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Dangerous Drugs & Medical Devices

News & Commentary on Prescription Drug & Medical Device Lawsuits

2014 – Benicar linked to severe gastrointestinal disease

Posted in Benicar

In May 2014, Hélène Théophile and a team of researchers published an article titled “Five cases of sprue-like enteropathy in patients treated by olmesartan,” which further demonstrated that exposure to Benicar (olmesartan) is linked to an increased risk for severe gastrointestinal disease.

Here is the abstract for that article:

“We describe five cases of sprue-like enteropathy during treatment with olmesartan, [a drug] indicated for the treatment of hypertension. Patients presented severe diarrhoea, significant weight loss or dehydration, with or without intestinal villous atrophy. Clinical signs ceased upon drug discontinuation in all cases; olmesartan was reintroduced in two cases and rechallenge was positive in both. These add to the previously reported cases that led to a label change for olmesartan in the United States. However, all cases were observed in a small gastroenterology unit, which suggests that this adverse effect may not be rare. A preliminary search for the other angiotensin II receptor antagonists in the French pharmacovigilance system found severe diarrhoea and colitis, but no case with villous atrophy. Therefore, in the presence of severe diarrhoea, olmesartan or other angiotensin II receptor antagonists should be discontinued, even if the treatment has been taken for several months or years.” (emphasis added)

Due to the fact that the manufacturer of Benicar has failed time and again to adequately inform users of these and other serious risks, a number of Benicar lawsuits are currently being filed.  If you or a loved one used Benicar and suffered gastrointestinal disease, you too may be entitled to significant financial compensation.

For a free, no-obligation case consultation, contact our team of Benicar lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

Call today and see how we can help.

Benicar linked to severe gastrointestinal disease

Posted in Benicar

In January, 2013, an article by Stephanie E. Dreifuss and a team from University of Pittsburgh published an article in Case Reports in Gastrointestonal Medicine titled “Spruelike enteropathy associated with olmesartan: an unusual case of severe diarrhea.”.  There, the connection between the high blood pressure drug Benicar (olmesartan) and sprue like enteropathy was again made clear.

In their paper, the team describes the case of a “64-year-old male with a history of hypertension [who] presented with worsening diarrhea and 25-pound weight loss over the preceding three months.” (emphasis added)

Dreifuss et al. continue: “Prior screening colonoscopy was unremarkable, and the patient failed conservative management. On presentation, the patient had orthostatic hypotension associated with prerenal azotemia for which olmesartan(40mg/day) was held.”

At first, the “Initial workup for chronic diarrhea was essentially unremarkable. Then, EGD was performed with small bowel biopsy, which showed a moderate villous blunting and an intraepithelial lymphocyte infiltration.”

Thankfully, after two months, the man “achieved a complete resolution of diarrhea and regained 20-pound weight.”

However, the team concluded that “Spruelike enteropathy is a clinical entity manifested by chronic diarrhea and intestinal villous atrophy. Spruelike enteropathy associated with olmesartan as a cause of drug-induced diarrhea is rare, and it has been reported only in a case series to date. This case highlighted the importance for clinicians to maintain a high index of suspicion for olmesartan as a precipitant of spruelike enteropathy.” (emphasis added)

Due to the fact that the manufacturers of Benicar (olmesartan) have failed time and again to adequately warn users of this risk, the FDA required the warning labels be updated in 2013 and a great number of Benicar lawsuits have been filed.

If you or a loved one used Benicar and suffered sprue-like enteropathy, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Benicar 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

2014 – Birth defects risk increased 250% with Depacon / Depakene / Depakote

Posted in Depacon / Depakene / Depakote

In recent years, dozens of studies have been published illustrating an increased risk for birth defects linked to antiepileptic drugs containing sodium valproate such as Depacon, Depakene, and Depakote.  While these drugs are effective in the mitigation of seizures, the risks posed to developing babies cannot go overlooked.  Here, I will summarize one such study by G. Veiby et al., first appearing in the March, 2014 edition of Journal of Neurology.  This study was titled “Fetal growth restriction and birth defects with newer and older antiepileptic drugs during pregnancy.” and comes from University of Bergen (Bergen, Norway).

The team writes, “Deliveries recorded in the compulsory Medical Birth Registry of Norway 1999-2011 formed the study population.”  In all, “2,600 children exposed to antiepileptic drugs during pregnancy were compared to all 771,412 unexposed children born to women without epilepsy.”

