May 2014

An article by Laura Pogliani et al. (2010) titled “Paroxetine and neonatal withdrawal syndrome” published in BMJ Case Reports reports on a newborn who suffered neonatal withdrawal syndrome after prenatal exposure to paroxetine (Paxil).

Here is the abstract of that article:

“We report a case of neonatal withdrawal syndrome after in utero exposure to paroxetine 20 mg/day. The infant’s symptoms, such as poor neonatal adaptation, respiratory distress, decerebrate posturing, irritability and tremors, commenced soon after birth and persisted for 5 days. All neonates exposed to antidepressants, particularly serotonin reuptake inhibitors (SSRIs), during the last trimester should be followed-up closely for adverse symptoms.”

Like many of her contemporaries, Pogliani cites that “there is accumulating evidence that maternal SSRIs treatment during pregnancy may cause adverse pregnancy outcomes, such as a higher rate of spontaneous abortions, lower birth weight and shorter gestation, or an increased proportion of children with minor anomalies.”

This child was born after 38 weeks gestation at six pounds, twelve ounces to a 32-year-old mother who used Paxil for the last six months of pregnancy.  Shortly after birth, the child showed poor adaptation and “respiratory distress,” and “ became tachypnoeic, he put on decerebrate posturing, showed increased tonus and reflexes, irritability and tremors.”  Thankfully, as is the case with most incidents of neonatal adaptation syndrome, symptoms subsided after about a week, and the child recovered.

The team writes “Even if it is difficult to assess the specific SSRIs that are more likely to cause NAS symptoms, infants exposed to paroxetine show the more severe neonatal withdrawal syndrome” and concludes that “infants exposed to SSRIs should be closely monitored after birth for a minimum of 48 h and, particularly those who develop severe symptoms, should be followed to assess the long term effects of prolonged exposure to SSRIs.

The high prevalence of NAS in infants exposed to SSRIs in utero should be brought to the attention of family doctors, psychiatrists, gynaecologists, paediatricians, and the possibility of such symptoms needs to be discussed with women.”

Because many women have used Paxil unaware of the risk for neonatal adaptation syndrome (NAS), a number of Paxil® birth defect lawsuits have been filed.  If you or a loved one used Paxil and gave birth to a child with a congenital malformation, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Prozac® birth defects 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.

In 2010, a team of Italian researchers led by Maria Marsella, from The University of Ferrara, published a case report in The Italian Journal of Pediatrics titled “Prenatal exposure to serotonin reuptake inhibitors: a case report”, shedding more light onto the link between selective serotonin reuptake inhibitors (SSRIs) and birth defects.

The team writes “Two premature twins (33 weeks gestation) were born to a woman who had used paroxetine during pregnancy for an anxiety-depression disorder. They were admitted to the NICU, where they showed prolonged RDS, cardiovascular malformations, and facial dysmorphisms. Soon after birth, they also presented abnormal neurobehavioral and motor signs, which partially disappeared during the following weeks, although alterations of tone persisted even at discharge.”  (NICU stands for neonatal intensive care unit, and RDS stands for respiratory distress syndrome, symptomatic of persistent pulmonary hypertension of the newborn, an ailment frequently linked to children exposed to SSRI drugs before birth.)

Marsella et al. (2010) continues, “Selective serotonin reuptake inhibitor (SSRI) antidepressants are considered the primary treatments for depression and anxiety in pregnancy. Since intrauterine exposure to these drugs has been associated with poor neonatal adaptation, low birth weight, RDS, neurobehavioural symptoms, and potential teratogenic effects, further studies are needed to assess risks and mechanism of action of SSRIs” and cautions that “Meanwhile, it is advisable to evaluate for each patient the real risk/benefit ratio of continuing or suspending treatment during pregnancy.”

