June 2014

The June, 2004 edition of Journal of Perinatology presented a study titled “Transient neonatal jitteriness due to maternal use of sertraline (Zoloft).” by R.P. Santos et al., providing important insight into the link between Zoloft expousre during pregnancy and adverse birth outcomes.  Here is the abstract of that article:

“We describe the occurrence of marked jitteriness and an enhanced startle response in a term infant after being exposed to sertraline in utero. An umbilical cord blood sample taken at the time of birth showed a sertraline concentration (<10 ng/mL) below the reference range. On the third day during the peak of the symptoms, sertraline plasma concentration was <10 ng/mL, while his serotonin level (6 ng/mL) was below the reference range. The neurologic symptoms resolved by the fifth day. To date, there are no reports of transient neonatal jitteriness with maternal use of sertraline documented with low cord and neonatal plasma samples consistent with withdrawal syndrome.”

Because so many women have used Zoloft during pregnancy unaware of the risks for Zoloft birth defects, a great number of Zoloft® birth defects lawsuits have been filed.  If you or a loved one used 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 Zoloft® 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 2008, a team of Dutch researchers led by D.L. Van den Hove published a study in Neonatology titled “Prenatal maternal paroxetine treatment and neonatal mortality in the rat: a preliminary study.” evaluating the perinatal effects of gestational exposure to Paxil (paroxetine).

These researchers write, “Recent evidence has shown that prenatal maternal stress has negative consequences for the mental health of the adult organism. Our aim was to examine the efficacy of using the selective serotonin reuptake inhibitor, paroxetine, to alleviate the symptoms of prenatal maternal stress in Fisher 344 rats.”

Subjecting pregnant rats to daily stress and Paxil treatment during the last week of pregnancy, the team found that “Maternal paroxetine treatment led to a shortened gestational length, reduced birth weight and a 10-fold rise in neonatal mortality in both stressed and non-stressed litters.”

Accordingly, the team concluded that “These results reiterate the need for further research on the effects of paroxetine treatment during gestation.”

Unfortunately, many women have used Paxil during pregnancy unaware of these risks, and a number of Paxil® birth defect lawsuits have been filed as a result.  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.

Today, I came across an article from the March, 2011 edition of Journal of Population Therapeutics and Clinical Pharmacology titled “The effect of ascertainment bias in evaluating gestational antidepressant exposure.” that helps illustrate the link between gestational exposure to selective serotonin reuptake inhibitor drugs and birth defects, heart defects in particular.

Here is the abstract of that article, by G. Koren, a researcher from the University of Toronto:

“Several administrative database studies have reported on a positive association between first trimester exposure to paroxetine and ventricular septal defects (VSD). Using multiple source data we have shown that depressed women utilize significantly more health care resources, including ultrasound, echocardiogram and emergency room visits for their babies. Hence, there is much higher chance to identify VSD in their babies than among healthy controls. Moreover, paroxetine has been used more specifically than other SSRI for anxiety, further increasing the chance of  ascertainment bias.”

The birth defect discussed, ventricular septal defect (VSD) , is a heart defect wherein a hole between the left and right ventricles of the heart fails to close after birth, resulting in a mixing of oxygen-rich and oxygen-poor blood and thus a decreased overall blood oxygen level.  Many other researchers have linked SSRI exposure (particularly Paxil exposure) before birth and VSD.

Because many expecting mothers have used SSRIs unaware of the risk for birth defects, 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 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.

Researching the connection between prenatal Prozac exposure and birth defects this morning, I found an article by D.J. Goldstein et al., titled “Effects of first-trimester fluoxetine exposure on the newborn.”  This article, appearing in the May, 1997 edition of Obstetrics and Gynecology, provides important insight into the connection between gestational SSRI exposure and adverse birth outcomes and spontaneous abortion.

Studying 796 pregnancies, the team found that “Spontaneous abortions were reported in 110 of the 796 (13.8%) pregnancies. Of the remaining 686, malformations, deformations, and disruptions, including those identified after the perinatal period, were reported in 34 (5.0%).”

