Search results for: spina bifida

Maternal use of antiepileptic drugs is well-known to be associated with elevated risks of major congenital malformations in offspring.  When compared to the general public, the risk for congenital malformations in the offspring of women on antiepileptic medication is roughly 4 to 6 percents, twice as likely as women not on AEDs.  Author Yerby MS from the Department of Obstetrics and Gynecology at Oregon Health & Science University, North Pacific Epilepsy Research Center in Portland, wrote an article called “Management issues for women with epilepsy: neural tube defects and folic acid supplementation”, where he states “a particular association of valproate and carbamazepine with neural tube defects (NTDs)–specifically, with spina bifida aperta (SB)–has been identified. The [overall] prevalence of SB is approximately 1 to 2% with valproate exposure and 0.5% with carbamazepine. Reported risk factors for NTDs include previous pregnancy with an NTD, maternal insulin-dependent diabetes mellitus, various nutritional deficiencies and occupational exposures, and high prepregnancy weight.”

One common side-effect of antiepileptic drugs is inhibiting the absorption rate of folic acid in the body. (Folic acid is a naturally occurring substance found in foods such spinach and sunflower seeds.) Yerby MS. further explains that “Deficiencies of folate have been implicated in the development of birth defects, including NTDs. The value of periconceptional folic acid supplementation for women in the general population is accepted. However, it is unclear whether folic acid supplementation protects against the embryotoxic and teratogenic effects of AEDs because animal and human studies and case reports have shown variable results.”  Despite some questions that still remain as to the effectiveness of a folic acid regiment, most doctors recommend epileptic women who are pregnant to stay on the regiment for the duration of their pregnancy.

One AED containing valproate found to be highly associated with an increased risk for birth defects is Depacon.  Depacon (also Depakene, Depakote) is manufactured by Abbott Laboratories, and it is the responsibility of that company to make clear to users any and all risks associated with its products.  Sadly, Abbott failed to make clear those risks and a number of women used Depacon during pregnancy, unaware of the risk for birth defects posed to their developing baby.

If you used Depacon during pregnancy and your child was born with a cogenital malformation, you may be entitled to significant financial compensation for the undue injury sustained by your child and family.  For a free, no-obligation case consultation, do not hesitate to contact our team of Depacon lawyers at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us

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

Spina Bifida (“myelomeningocele” being the most common form) is a birth defect in the larger class of “neural tube defects,” characterized by the malformation or underdevelopment of the neural tube in a developing infant before birth.  In spina bifida, “the backbone and spinal canal do not close before birth”[1] as they normally would.

PubMed Health, a service of the United States National Library of Medicine, states “Normally, during the first month of a pregnancy, the two sides of the spine (or backbone) join together to cover the spinal cord, spinal nerves and meninges (the tissues covering the spinal cord).”[2]  In spina bifida, this does not happen, causing “the spinal cord and meninges (the tissues covering the spinal cord) to stick out of the child’s back.”[3]

Prozac Lawyer Celexa Lawyer SSRI Birth Defect Lawsuit SSRI Attorney - Spina Bifida

In the general population, spina bifida “may affect as many as 1 out of every 800 infants,”[4] but several risk factors that increase the chances of a baby being born with spina bifida have recently been established.  First, low levels of the vitamin folic acid in pregnant mothers are currently believed to place newborns at risk because of folic acid’s known role in the development of the brain and spinal cord.[5]  It is also believed that a virus may play a role in the incidence of spina bifida in newborns “since there is a higher rate of this condition in children born in the early winter months.”[6]  It has also recently been discovered that maternal use of selective serotonin reuptake inhibitor (SSRI) antidepressant drugs during pregnancy can dramatically raise the risk of spina bifida in newborns.  The main SSRI linked to spina bifida is Celexa®, but use of other SSRI drugs such as Zoloft®, Paxil®, Prozac®, and Lexapro® may also place children at increased risk.