“In utero exposure to an SSRI has been associated with many neonatal symptoms, including respiratory distress, feeding difficulties, and a wide spectrum of neurological symptoms. A neonatal abstinence syndrome (NAS), resulting from exposure to SSRIs during pregnancy, may explain this clinical syndrome, characterized by central nervous system, gastrointestinal, autonomic and respiratory symptoms [2,3]. In a cohort study, symptoms of NAS were present in 30% of exposed infants compared to none of the non-exposed control infants [4].

Furthermore, concerns regarding persistent pulmonary hypertension, teratogenic risks, and neonatal adaptation have also been raised. In particular, recent studies have indicated an increased prevalence of certain malformations, as omphalocele, craniosynostosis, and, more consistently, heart defects in newborns exposed to SSRIs in utero [48].”

Eventually, and with a great deal of medical intervention, the twins recovered.  Unfortunately, that is not often the case.  Due to the fact that the manufacturers of many SSRI drugs have failed time and again to adequately inform women of these risks, a number of expecting mothers have unknowingly presented serious risks to developing babies, and many 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 developmental or adaptation difficulty, 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.

In recent years, a number of studies have demonstrated that Depacon (sodium valproate) use during pregnancy is linked to increased risk for a range of serious birth defects.  This epilepsy drug by Abbott Laboratories, Inc. is often safe, but has been linked to autism, neurological birth defects, heart defects, craniofacial birth defects, and a number of other adverse fetal outcomes.

In 2011, a study by S. Gentile was published in Current Opinion in Psychiatry, titled “Drug treatment for mood disorders in pregnancy.” citing this connection further.

Among the drugs evaluated, Gentile found “valproate is the medication which shows the strongest association with fetal anomalies”, ie birth defects.  And, “An increased risk of autism-spectrum disorders and infant neurodevelopmental delay is also associated with valproate exposure through the placenta.”

Linking this drug with others that can cause birth defects, such as SSRIs and birth defects, the author concludes, “Avoiding the use of clorimipramine, paroxetine, valproate, and atypical antipsychotics during pregnancy is advisable. However, when starting or continuing pharmacological treatment during pregnancy, clinicians should consider not only the intrinsic iatrogenic risk of birth defects or perinatal complications, but also the general safety profile for the expectant mother.”  (“Paroxetine” is the chemical name for Paxil.)

Due to the fact that SSRI manufacturers and the manufacturer of Depacon have failed time and again to adequately warn users of the risk for birth defects, a number of SSRI birth defect lawsuits and Depacon birth defect lawsuits have been filed.  If you or a loved one used Depacon or Paxil during pregnancy and had a child with a congenital malformation , you may be entitled to significant financial compensation.  For a free, no-obligation case consultation contact our team of Paxil® birth defect lawyers and 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 – 5529

justinian@dangerousdrugs.us

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

A French team of researchers led by S. Favrelière et al. published an article in L’Encephale titled “Treatment of depressed pregnant women by selective serotonin reuptake inhibitors: risk for the foetus and the newborn” in June, 2010 and provided further insights into the risks associated with selective serotonin reuptake inhibitor (SSRI) use during pregnancy posed to unborn children.

Reviewing literature, the team found that “The prevalence of depression during pregnancy is of around 10 to 20% of the population of childbearing women” and states that “Depression is often misdiagnosed and underestimated in pregnant women. Starting a pharmacological treatment for depression in these women is not easy because data concerning the safety of antidepressants during pregnancy are still unclear.”

In addition to problems for expecting mothers, “Foetal development is also affected and adverse outcomes such as prematurity, low birth weight, irritability, and sleep disorders are frequent.”  However, non-pharmaceutical treatment for maternal depression may be insufficient, thus women and doctors must weigh risks and make decisions on a case-by-case basis.

