team states: “In total, the seven selected studies included 67 children exposed in utero to valproic acid and 151 exposed to carbamazepine, and 494 unexposed controls born to healthy women or to women with untreated epilepsy.”

Finding that “The mean full-scale IQ (FSIQ), verbal IQ (VIQ) and performance IQ (PIQ) scores in children exposed to valproic acid in utero were 83.9 (95% CI 64.2, 103.6), 93.7 (95% CI 72.6, 114.7) and 88.3 (95% CI 69.9, 106.9), respectively” while “The mean FSIQ, VIQ and PIQ scores in the control group were 102 (95% CI 90, 116), 101 (95% CI 87, 114) and 99 (95% CI 90, 117), respectively” it was determined that prenatal exposure to drugs containing valproate hinders cognitive development.

Accordingly, it was concluded that “Exposure to valproic acid in pregnancy is associated with significantly reduced intelligence in children whose mothers were treated for epilepsy. … Clinicians should inform families of the potential cognitive adverse effects of valproic acid.” (emphasis added)

Due to the fact that Abbott Laboratories knew the risks associated with its products but failed to adequately inform women, 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 faced adverse birth outcomes, 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.

Back in 1997, a team of Dutch medical researchers led by E.B. Samrén published an article titled “Maternal use of antiepileptic drugs and the risk of major congenital malformations: a joint European prospective study of human teratogenesis associated with maternal epilepsy.” in Epilepsia.  That article aimed to “To quantify the risks of intrauterine antiepileptic drug (AED) exposure in monotherapy and polytherapy.”  In the years that followed, dozens of research teams have linked prenatal exposure to valproate (Depacon, Depakene, Depakote) with a range of serious birth defects.

For this study, “Data from five prospective European studies totaling 1,379 children were pooled and reanalyzed.”  In all, “Data were available for 1,221 children exposed to AED during pregnancy and for 158 children of unexposed control pregnancies.”

Samrén writes that “Overall, when comparing a subgroup of 192 children exposed to AED with 158 children of matched nonepileptic controls, there was an increased risk of major congenital malformations (MCA) in children exposed to AED during gestation [relative risk (RR) 2.3; 95% confidence interval (CI): 1.2-4.7].”  This means that overall, children exposed to maternal epilepsy drugs were 2.3 times as likely to have birth defects compared to controls.

With respect to Depacon / Depakote / Depakene specifically, the team writes “A significant increase in risk was found for children exposed to valproate (VPA) (RR 4.9; 95% CI: 1.6-15.0) or carbamazepine (CBZ) (RR 4.9; 95% CI: 1.3-18.0) in monotherapy.”  (Children exposed to valproate in utero were about five times as likely to be born with a major malformation.)

It was also found that exposure to high doses of Depacon and other drugs containing valproate “were at a significantly increased risk of MCA, especially neural tube defects, compared to offspring exposed < or =600 mg VPA/day (RR 6.8; 95% CI: 1.4-32.7).”  That is, babies exposed to high-dose maternal Depacon were almost 7 times as likely to face birth defects than controls.

Because Abbott Laboratories, Inc., the manufacturer of these drugs, has failed time and again to adequately inform women of the increased risk for birth defects linked to Depacon, Depacon birth defect lawsuits have been filed in great number in recent 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 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.

From a team of Swedish researchers, an article appearing in the November, 2009 edition of Neurologic Clinics titled “Teratogenic effects of antiepileptic medications.” provides important insight into the connection between prenatal exposure to epilepsy drugs Depacon, Depakene, and Depakote and cardiovascular and neurological birth defects.  Because of a failure to warn, class-action Depacon lawsuits have been filed around the world.  This article was written by T. Tomson and D. Battino.

The study team states that “Data on clinical teratogenicity are at best derived from carefully conducted observational studies, whereas randomized, controlled trials have no place in this research area. … New relevant information has become available during the last 5 years on pregnancy outcomes with 3 of the most frequently used AEDs: carbamazepine, valproate, and lamotrigine.”  To be clear, valproate is the active chemical in Depacon, Depakene, and Depakote.

Malformation rates with valproate have consistently been found to be 2 to 3 times higher compared with carbamazepine or lamotrigine. More limited data also suggest adverse effects of high doses of valproate on cognitive development of the exposed child.” (emphasis added)

The team continues, stating that “Based on these observations, valproate should not be a first-line AED for women who are considering pregnancy. In this situation this drug is best avoided if other effective but safer AEDs can be found for each individual woman’s seizure disorder.”