Since the time this study was published, a number of other medical research teams have linked SSRI exposure and birth defects, and sadly, the manufacturers of drugs like Prozac have failed to warn women of these risks.  Because of this, a number of SSRI birth defect lawsuits have been filed.

If you or a loved one used Prozac 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 Prozac® 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 read a 1996 study by a team from Georgetown University published in Harvard Review of Psychiatry titled “Selective serotonin-reuptake inhibitors in pregnancy and lactation.”, that provides good insight into the state of research into the SSRI-birth defect link nearly two decades ago.

Of their research, the team led by A.L. Baum, states “We explore the effects on the developing fetus and neonate of selective serotonin-reuptake inhibitors (SSRIs) during pregnancy and lactation, reviewing the relevant animal and human studies published in English from 1976 to the present.”

At that time, “Animal studies were inconclusive: some found that fetal exposure to high doses of fluoxetine produced no congenital anomalies, while others linked the drug to abnormalities such as craniofacial malformations, alterations in serotonergic neurotransmitter systems, birth-related hematomas, and inhibition of the milk-ejection reflex.”  These findings have been replicated by numerous other studies linking SSRIs and birth defects.

Baum continues, “we found a suggestion of an increased rate of miscarriage, an association with infants large for gestational age, one reported case of perinatal toxicity, and one case of an infant who was colicky while receiving breast milk from a mother taking fluoxetine. Based on these data, controlled prospective studies of exposure to SSRIs during pregnancy and lactation are needed, as is long-term evaluation for behavioral teratogenesis and enduring cognitive effects. Data are lacking on drug levels in breast milk and neonatal serum. Neonatal toxicity and the effect of SSRIs on labor and delivery, the mother-infant interaction, and lactation also merit further study. Clinically, a conservative approach is encouraged, minimizing the use of SSRIs in pregnancy, avoiding such drugs during the first trimester, tapering them prior to delivery, and discouraging breast-feeding during their use.”

Due to the fact that a number of expecting mothers have used SSRI drugs unaware of these risks, 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 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.

Recently, I found an article titled “Birth outcomes in pregnant women taking fluoxetine.”, appearing in the October 1996 edition of The New England Journal of Medicine, amounting to one of the oldest articles studying the link between gestational Prozac exposure and adverse birth outcomes.  Over the past two decades, many studies have been published linking SSRIs and birth defects or otherwise negative perinatal outcomes.

Accordingly, the team writes, “Although fluoxetine is the most frequently prescribed antidepressant drug in the United States, its safety in pregnant women has not been established.”

Results of this small study showed that “Among the 97 infants exposed to fluoxetine who were evaluated for minor anomalies, the incidence of three or more minor anomalies was significantly higher than among 153 similarly examined control infants (15.5 percent vs. 6.5 percent, P=0.03).”

Chambers et al. (1996) continue: “As compared with the 101 infants exposed to fluoxetine only during the first and second trimesters, the 73 infants exposed during the third trimester had higher rates of premature delivery (relative risk, 4.8; 95 percent confidence interval, 1.1 to 20.8), admission to special-care nurseries (relative risk, 2.6; 95 percent confidence interval, 1.1 to 6.9), and poor neonatal adaptation, including respiratory difficulty, cyanosis on feeding, and jitteriness (relative risk, 8.7; 95 percent confidence interval, 2.9 to 26.6). Birth weight was also lower and birth length shorter in infants exposed fluoxetine late in gestation.”

That means that babies exposed to Prozac before birth were more likely to have minor birth defects, premature birth, low birth weight, poor neonatal adaptation, require special-care nursery, and other negative birth outcomes.

Because so many women have taken Prozac during pregnancy unaware of the risks posed to the developing fetus, a number of Prozac birth defect lawsuits have been filed.

If you or a loved one used Prozac 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 Prozac® 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.

A subpoena is a court order telling someone to appear at a legal proceeding or to produce certain documents. Generally, if someone is subpoenaed, that person must comply. In other words, the person must appear at the place and time designated in the subpoena, and if the subpoena requires the production of certain documents, the person is legally bound to produce them.