“In general, drugs have a low teratogenic potential, only 4 to 5% of malformations are iatrogenic. Teratogenic risk is high between conception until the end of the second month of gestation. Safety of SSRIs treatment during pregnancy and potential risk for the foetus and newborn were unquestioned before publication, in the late 2005, of some alarming data concerning a possible teratogenic effect. Studies showed an increased risk for all congenital malformations with SSRIs and particularly with paroxetin. A few studies after 2005 have also found an association between prenatal exposure to SSRIs (especially paroxetin) and congenital malformations.”

For clarity, “paroxetin” (or “paroxetine”) is the chemical name for Paxil, an SSRI manufactured by GlaxoSmithKline (GSK).  The authors continue: “Numerous studies in pregnant women have shown that SSRI treatments are associated with a significant increase of spontaneous abortion, preterm birth, and low birth weight. Exposure to SSRIs in late pregnancy has been associated with a three-fold increased risk of neonatal behavioural syndrome, including signs of withdrawal or serotonin impregnation. Restlessness, poor tone, respiratory distress, hypoglycaemia were the most frequent signs. … Recent studies have also documented an increased risk of persistent pulmonary hypertension and cases of cerebral haemorrhage have been described.”

Concluding “Although a number of studies revealed that SSRIs are not teratogenic, some of them showed congenital malformations associated with use of these antidepressants; in particular an increased risk of cardiac defects with paroxetin”, studies like this can be used as evidence in a Paxil® birth defects lawsuits to demonstrate the GSK knew, or should have known, the risks associated with the use of this drug during pregnancy.

If you or a loved one used Paxil and gave birth to a child with a congenital malformation, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Paxil® birth defects 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.

Over the past several decades, a number of studies have linked selective serotonin reuptake inhibitors (SSRIs) to a range of birth defects: neurological birth defects including spina bifida, cardiovascular birth defects including tricuspid atresia, craniofacial defects like cleft palate, developmental disorders such as autism, and neonatal adaptation disorders.  As the manufacturers of many SSRIs have failed to notify expecting mothers of these risks, a number of SSRI birth defect lawsuits have been filed.

Here, I present another mention of this connection, published in a 2010 edition of Reproductive Toxicology by M. Effolk and H. Malm of Helsinki University Central Hospital (Finland).  Their article is titled “Risks associated with in utero and lactation exposure to selective serotonin reuptake inhibitors (SSRIs).

The team states “Prenatal exposure to selective serotonin reuptake inhibitors (SSRIs) may increase risk for congenital malformations and adverse perinatal outcome” and performed a literature review.

Results showed that “paroxetine and possibly fluoxetine use in early pregnancy may be associated with a small increased risk for cardiovascular malformations. Perinatal adverse effects, including respiratory distress and neonatal adaptation problems are common in exposed infants, and an increased risk for persistent pulmonary hypertension of the newborn (PPHN) has been observed.”  These findings are largely in line with other similar research.  To see more studies linking SSRIs and birth defects, follow the preceding link.

If you or a loved one used SSRIs and had a child who was born with a congenital malformation, developmental disorder, or who had a poor neonatal adaptation, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of SSRI birth defects 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.

Published on April 15th, 2012, an important letter to the editor of American Family Physician was sent by Dr. Brian Budenholzer that cautioned against Paxil use during pregnancy.  (Accordingly, his piece was titled “Paroxetine Use Should Be Avoided During Pregnancy”.)  As it is relatively short, I have chosen to include it in its entirety below.

“To The Editor: In the FPIN’s Clinical Inquiries on which antidepressants are safe to use during pregnancy, Dr. Patel and colleagues suggest that paroxetine (Paxil) is safe. Although they note that the American College of Obstetricians and Gynecologists recommends avoiding paroxetine use during pregnancy, they do not provide the evidence supporting the recommendation. Paroxetine actually carries a category D rating from the U.S. Food and Drug Administration (FDA) for safety in pregnancy.