As such, this article can be used in a Depacon birth defect lawsuit to demonstrate to a court that the manufacturer, Abbott Laboratories, knew or should have known the risks associated with its 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 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.

Titled “Cognitive function at 3 years of age after fetal exposure to antiepileptic drugs.”, an article by K.J. Meador and a team from Emory University published in the April, 2009 edition of New England Journal of Medicine provides further insight into the adverse effects of prenatal exposure to antiepileptic drugs containing valproate, the active chemical in Depacon, Depakene, and Depakote (Abbott Laboratories, Inc.)

Providing background, Meador states, “Fetal exposure of animals to antiepileptic drugs at doses lower than those required to produce congenital malformations can produce cognitive and behavioral abnormalities, but cognitive effects of fetal exposure of humans to antiepileptic drugs are uncertain.”

Studying 309 children exposed to either carbamazepine, lamotrigine, phenytoin, or valproate in utero, the team evaluated cognitive outcomes at three years of age.  Results showed that “At 3 years of age, children who had been exposed to valproate in utero had significantly lower IQ scores than those who had been exposed to other antiepileptic drugs.”

“On average, children exposed to valproate had an IQ score 9 points lower than the score of those exposed to lamotrigine (95% confidence interval [CI], 3.1 to 14.6; P=0.009), 7 points lower than the score of those exposed to phenytoin (95% CI, 0.2 to 14.0; P=0.04), and 6 points lower than the score of those exposed to carbamazepine (95% CI, 0.6 to 12.0; P=0.04).”

It was also determined that “The association between valproate use and IQ was dose dependent”, meaning that if children were exposed to more valproate in pregnancy, IQ scores were lower.  Accordingly, the team’s conclusions were as follows: “In utero exposure to valproate, as compared with other commonly used antiepileptic drugs, is associated with an increased risk of impaired cognitive function at 3 years of age. This finding supports a recommendation that valproate not be used as a first-choice drug in women of childbearing potential.” (emphasis added)

Because Abbott Laboratories, Inc. has failed time and again to provide sufficient warning of adverse birth outcomes after prenatal Depacon exposure, Depacon birth defect lawsuits have been filed in great number around the world.

If you or a loved one used Depacon, Depakote, or Depakene and gave birth to a child with a birth defect or who had an otherwise poor birth outcome, 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.

In February of this year, E. Campbell and a team from Royal Victoria Hospital (Belfast, UK) published a piece in Journal of Neurology, Neurosurgery, and Psychiatry titled “Malformation risks of antiepileptic drug monotherapies in pregnancy: updated results from the UK and Ireland Epilepsy and Pregnancy Registers.” further demonstrating the link between exposure to maternal epilepsy drugs Depacon, Depakene, and Depakote and birth defects.

Plainly, the team states at the outset of this article’s abstract that “Antiepileptic drug (AED) exposure during pregnancy increases the risk of major congenital malformations (MCMs)”, explaining that this article will “provide updated results from the UK Epilepsy and Pregnancy Register of the risk of MCMs after monotherapy exposure to valproate, carbamazepine and lamotrigine” by way of a “Fifteen-year prospective observational study from 1996 until 2012.”  In all, 5,206 cases were studied, 1,290 of which were exposed to valproate, the active chemical in Depacon, Depakote, and Depakene.

The MCM risk with valproate monotherapy exposure in utero was 6.7% (95% CI 5.5% to 8.3%) compared with 2.6% with carbamazepine (95% CI 1.9% to 3.5%) and 2.3% with lamotrigine (95% CI 1.8% to 3.1%).”  (To be clear, “MCM” stands for major congenital malformation, or “birth defect.”)

As such, the team concluded that “In utero exposure to valproate carries a significantly higher MCM risk than lamotrigine (p=0.0001) and carbamazepine (p=0.0001) monotherapy. In contrast to prior findings, high-dose lamotrigine was associated with fewer MCMs than all doses of valproate.”

Since thousands of women have used Depacon, Depakene, and Depakote during pregnancy unaware of the increased risk for birth defects, Depacon birth defect lawsuits have been filed against the manufacturer (Abbott Laboratories, Inc.) 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, 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.