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Dangerous Drugs & Medical Devices

News & Commentary on Prescription Drug & Medical Device Lawsuits

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.

Depakote raises risk for birth defects 2- to 4-fold

Posted in Depacon / Depakene / Depakote

In recent years, dozens of studies have linked prenatal exposure to the antiepileptic drugs containing valproate (Depacon, Depakene, and Depakote) with birth defects including spina bifida, and developmental disorders such as Autism.  Since the manufacturer of these drugs, Abbott Laboratories, failed time and again to warn women of these risks, Depacon birth defect lawsuits have been filed in great number.  Here, I present a piece of medical research illustrating these risks.  This piece, titled, “Antiepileptic treatment in pregnant women: morphological and behavioural effects.”, was by T. Tomson, and appeared in a 2011 edition of Handbook of Experimental Pharmacology.

Quoting from the abstract, the team states “It is well established that children exposed to antiepileptic drugs (AEDs) in utero have an increased risk of adverse pregnancy outcomes including foetal growth retardation, major congenital malformations and impaired postnatal cognitive development.”

The prevalence of major malformations in children exposed to AEDs has ranged from 4 to 10%, 2-4 times higher than in the general population. More recent studies suggest a smaller increase in malformation rates.

Malformation rates have consistently been higher in association with exposure to valproate than with carbamazepine and lamotrigine. Some prospective cohort studies also indicate reduced cognitive outcome in children exposed to valproate compared to carbamazepine and possibly lamotrigine.” (emphasis added)

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 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.

Huge increase in birth defect risk with prenatal Depacon, AED exposure

Posted in Depacon / Depakene / Depakote

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.

Offspring maladaptive with in utero SSRI epxosure

Posted in SSRI Birth Defects

Today, looking through PubMed Health, a medical literature database curated by the United States National Library of Medicine and The National Institutes of Health, I found another article linking poor neonatal outcomes and  to birth defects prenatal exposure to maternal selective serotonin reuptake inhibitor drugs (SSRIs).  This article, titled “Developmental effects of SSRIs: lessons learned from animal studies.” was by X. Borue et al. and appeared in the October, 2007 edition of International Journal of Developmental Neuroscience.

Noting that “SSRIs may be passed to the fetus through the placenta and the neonate through breastfeeding, potentially exposing them to SSRIs during peri- and postnatal development”, this team aimed to “assess the current research done in animals that sheds light on the role of serotonin during development and the possible effects of SSRIs.”

Results of their analysis illustrated that “Experimental studies in rodents show that administration of SSRIs during a key developmental window creates changes in brain circuitry and maladaptive behaviors that persist into adulthood.” (emphasis added)

Because the manufacturer of many SSRI drugs like Prozac, Paxil, and Zoloft have failed time and again to adequately inform women of these and other serious risks, SSRI birth defect lawsuits have been filed around the world 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.

2003 – In Utero AED Exposure Linked to Birth Defects Far Above Background Rate

Posted in Depacon / Depakene / Depakote

In September, 2003, a team from St. Vincent’s Hospital (Melbourne, Australia) published a piece in Journal of Clinical Neuroscience titled “The Australian registry of anti-epileptic drugs in pregnancy: experience after 30 months.”  That article, by F.J. Vajda et al., further explored the risks of prenatal exposure to antiepileptic drugs containing valproate, such as Depacon, Depakene, and Depakote by Abbott Laboratories.  To-date, dozens of research teams have linked valproate to birth defects, prompting sharp warnings from the United States FDA.

Vajda states “Most women with epilepsy need to take antiepileptic drugs (AEDs) in pregnancy to prevent the potentially harmful effects of seizures. Retrospective studies have demonstrated an increased chance of having a child with a birth defect (BD) in women with epilepsy taking AEDs. It is uncertain how much of this risk is directly caused by the AEDs and whether certain drugs or combinations are associated with a greater risk.”

This study was an “An Australia-wide, prospective, voluntary, telephone-interview based, observational register” in which “Three groups of pregnant women were enrolled: those with epilepsy taking AEDs, those with epilepsy not taking AEDs, and those taking AEDs for a non-epileptic indication.”

In all 334 women were studied from all Australian states and territories.  “Two hundred and ninety two pregnancies had been completed, of which 256 (88%) resulted in a healthy live birth, 19 (6.5%) a live birth with a birth defect, four an induced abortion because of a detected malformation on ultrasound, one premature labour with a stillbirth and 12 (4%) spontaneous abortions.”

The team found that “the incidence of birth defects in relation to specific AEDs was: valproate (16.7%)”, far higher than the background rate for congenital malformations.

Because the manufacturer of these drugs has failed time and again to warn women of these and other serious risks, thousands of Depacon birth defect lawsuits are currently being filed.

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.

1999 – Researchers find Depacon, Depakene, and Depakote linked to major congenital abnormalities

Posted in Depacon / Depakene / Depakote

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.