Two studies have found an association between first trimester paroxetine use and congenital malformations, notably cardiac malformations. The first study, completed in 2005, showed “a trend towards a 1.5-fold increased risk for cardiovascular malformations for paroxetine compared to other antidepressants. This study also showed a statistically significant increased overall risk of major congenital malformations (inclusive of the cardiovascular defects) in infants exposed to paroxetine compared to other antidepressants.”1

In the second study, an analysis of data from the Swedish Medical Birth Register revealed an association between use of paroxetine and cardiovascular congenital defects, most notably ventricular and atrial septal defects.2 On the basis of these two studies and at the FDA’s request, GlaxoSmithKline downgraded their rating of paroxetine safety in pregnancy to category D.3

When this information is added to the data presented by the authors, I believe the evidence supports avoiding paroxetine use during pregnancy, especially in the first trimester. Physicians should also consider this evidence when counseling women of childbearing age about medication choices for depression.

BRIAN BUDENHOLZER, MD

Greenville, N.C.”

Due to the fact that the manufacturers of Paxil have time and again failed to warn users of the risk for congenital anomalies, a number of Paxil® birth defect lawsuits have been filed.

If you or a loved one used Paxil and gave birth to a child with a congenital malformation, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Paxil® 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.

Published in the September, 2011 edition of Danish Medical Bulletin, an article by J. Fenger-Grøn et al. titled “Paediatric outcomes following intrauterine exposure to serotonin reuptake inhibitors: a systematic review.” “addresses the potential adverse effects on the foetus and child of maternal SRI medication.”  For clarity, “SRI” stands for serotonine reuptake inhibitors, and for our purposes is equivalent to “selective serotonin reuptake inhibitors,” or SSRIs.

This research team states “The literature indicates a slightly increased risk of cardiovascular malformations and persistent pulmonary hypertension of the new-born, while evidence regarding the risk of preterm labour, low birth weight, low Apgar score, prolonged QT interval and miscarriage is less clear” and continues, explaining “An estimated 20-30% of infants will have neonatal symptoms following intrauterine SRI exposure.” (emphasis added)

It is noted that “infants may exhibit neurological, gastrointestinal, autonomic, endocrine or respiratory symptoms. Although the symptoms are self-limited, the families may be seriously affected” and warned that “Until sufficient safety studies have been carried out, SRI must be used with caution in pregnancy and every treatment of the pregnant woman should be thoroughly considered.”

Due to the fact that many SSRI drug manufacturers have failed to provide adequate warning labels that include information on risks for congenital malformations and neonatal adaptation syndrome, a number of SSRI birth defects 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 neonatal adaptation syndrome, 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.

An article published March 11, 2014 in BJOG: an international journal of obstetrics and gynaecology by L. Ban et al., a team from The University of Nottingham in the United Kingdom, titled “Maternal depression, antidepressant prescriptions, and congenital anomaly risk in offspring: a population-based cohort study.” provides insight into the connection between neonatal exposure to selective serotonin reuptake inhibitor (SSRI) drugs and birth defects by means of a large, population-based study.

The stated objective of this study was “To estimate risks of major congenital anomaly (MCA) among children of mothers prescribed antidepressants during early pregnancy or diagnosed with depression but without antidepressant prescriptions”, and in all, just shy of 350,000 children born between 1990 and 2009 were studied.

The most shocking finding of this study was that paroxetine (Paxil) exposure was significantly associated with an increased risk for heart defects: “Paroxetine was associated with increased heart anomalies (absolute risk 1.4% in the exposed group compared with 0.8% in women without depression; aOR 1.78, 95% CI 1.09-2.88), which decreased marginally when compared with women with diagnosed but unmedicated depression (aOR 1.67, 95% CI 1.00-2.80).”

This means that babies born to mothers who used Paxil during pregnancy were found to be 78% more likely to be born with a heart defect (if the mother was not depressed), and 67% more likely than if the other was depressed but unmedicated.

Because the manufacturer of Paxil has time and again failed to adequately notify women of the risk for heart defects associated with paroxetine, a number of Paxil® birth defect lawsuits have been filed.