 

Signs of Spina Bifida

Signs that your child may be born with spina bifida are numerous.  Symptoms include “loss of bladder or bowel control,”[7] “partial or complete lack of sensation,”[8] “partial or complete paralysis of the legs,”[9] “weakness of the hips, legs, or feet of a newborn,”[10] “abnormal feet or legs, such as clubfoot,”[11] “build up of fluid inside the skull (hydrocephalus),”[12] “hair at the back part of the pelvis called the sacral area,”[13] and “dimpling of the sacral area.”[14]

Much of the time, a neurologist can test for spina bifida before birth with a blood test known as a “quadruple screen,”[15] which evaluates the newborn’s level of the protein “maternal alpha fetoprotein,”[16] as higher levels of maternal alpha fetoprotein are indicative of (but do not confirm) a spina bifida diagnosis.[17]  Confirmation of a spina bifida diagnosis before birth requires either pregnancy ultrasound or aminocentesis.[18]

After birth, a physician may see that a child has spina bifida though a neurologic examination, which “may show that the child has loss of nerve-related functions below the defect. For example, watching how the infant responds to pinpricks at various locations may reveal where he or she can feel the sensations.  Tests done on the baby after birth may include x-rays, ultrasound, CT, or MRI of the spinal area.”[19]

 

Complications of Spina Bifida

Though this list may not be all-inclusive, PubMed Health states that complications of spina bifida can include:

  • “Difficult delivery with problems resulting from a traumatic birth, including cerebral palsy and decreased oxygen to the brain
  • Frequent urinary tract infections
  • Hydrocephalus
  • Loss of bowel or bladder control
  • Meningitis
  • Permanent weakness or paralysis of legs”[20]

Research Links Spina Bifida to Maternal Use of SSRI Antidepressants

A study from Finland published in a 2011 edition of Obstetrics and Gynecology has found a strong link between maternal use of SSRIs during pregnancy and spina bifida.  This study, published by Heli Malm, MD, Ph.D. et al. has found that infants born to mothers who used Celexa® during pregnancy were about 2.4 times more likely to be born with neural tube defects such as spina bifida than were children born to mothers who did not use SSRIs during pregnancy.[21]

Treatment for Spina Bifida

Usually, surgery early on in a child’s life is required to correct spina bifida because it is dangerous for the child to have its spinal cord partially exposed, unprotected by the spine.  Sadly, “most children will require lifelong treatment for problems that result from damage to the spinal cord and spinal nerves. This includes:

  • Gentle downward pressure over the bladder may help drain the bladder. In severe cases, drainage tubes, called catheters, may be needed. Bowel training programs and a high fiber diet may improve bowel function.
  • Orthopedic or physical therapy may be needed to treat musculoskeletal symptoms. Braces may be needed for muscle and joint problems.
  • Neurological losses are treated according to the type and severity of function loss.
  • Follow-up examinations generally continue throughout the child’s life. These are done to check the child’s developmental level and to treat any intellectual, neurological, or physical problems.
  • Visiting nurses, social services, support groups, and local agencies can provide emotional support and assist with the care of a child with a myelomeningocele who has significant problems or limitations.”[22]

We are here to help you

Due to the fact that the manufacturers of Celexa® and other dangerous SSRI drugs do not include anything about birth defects such as spina bifida on their warning labels in the face of clear evidence of their capacity to increase the risk for newborns being born with major birth defects, a number of Celexa® lawsuits and other SSRI birth defect lawsuits are currently being filed.  If you used an SSRI during pregnancy, unaware of the risks posed to your developing child, and your child was born with spina bifida or another birth defect, please do not hesitate to contact our law firm at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us for a free, no-obligation case consultation.

We have the experience, resources, and skills required to go up against even the largest of pharmaceutical companies and win the justice you and your family deserve.

[1] “Myelomeningocele – PubMed Health” PubMed Health. U.S. National Library of Medicine. © 2012 A.D.A.M., Inc. Available at <http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002525/> Accessed 4 February 2013

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.

[6] Ibid.

[7] Ibid.

[8] Ibid.

[9] Ibid.

[10] Ibid.

[11] Ibid.

[12] Ibid.

[13] Ibid.

[14] Ibid.

[15] Ibid.

[16] Ibid.

[17] Ibid.

[18] Ibid.

[19] Ibid.

[20] Ibid.

