July 2014

In a 2003 edition of Epilepsia, a piece titled “Clinical care of pregnant women with epilepsy: neural tube defects and folic acid supplementation.” by M.S. Yerby and a team from North Pacific Epilepsy Research in Portland, Oregon demonstrated that a child’s in utero exposure to maternal antiepileptic drugs (particularly those containing valproate – Depakote, Depakene, Depacon; Abbott Laboratories, Inc.) is linked to a range of serious birth defects.

The team states, “Women with epilepsy (WWE) have a risk of bearing children with congenital malformations that is approximately twice that of the general population. Most antiepileptic drugs (AEDs) have been associated with such risk. Valproate and carbamazepine have been associated specifically with the development of neural tube defects (NTDs), especially spina bifida.” (emphasis added).

Because Abbott Laboratories, a major manufacturer of drugs containing valproate has failed time and again to adequately warn women of these and other serious risks, 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 such as spina bifida, your family may be entitled to significant financial compensation from the manufacturer.  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.

A piece by medical researchers led by F.J. Vajda published in Acta Neurol Scand. (October, 2013), titled “Associations between particular types of fetal malformation and antiepileptic drug exposure in utero.” lives up to its title and provides more insight into the link between in utero exposure to epilepsy medication (Depacon, Depakene, and Depakote by Abbott Laboratories, Inc.) and birth defects.  To be clear, valproate is the active chemical in the drugs listed above.

Aiming to “study associations between patterns of fetal malformation and individual antiepileptic drugs taken during pregnancy”, this team analyzed data “relating to 1733 fetuses from 1703 pregnancies (147 of which were not exposed to antiepileptic drugs during pregnancy).”

Results showed that “There were statistically significant (P < 0.05) associations between (i) valproate exposure and spina bifida, malformations of the heart and great vessels, digits, skull bones, and brain, but not hypospadias, cleft palate/lip and mouth abnormalities, (ii) topiramate exposure and hypospadias and brain maldevelopments, and (iii) carbamazepine (CBZ) exposure and renal tract abnormalities.”

“The valproate findings are mostly in keeping with the published literature, but the topiramate finding regarding hypospadias and the association between CBZ exposure and various renal tract abnormalities raise questions of organ specific teratogenesis. More extensive data are desirable, particularly in relation to topiramate, which is being used increasingly as a migraine prophylactic in women of childbearing potential.”

Because this research linked such a wide range of serious birth defects with Depakote, Depakene, and Depacon exposure, this article can be used in a Depacon birth defect lawsuit.  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 from Abbott Laboratories.

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.

Appearing in the July-August, 2009 edition of the Spanish medical journal, Neurologia, a piece titled “Malformations and fetal death in the Spanish antiepileptic drug and pregnancy registry: results at 6 years” by M. Martinez Ferri et al. aimed to “study the incidence of major congenital malformations (MCM) /and/or fetal-perinatal death (MFP) and determine his relationship to AEDs in the Spanish EURAP registry.”  Over the last two decades, dozens of studies have shown that prenatal exposure to antiepileptic drugs containing sodium valproate (the active ingredient in Depacon, Depakene, and Depakote) is linked to increased risk for a range of serious birth defects.

In this study, “After informed consent, patients were included in the prospective Registry and evaluated: at the beginning, at the end of the second and third trimester, after delivery and one year after birth. A variety of variables were collected: demographic, type of epilepsy, frequency of seizures during pregnancy, AEDs and dose, potential toxics, folate use and dose, obstetric complications and information of the newborn. After 6 years of recruitment (June 2001-October 2007) we analyzed the results of this Registry in Spain with special attention on the incidence of major congenital malformations and foetal-perinatal death.”

The team states “Of a whole of 540 cases included in the Registry, 490 were prospective (included before the 16th week), of these we had complete information in 368 cases. Major congenital maLformations were present in 5% (n=13) of the child exposed to monotherapy and 12% (n=6) of those exposed to polytherapy (p=0.08). All polytherapy combinations with MCM, contained valproate.”

“The percentage of MCM was superior for valproate, particularly at doses equal or superior of 1000 mg/day (16%), although differences were not statistically significant. The majority of ours patients were on monotherapy (83%) with AEDs at low doses and were taking 5 mg of folate.”

Concluding that “Patients on polytherapy, particularly those with valproate in combination present more risk of MCM”, “For monotherapy exposures only weight at birth and the AEDs used have association statistically significant with MC/MFP”, and “Valproate in our series presents more risk than lamotrigine and does not show differences with regard to carbamazepine”, this article can be used in a Depacon birth defect lawsuit to demonstrate to a court that the manufacturers of these drugs knew, or should have known the risks of Depacon and failed to act.

If you or a loved one used Depacon, Depakote, or Depakene in 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 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 April, 2002, a team of medical researchers from Aberdeen (UK) led by J.C. Dean published a study titled “Long term health and neurodevelopment in children exposed to antiepileptic drugs before birth.” in Journal of Medical Genetics investigating the link between neonatal and later childhood morbidity “in children exposed to antiepileptic drugs [AEDs] in utero.”  To-date, many studies have demonstrated that prenatal exposure to AEDs like Depacon, Depakene, and Depakote is linked to an increased risk for birth defects.

The team states “Mothers taking antiepileptic drugs in pregnancy between 1976 and 2000 were ascertained from hospital obstetric records and 149 (58% of those eligible) took part. They had 293 children whose health and neurodevelopment were assessed.”

After standard statistical analyses, “Neonatal withdrawal was seen in 20% of those exposed to antiepileptic drugs. Congenital malformations occurred in 14% of exposed pregnancies, compared with 5% of non-exposed sibs, and developmental delay in 24% of exposed children, compared with 11% of non-exposed sibs.”  This shows a dramatically increased risk for birth defects, developmental delay, and neonatal withdrawal for children exposed to AEDs in utero.

Dean et al. (2002) also write that “After excluding cases with a family history of developmental delay, 19% of exposed children and 3% of non-exposed sibs had developmental delay, 31% of exposed children had either major malformations or developmental delay, 52% of exposed children had facial dysmorphism compared with 25% of those not exposed, 31% of exposed children had childhood medical problems (13% of non-exposed sibs), and 20% had behaviour disorders (5% of non-exposed).” (emphasis added)

Concluding that “Prenatal antiepileptic drug exposure in the setting of maternal epilepsy is associated with developmental delay and later childhood morbidity in addition to congenital malformation”, this study can be used as evidence in a Depacon birth defect lawsuit to demonstrate that AED manufacturers knew, or should have known that their products are linked to birth defects.  Because these manufacturers failed to notify women of these risks, 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.

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.

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.

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.

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.

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.

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.