If you or a loved one used Paxil and gave birth to a child with a heart defect or another congenital malformation, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Paxil® birth defects 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.

A 2011 article published in that year’s December edition of the medical journal Reproductive Toxicology provides a bit of deeper insight into the connection between prenatal exposure to selective serotonin reuptake inhibitors (SSRIs) and heart defects.

In the article, titled “Selective serotonin reuptake inhibitors (SSRIs) and heart defects: potential mechanisms for the observed associations.”, T.W. Sadler writes that serotonin is not only a neurotransmitter, but also “acts as a signaling molecule during embryogenesis affecting cell proliferation, migration, death, and differentiation. Serotonin may be particularly important for heart development and evidence suggests that from the time that progenitor heart cells are patterned during the establishment of laterality, to formation of the outflow tract, to myocardial cell differentiation, to septation of the heart chambers, the neurotransmitter may act as an important signaling molecule.”

The author goes on, stating “Thus, numerous investigations have identified potential target sites where serotonin could regulate key cellular processes in cardiac development, thereby providing biological plausibility for the origin of heart defects caused by SSRIs.”

This article is important in two ways.  First, it helps unravel how SSRI drugs could be linked to heart malformations.  Second, it takes for granted that SSRI drugs are linked to heart malformations, illustrating the cohesion within the medical community surrounding this topic.

Because many women have used SSRIs during pregnancy unaware of the risk for heart birth defects, a number of SSRI Birth Defects Lawsuits have been filed.

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

Since the early 1990s, scientists and medical researchers have found that finasteride use is linked to sexual dysfunction in the form of erectile dysfunction, loss of libido, ejaculation disorder, and other ailments.  This chemical is the active chemical in the hair loss drug Propecia (finasteride 1mg) and the benign prostatic hyperplasia (BPH) drug, Proscar (finasteride 5mg).

A 2001 article by C. Schulman in Prostate Cancer and Prostatic Diseases titled “Impact of treatment of BPH on sexuality.” states “The 5alpha-reductase inhibitor, finasteride, can result in ED in 5-9% of patients and ejaculation disorders in 0.8-2.0%.”  This rate of erectile dysfunction is significantly higher than that reported by Merck & Co., Inc., the manufacturer of Proscar.  Schulman asserts “In addition to information on the efficacy of a particular therapy, patients should be informed of side effects, in particular those relating to sexual function, in order that they can make informed treatment decisions.”  I couldn’t agree more.

An article titled “Finasteride in the treatment of clinical benign prostatic hyperplasia: a systematic review of randomised trials.” published by JE Edwards and RA Moore of the Pain Research and Nuffield Department of Anaesthetics at The University of Oxford in BMC Urology in 2002 also studied the connection between sexual dysfunction and Proscar.  The authors write “Significantly more sexual dysfunction, impotence, ejaculation disorder and decreased libido occurred with finasteride at 12 months; the NNH for any sexual dysfunction at 12 months was 14” in a study that reviewed nearly 9,000 finasteride and 6,000 control patient files from other studies.  An “NNH” of 14 means that in the first year of study, one of every 14 patients using Proscar will suffer sexual dysfunction (who wouldn’t if the drug was not used).

In 2000, an article titled “Medical therapy for benign prostatic hyperplasia: a review of the literature.” appearing in the July edition of European Urology makes a brief albeit important reference to the link between sexual dysfunction and Proscar.  Studying a variety of treatments for BPH, the research team remarks (led by GM Clifford), “They are, however, both associated with an increased risk of sexual dysfunction,” referencing finasteride (Proscar) and tamsulosin (Flomax).

All of these papers were published more than ten years before the manufacturer sufficiently updated warning labels.  Due to the fact that Merck & Co., Inc. failed to adequately warn users of the risk for sexual side effects, a number of Proscar lawsuits have been filed.  If you or a loved one used Proscar and suffered sexual side effects, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Proscar 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