[21] Malm, H., et al. (2011) “Selective Serotonin Reuptake Inhibitors and Risk for Major Congenital Anomalies” Obstetrics and Gynecology Vol. 118, Issue 1; pp. 111-120.

[22] “Myelomeningocele – PubMed Health” PubMed Health. U.S. National Library of Medicine. © 2012 A.D.A.M., Inc. Available at <http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002525/> Accessed 4 February 2013

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.

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.

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.

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.

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.

I recently came across a 2000 article from University of North Carolina, Chapel Hill by J.R. Moiseiwitsch et al., titled “The role of serotonin and neurotransmitters during craniofacial development.”.  This article, published in Critical Reviews in Oral Biology and Medicine, demonstrates how prenatal exposure to SSRI drugs affects craniofacial development, all too often resulting in birth defects such as cleft lip and cleft palate.

The team writes, “Several neurotransmitters, in particular serotonin (5-HT), have demonstrated multiple functions during early development and mid-gestational craniofacial morphogenesis. Early studies indicated that 5-HT is present in the oocyte, where it appears to function as a regulator of cell cleavage. Later, it has a significant role during gastrulation, during which there are significant areas of 5-HT uptake in the primitive streak. Subsequently, in association with neurulation, 5-HT uptake is seen in the floor plate of the developing neural tube.”

This may help show how gestational exposure to SSRIs can lead to neural tube defects, such as spina bifida.

Continuing, it is stated that “During neural crest formation and branchial arch formation, 5-HT has been demonstrated to facilitate cell migration and stimulate cell differentiation. During morphogenesis of the craniofacial structures, 5-HT stimulates dental development and may aid in cusp formation. All of the most commonly prescribed antidepressant drugs inhibit serotonin uptake, yet they do not appear to cause major craniofacial malformations in vivo. Given the wide spectrum of effects that 5-HT has during development, it is difficult to understand why these anti-depressants are not major teratogens. Redundancy within the system may allow receptor and uptake pathways to function normally even with lower than normal levels of circulating serotonin. Serotonin-binding proteins, that are expressed in most craniofacial regions at critical times during craniofacial development, may have a buffering capacity that maintains adequate 5-HT tissue concentrations over a wide range of 5-HT serum concentrations.”

Stating that “Dental development appears to be particularly sensitive to even small fluctuations in concentrations of 5-HT. Therefore, it may be that children of patients who have received selective serotonergic re-uptake inhibitors (such as Prozac and Zoloft) or the less selective tricyclic anti-depressant drugs (such as Elavil) would be at a higher risk for developmental dental defects such as anodontia and hypodontia”, we can see how SSRIs are linked to craniofacial birth defects.

Since so many women have used SSRIs unaware of the risk for birth defects, SSRI birth defect lawsuits are currently being filed around the world.  If you or a loved one used SSRIs such as Prozac or Zoloft 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.

Today, I found an article titled “Major congenital malformations following prenatal exposure to serotonin reuptake inhibitors and benzodiazepines using population-based health data.” that originally appeared in the February, 2008 edition of Birth Defects Research.  This insightful piece of research by TF Oberlander and a team of researchers from The University of British Columbia (Vancouver) provides more important insight into the link between exposure to selective serotonin reuptake inhibitor drugs (SSRIs) and adverse birth outcomes such as defects like spina bifida, ventricular septal defect, cleft lip and cleft palate, and developmental disorders such as autism.

Evaluating “Population health data, maternal health, and prenatal prescription records” and comparing them to “neonatal records, representing all live births (British Columbia, Canada, N=119,547) during a 39-month period (1998-2001),” researchers studied the rate of major congenital anomalies (CA) and congenital heart disease (CHD).

Researchers found that “The risk for an ASD was higher following SRI monotherapy compared with no exposure, after adjustment for maternal covariates.”  For clarity, “ASD” here stands for atrial septal defect, a heart defect.

Because so many women have used SSRIs during pregnancy unaware of the risk for heart defects and other adverse birth outcomes, a number of SSRI birth defect lawsuits have been filed.

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

(855) 452 – 5529

justinian@dangerousdrugs.us

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