Among other things, results showed that “Valproate monotherapy was associated with a significant risk of birth defects (6.3 vs. 2.9 %; OR 2.5; CI 1.6-3.8), and specifically with septal heart defects and hypospadias.”  This means that children exposed to valproate in utero were 2.5 times as likely to be born with birth defects, specifically heart defects.

The team also found that if a mother who used valproate in pregnancy bore a child with a birth defect, the likelihood that she would bear another with a defect was 10.4 times higher than if she had not used the drug.

Because the manufacturers of these drugs have failed time and again to warn women of these risks, 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.

SSRIs linked to “abnormal development” of fetus

Posted in SSRI Birth Defects

In 2012, C.M. Nijenhuis and a team from University of Groningen (Groningen, The Netherlands) published a study titled “Disturbed development of the enteric nervous system after in utero exposure of selective serotonin re-uptake inhibitors and tricyclic antidepressants. Part 1: Literature review.” in British Journal of Clinical Pharmacology.  There, the link between gestational exposure to selective serotonin reuptake inhibitor drugs (SSRIs) and poor birth outcomes was further explored.

The team states “The increase in selective serotonin re-uptake inhibitor (SSRI) use during pregnancy, questions concerning abnormal development of the enteric nervous system (ENS), increase in laxative use in children and the association of fluoxetine with infantile hypertrophic pyloric stenosis (IHPS) gave rise to this pharmacological literature review.”

“The literature study showed that SSRIs may influence the development of the ENS in two ways. Blockage of the serotonin re-uptake transporter (SERT) during foetal development could influence migration, differentiation and survival of cells. This could lead to abnormal development in the first trimester of pregnancy.” (emphasis added)

For clarity, “5-HT” is scientific shorthand for serotonin.  The team continues, “5-HT seems to be a growth factor in the primitive ENS. This growth factor like action is mediated through the 5-HT(2B) receptor and stimulation of this receptor by SSRIs influences the fate of late-developing enteric neurons. This could lead to abnormal development in the second and third trimester.” (emphasis added)

Due to the fact that the manufacturers of many SSRI drugs have failed time and again to provide adequate warning to women using their drugs during pregnancy, SSRI birth defect lawsuits have been filed by the thousands around the world.

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

2009 – Preterm birth again linked to SSRI exposure before birth

Posted in SSRI Birth Defects

Recently, I found an article titled “Risk of preterm delivery and other adverse perinatal outcomes in relation to maternal use of psychotropic medications during pregnancy.” that originally appeared in the December 2009 edition of American Journal of Obstetrics and Gynecology.  Published by R. Calderon-Margalit and a team from The University of Washington School of Public Health and Community Medicine (Seattle, WA), this article further explored the link between exposure to selective serotonin reuptake inhibitor drugs (SSRIs) and poor birth outcomes.

The team’s stated objective was “to determine the association of maternal psychotropic medication use during pregnancy with preterm delivery and other adverse perinatal outcomes.”

For this study, “A cohort of 2793 pregnant women in Washington State was interviewed, and their medical files were abstracted.  After statistical analyses were performed, results showed that “Maternal use of benzodiazepine during pregnancy was associated with an increased risk of preterm delivery (adjusted odds ratio, 6.79; 95% confidence interval, 4.01-11.5) and with increased risks of low birthweight, low Apgar score, neonatal intensive care unit admissions, and respiratory distress syndrome. Selective serotonin receptor inhibitors were associated with preterm deliveries only among women who started treatment after the first trimester.”

Since most women use SSRIs in pregnancy unaware of the risk for preterm delivery due to the manufacturer’s failure to warn, thousands of SSRI birth defect lawsuits are currently being filed around the world.

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

Risk for birth defects 47% higher with prenatal exposure to Depacon, Depakene, or Depakote

Posted in Depacon / Depakene / Depakote

In January of last year, a team of researchers led by E. Campbell published an article in Epilepsia titled “Recurrence risk of congenital malformations in infants exposed to antiepileptic drugs in utero.”, marking yet another piece of professional research illustrating the risks of prenatal exposure to drugs containing sodium valproate such as Depacon, Depakene, and Depakote.

This team from Belfast (United Kingdom) states plainly at the outset of their abstract that “Use of antiepileptic drugs in pregnancy is associated with congenital malformations and developmental delay. Previous studies have suggested that women who have had one child with a congenital malformation are at increased risk of having other children with malformations”, and as such “sought to confirm the magnitude of risk in a large cohort drawn from the United Kingdom Epilepsy and Pregnancy Register.”