Courts’ subpoena power comes from Federal Rule of Civil Procedure 45 which states that ‘‘[e]very subpoena shall . . . command each person to whom it is directed to attend and give testimony or to produce and permit inspection . . . of designated . . . documents.’’

Generally, if one fails to appear as ordered by the subpoena, or fails to produce the requested documents, he or she will likely be found in contempt of court and sanctioned with jail time and fines. Of course, there are a few well known exceptions to this rule that one must testify or produce documents if subpoenaed.

First, one may have the right to refuse to answer questions or produce documents if doing so might incriminate oneself in a crime. Second, one may also refuse to testify if answering the question or producing the document violates a legally-recognized privilege, such as a marital privilege, an attorney-client privilege, or a doctor-patient privilege.

However, there is another, less commonly known exception to the “subpoena rule.” If one is a federal employee, he or she may avoid testifying or producing requested documents due to something called “Touhy regulations,” named after the landmark case, United States ex rel. Touhy v. Ragen, 340 U.S. 462 (1951).

Under federal Touhy regulations, federal employees generally cannot be compelled to testify or produce documents even when they have extremely relevant information. Such employees testify and disclose information only if the federal agency ultimately agrees it is in the agency’s best interest. Awfully convenient for the federal agency—and awfully inconvenient for the party trying to establish facts by having federal employees testify or disclose certain documents.

Since the FDA is a federal agency, Touhy regulations are a good thing to be aware of if you bring a lawsuit involving pharmaceutical companies and defective medicines. Since federal employees of the FDA may be key witnesses to your claims, Touhy regulations can certainly present a challenge. Every agency has its own Touhy regulations, and therefore it is important to check the FDA’s specific regulations to determine what steps need to be taken to overcome the regulations and acquire the testimony or documents that you need.

Typically, an agency’s Touhy regulations’ first step requires you to submit a formal written request identifying which federal employees you want as witnesses and the areas of testimony. Despite the obstacles that Touhy regulations may present, our firm remains determined to help you navigate the steps involved in your potential case and successfully serve a subpoena on a federal agency if need be.  Please call us for a free consultation.

 

In 1996, C.D. Chambers et al. published a study titled “Birth outcomes in pregnant women taking fluoxetine.” in The New England Journal of Medicine studying the effects of prenatal exposure to Prozac (fluoxetine).  Many studies since have demonstrated that babies born to mothers who used Prozac before birth are much more likely to be born with a congenital malformation or have adverse birth outcomes.

The team writes “From 1989 through 1995, we prospectively identified 228 pregnant women taking fluoxetine. We compared the outcomes of their pregnancies with those of 254 women identified in a similar manner who were not taking fluoxetine.”

After statistical analysis, the results showed that 5.5% of babies exposed to Prozac were born with malformations compared with 4% of control subjects.  Also, “Among the 97 infants exposed to fluoxetine who were evaluated for minor anomalies, the incidence of three or more minor anomalies was significantly higher than among 153 similarly examined control infants (15.5 percent vs. 6.5 percent, P=0.03). As compared with the 101 infants exposed to fluoxetine only during the first and second trimesters, the 73 infants exposed during the third trimester had higher rates of premature delivery (relative risk, 4.8; 95 percent confidence interval, 1.1 to 20.8), admission to special-care nurseries (relative risk, 2.6; 95 percent confidence interval, 1.1 to 6.9), and poor neonatal adaptation, including respiratory difficulty, cyanosis on feeding, and jitteriness (relative risk, 8.7; 95 percent confidence interval, 2.9 to 26.6).Birth weight was also lower and birth length shorter in infants exposed fluoxetine late in gestation.”

Demonstrating that medical professionals had established prenatal Prozac exposure was linked to malformations, premature delivery, the need for special postnatal care, and adaptation difficulties, this paper can be used in a Prozac® birth defects lawsuit.  Because many women have used Prozac unaware of these risks, many such Prozac® birth defects lawsuits have been filed.