Campbell explains that “Outcome data were available for 1,534 pregnancies born to 719 mothers. For women whose first child had a congenital malformation there was a 16.8% risk of having another child with a congenital malformation, compared with 9.8% for women whose first child did not have a malformation (relative risk 1.73, 95% confidence interval [CI] 1.01-2.96).”

If women had two children with birth defects, the risk for bearing a third was 50%.

“There was a trend toward a higher risk for recurrent malformations in pregnancies exposed to valproate (21.9%, relative risk 1.47, 95% CI 0.68-3.20) and topiramate (50%, relative risk 4.50, 95% CI 0.97-20.82), but not for other drugs such as carbamazepine and lamotrigine.”  This means that if a baby was exposed to Depacon, Depakene, or Depakote at normal maternal doses in pregnancy, the risk for birth defects was 47% than for neonates who faced no such exposure.

Due to the fact that Abbott Laboratories, the manufacturer of Depacon, Depakote, and Depakene, has failed time and again to adequately warn women of the increased risk for birth defects associated with these drugs, thousands of Depacon birth defect lawsuits are currently being filed.

If you or a loved one used Depacon, Depakote, or Depakene while pregnant and gave birth to a child with a birth defect or developmental disorder, 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.

Study shows: Depacon lifts risk for autism 300%

Posted in Depacon / Depakene / Depakote

Today, I found another article by G. Veiby and a team from The University of Bergen in Bergen, Norway that demonstrates the danger posed to children exposed to valproate in utero.  Valproate (sodium valproate, other formations) is the active chemical in a number of antiepileptic drugs such as Depacon, Depakote, and Depakene.  The article I will summarize here appeared in the August, 2013 edition of Epilepsia and was titled “Exposure to antiepileptic drugs in utero and child development: a prospective population-based study.”.

Veiby et al. (2013) write “Antiepileptic drugs may cause congenital malformations. Less is known about the effect on development in infancy and childhood. The aim of this study was to examine whether exposure to antiepileptic drugs during pregnancy has an effect on early child development.”

Using the Medical Birth Registry (Norway) the team studied children born between 1999 and 2008 numbering 108,264 in all, of which 333 “were exposed to antiepileptic drugs in utero.”

The team states “At 18 months, the exposed children had increased risk of abnormal scores for gross motor skills (7.1% vs. 2.9%; OR 2.0, 95% confidence interval [CI] 1.1-3.7) and autistic traits (3.5% vs. 0.9%; OR 2.7, CI 1.1-6.7) compared to children of parents without epilepsy.”  (Children born to mothers who used Depacon or another valproate drug were twice as likely to have abnormal scores for gross motor skills and 2.9 times as likely to be born with symptoms of autism 18 months.)

Veiby et al. (2013) continue: “At 36 months, the exposed children had increased risk of abnormal score for gross motor skills (7.5% vs. 3.3%; OR 2.2, CI 1.1-4.2), sentence skills (11.2% vs. 4.8%; OR 2.1, CI 1.2-3.6), and autistic traits (6.0% vs. 1.5%; OR 3.4, CI 1.6-7.0).”  (Children exposed to Depakote were 3.4 times as likely to be born with traits of autism at 36 months of life.)

Further, “The drug-exposed children also had increased risk of congenital malformations (6.1% vs. 2.9%; OR 2.1, CI 1.4-3.4”.  This means that children born to mothers who used drugs like Depacon and Depakote were more than twice as likely as non-exposed children to be born with birth defects.

Accordingly, the team concluded that “Exposure to antiepileptic drugs during pregnancy is associated with adverse development at 18 and 36 months of age, measured as low scores within key developmental domains rated by mothers.”

Since so many mothers have used Depacon and other drugs containing valproate in pregnancy unaware of the increased risk for birth defects and developmental disorders like autism, thousands of Depacon birth defect lawsuits have been filed in recent years.

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

2011 – Birth defect risk “significantly higher” with Depacon, Depakene, or Depakote exposure before birth

Posted in Depacon / Depakene / Depakote

In July, 2011, Lancet Neurology published an article titled “Dose-dependent risk of malformations with antiepileptic drugs: an analysis of data from the EURAP epilepsy and pregnancy registry.” that was written by a team from Stockholm led by T. Tomson.  This study is yet another example of peer-reviewed research demonstrating that serious risks are posed to children whose mothers used antiepileptic drugs containing valproate (Depakote, Depakene, Depacon, etc.) during pregnancy.

Tomson et al. open by writing simply “Prenatal exposure to antiepileptic drugs is associated with a greater risk of major congenital malformations, but there is inadequate information on the comparative teratogenicity of individual antiepileptic drugs and the association with dose.”  As such, the team “aimed to establish the risks of major congenital malformations after monotherapy exposure to four major antiepileptic drugs at different doses.”  That is, the team wanted to find the risk for birth defects linked to drugs individually.

Using data from the EURAP epilepsy and pregnancy registry (“an observational cohort study representing a collaboration of physicians from 42 countries”), Tomson “assessed rates of major congenital malformations in 1402 pregnancies exposed to carbamazepine, 1280 on lamotrigine, 1010 on valproic acid, and 217 on phenobarbital.”  (Valproic acid is another form of valproate, identical in biochemical effect.)

The team found “An increase in malformation rates with increasing dose at the time of conception was recorded for all drugs. Multivariable analysis including ten covariates in addition to treatment with antiepileptic drugs showed that the risk of malformations was greater with a parental history of major congenital malformations (odds ratio 4·4, 95% CI 2·06-9·23).”

“Compared with lamotrigine monotherapy at doses less than 300 mg per day, risks of malformation were significantly higher with valproic acid and phenobarbital at all investigated doses, and with carbamazepine at doses greater than 400 mg per day.”

Because thousands of women around the world have used Depacon, Depakene, and Depakote while pregnant unaware of the increased risk for birth defects associated therein, Depacon birth defect lawsuits have been 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, 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, compassion, 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.

SSRIs in pregnancy linked to 12-fold increased risk for preterm birth

Posted in SSRI Birth Defects

Today, I came across an article published in a 2011 edition of Journal of Midwifery and Women’s Health by G. Latendresse and a team of researchers from The University of Utah College of Nursing (Salt Lake City) titled “Maternal corticotropin-releasing hormone and the use of selective serotonin reuptake inhibitors independently predict the occurrence of preterm birth.”.  There, the connection between prenatal exposure to selective serotonin reuptake inhibitor drugs (SSRIs) and poor birth outcomes was further explored.  To-date, many articles have found that neurological birth defects, heart defects, and adverse birth outcomes such as preterm birth have been linked to gestational exposure to SSRIs.

Latendresse et al. (2011) write that “Although the purpose of this small, preliminary study was to evaluate the association between chronic maternal stress and PTB, this report focuses on the unexpected finding of the association between maternal use of selective serotonin reuptake inhibitors (SSRIs) and PTB.”  (“PTB” stands for preterm birth.)  In all, 100 pregnant women were studied.

The team found that “Pregnant women who used SSRIs to treat depression and/or anxiety were nearly 12 times more likely to give birth before term when compared with women who did not use these medications.” (emphasis added)

Due to the fact that the manufacturers of many SSRI drugs have failed time and again to warn women of these and other serious risks related to SSRI exposure, SSRI birth defect lawsuits are currently being filed around the world.

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

2011 – Low gestational age linked to SSRI exposure, not maternal depression

Posted in SSRI Birth Defects

Titled “Newborn neurobehavioral patterns are differentially related to prenatal maternal major depressive disorder and serotonin reuptake inhibitor treatment.”, an article by A.L. Salisbury and a team from the Warren Alpert Medical School of Brown University, appearing in the December, 2011 edition of Depression and Anxiety, further explores the link between selective serotonin reuptake inhibitor drugs (SSRIs) and adverse neurobehavioral outcomes.  To-date, a number of studies have linked SSRI exposure to increased risk for heart defects and neurological birth defects as well.

Salisbury et al. (2011) write “Prenatal serotonin reuptake inhibitor (SRI) exposure has been related to adverse newborn neurobehavioral outcomes; however, these effects have not been compared to those that may arise from prenatal exposure to maternal major depressive disorder (MDD) without SRI treatment. This study examined potential effects of MDD with and without SRI treatment on newborn neurobehavior.”  For clarity, “SRI” is equivalent to “SSR” for our purposes.

“This was a prospective, naturalistic study”, and results showed that “Full-term infants exposed to MDD + SRIs had a lower [gestational age] than [control subjects] or MDD-exposed infants and, controlling for GA, had lower quality of movement and more central nervous system stress signs. In contrast, MDD-exposed infants had the highest quality of movement scores while having lower attention scores than CON and MDD + SRI-exposed infants.”

This means that maternal SSRI use, not maternal depression, was correlated with lower gestational age.

Since so many women around the world have used SSRIs during pregnancy unaware of these and other serious risks, thousands of SSRI birth defect lawsuits are currently being filed.

If you or a loved one used SSRIs while pregnancy and gave birth to a child with a birth defect or who suffered perinatal complications, 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 researchers 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.