If you or a loved one used Prozac 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 Prozac® 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.

Searching the phrase “sertraline malformation” in PubMed, an online medical literature database curated by the US National Library of Medicine and National Institutes of Health, this morning I came across an article titled “Serotonin as a regulator of craniofacial morphogenesis: site specific malformations following exposure to serotonin uptake inhibitors.” by D.L. Shuey et al., appearing in the October, 1992 edition of Teratology.  To be clear, “sertraline” is the chemical name for the selective serotonin reuptake inhibitor (SSRI), Zoloft®.

Studying mice, the team found that “Exposure of mouse embryos in whole embryo culture to sertraline, at a concentration (10 microM) which produced no evidence of general embryotoxicity, caused craniofacial malformations consistent with direct action at 5-HT uptake sites. Two other 5-HT uptake inhibitors, fluoxetine and amitriptyline, produced similar defects.”

Many other studies published in recent decades have also linked prenatal SSRI exposure to craniofacial malformations such as cleft lip and cleft palate. The researchers concluded “it appears that inhibition of 5-HT uptake into craniofacial epithelia may produce developmental defects by interference with serotonergic regulation of epithelial-mesenchymal interactions important for normal craniofacial morphogenesis.”

Because so many women have used SSRIs unaware of the risks associated with gestational exposure to selective serotonin reuptake inhibitors, a number of SSRI 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 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.

Here, I present two studies I read this morning concerning the connection between prenatal SSRI exposure and adverse perinatal outcomes.  selective serotonin reuptake inhibitor drugs (SSRIs) are widely used for a range of psychiatric ailments from depression to anxiety and work by regulating the concentration of serotonin molecules in the synapses between neurons.  Serotonin is a neurotransmitter that plays a large role in mood, appetite, and sleep regulation, and also in fetal development, particularly in the development of the heart.  This is why many scientific studies have linked early pregnancy SSRI exposure to cardiac malformations.

First to be discussed, the findings of an Australian research team concerning neonatal seizures for babies exposed to SSRIs in pregnancy.  In their study titled, “Neonatal seizures from in utero venlafaxine exposure.” and published in Journal of Paediatrics and Child Health (November 2006), RK Pakalapati et al. write “We present a report of two infants with neonatal seizures attributed to maternal use of venlafaxine.”  To be clear, venlafaxine is the chemical name for the popular antidepressant, Effexor.

The team continues, “The first infant was hypotonic and required resuscitation at birth. The second was born in a good condition but developed clinically apparent seizures after the second day of life.”

Stating that “Other causes of neonatal seizures were excluded and neurological investigations on these two infants were unremarkable”, Pakalapati et al. (2006) suggested that “all infants exposed to maternal venlafaxine, no matter their condition at birth, be monitored in hospital for at least 3 to 4 days in order to preempt and treat adverse neurological events.”

Next, a study that demonstrates the presence of SSRIs in amniotic fluid.  It has long been known that SSRIs may cross the placenta, but here we see SSRIs may access fetus, if you will, by other means.  In this article titled “Antidepressants in amniotic fluid: another route of fetal exposure.” by AM Loughhead et al., appearing in American Journal of Psychiatry, this team of researchers from Emory University School of Medicine studied amniotic fluid from 27 women, finding that “the amniotic fluid’s antidepressant concentrations were highly variable. For the parent compounds, the amniotic fluid concentrations of selective serotonin uptake inhibitors averaged 11.6% (SD=9.9%) of maternal serum concentrations (N=22). Amniotic fluid to maternal serum ratios were higher for venlafaxine: 172% (SD=91%) (N=3).”

As such, the team writes, “The pattern of antidepressant concentrations in amniotic fluid is similar to recent data for placental passage. Although the significance of amniotic fluid exposure remains to be determined, these results demonstrate that maternally administered antidepressants are accessible to the fetus in a manner not previously appreciated.”

Because many women have used Effexor unaware of the risk for adverse birth outcomes, a number of Effexor® birth defects lawsuits have been filed.  If you or a loved one used Effexor 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 Effexor® 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.