The plaintiffs allege that their children were born with varying birth defects including heart defects, neural tube defects, gastroschisis, omphalocele, craniosynostosis, cleft lip, club foot, anal atresia, and limb reduction defects. They blame the drug.

“Pfizer knew or should have known that Zoloft crosses the placenta, which could have important implications for the developing fetus,” the lawsuit states. The plaintiffs allege that Pfizer instead marketed Zoloft as the safest antidepressant to take during pregnancy.

Zoloft is in a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. Other drugs in this class include Paxil, Celexa, Lexapro, and Prozac. All SSRIs were classified as Category C pregnancy drugs, meaning that no studies have proven risks to developing fetuses. However, recent studies proving Paxil causes birth defects have required the reclassification of Paxil to a Category D pregnancy drug.

SSRIs are among the most prescribed medications in the country, and drug companies make millions off these drugs. The plaintiffs in the Zoloft lawsuit claim that Pfizer kept reports of complications in fetuses under wraps to protect its empire. The drug maker disputes these claims.

The lawsuit alleges strict products liability, breach of express warranty, negligence, misrepresentation by omission, negligent misrepresentation, fraud and misrepresentation, fraud by concealment, violation of consumer protection laws, and breach of implied warranties. The lawsuit seeks unspecified compensatory damages, statutory remedies, a disgorgement of profits and pre-judgment interests.

Attorneys with Beasley Allen Law Firm are currently investigating cases of birth defects allegedly associated with Zoloft and any other SSRI.

Source: The Madison St. Clair Record

SOURCE: Paxil and Pregnancy › Parents file birth defects lawsuit against makers of Zoloft

Pregnant women

The study involved nearly 3,000 women who gave birth in Washington state. Researchers found that those who started taking antidepressants known as selective serotonin reuptake inhibitors, or SSRIs, in the second or third trimester were nearly five times more likely to give birth prematurely compared to pregnant women not on the medication.

SSRIs are prescribed for the treatment of depression and anxiety disorders and include drugs such as Zoloft (sertraline), Paxil (paroxetine), and Prozac (fluoxetine).

The study raises more concerns about the safety of SSRIs during pregnancy. A New England Journal of Medicine study found that women who took SSRIs during their third trimester were six times more likely to deliver babies born with persistent pulmonary hypertension (PPHN), a serious lung condition, than those who did not take SSRI during their third trimester.

More studies have linked SSRIs to omphalocele, a birth defect where the intestine or other abdominal organs protrude from the naval. Other birth defects that have been reported include cleft palate, club foot, spina bifida, anal atresia, and congenital heart defects.

Beasley Allen Law Firm is currently investigating cases of birth defects and birth complications  allegedly caused by SSRI use during pregnancy. These lawsuits may provide the financial resources necessary for a lifetime of care or to help pay for medical procedures for babies that may have been affected by the drugs.

Source: American Journal of Obstetrics & Gynecology

SOURCE: Paxil and Pregnancy › Study links SSRIs to preterm delivery and birth complications

GlaxoSmithKline

Paxil is a type of medication known as selective serotonin reuptake inhibitors (SSRIs), and is prescribed for the treatment of depression and anxiety disorder. Other brands of SSRIs include Zoloft, Lexapro, Prosac and Celexa. Paxil is considered more toxic to unborn babies than any other SSRI, and is listed as a Category D drug. All other SSRI drugs are Category C drugs, meaning they are safer for use during pregnancy.

Since 2005, studies have linked Paxil to birth defects including cardiac (heart) defects, pulmonary (lung) defects, neural tube defects (brain and spinal cord), craniosynostosis (abnormally shaped skull), infant omphalocele (abdominal wall defects), club foot (one or both feet turn downward and inward), and anal atresia (complete or partial closure of the anus).

Newer studies also have linked the antidepressant to an increased risk of Neonatal Persistent Pulmonary Hypertension (PPHN).

More recent studies have also linked serious birth defects with other types of SSRIs, which has led some people to question whether all SSRIs should be labeled as Category D drugs and avoided during pregnancy.

Anyone who has taken an SSRI during pregnancy and delivered a child with a birth defect may have a case against the drug’s maker.

SOURCE: Paxil and Pregnancy › Millions awarded to women in Paxil, birth defects lawsuits

Christine K had been prescribed a combination of Paxil, Risperdal and Depakote five years prior to becoming pregnant. While pregnant she read that Paxil could be harmful to her unborn baby. She asked her doctor take her off the meds, but he insisted she stay on them.

Christine K did more research on the medications and learned that a scientific study on infants born to women taking antidepressants during the first trimester of pregnancy showed that women who took Paxil had a greater risk of birth defects compared to other antidepressants.

As a result of the study, in 2005, GlaxoSmithKline informed health care professionals that it was updating the precautions section of the label for its antidepressant Paxil to include the risk of birth defects and, in particular, heart defects.

In 2006, the Food and Drug Administration (FDA) released another Public Health Advisory based on another study that indicated additional risks associated with taking antidepressants during pregnancy including persistent pulmonary hypertention (PPHN), a serious and life-threatening lung condition that occurs soon after birth, omphalocele and craniosynostosis.

Six months into her pregnancy, against her doctor’s orders, Christine K heeded the warning signs she had read about online and weaned herself off Paxil and the other antidepressants. But the damage had already been done. While her son doesn’t have any of the above mentioned severe birth defects, he does experience sleep problems, aversions to eating, and overall poor health.

“In the first three years of his life, this child has needed more medical care and doctor’s appointments than my other three children combined,” she told the Dissident Voice. “All I can do is watch and wait and hope (his medical problems) resolve on their own.”

SOURCE: Paxil and Pregnancy › Child is helpless victim of mother’s use of Paxil during pregnancy

The company cited newly analyzed data from a retrospective epidemiologic study of major congenital malformations in infants, saying that “preliminary results suggest an increase in the risk of congenital malformations associated with the use of paroxetine as compared to other antidepressants.”

Changes in the drug’s labeling are being made after consultation with the U.S. Food and Drug Administration (FDA).

Current FDA-approved labeling lists paroxetine as a pregnancy Category C drug. Category C is defined as drugs with “no adequate and well-controlled studies in humans to determine the effect on the fetus.” Current labeling reminds prescribers that paroxetine during pregnancy should be used only if the potential benefit justifies the potential risk.

Information will be added to the product label indicating that of 3,581 pregnant women exposed to paroxetine or other antidepressants during the first trimester, use of paroxetine, compared with other antidepressants, was associated with an “increased risk of overall major congenital malformations.”

Specifically, women who took paroxetine were 2.2 times more likely to give birth to an infant with a major congenital malformation and 2.08 times more likely to give birth to an infant with a cardiovascular malformation than women on other antidepressants. Of 14 infants with a major congenital malformation born to women taking paroxetine, 10 of those with cardiovascular malformations had ventricular septal defects.

The new labeling goes on to note that a separate study based on the Swedish Medical Birth Registry “evaluated 4,291 infants exposed to SSRIs in early pregnancy. This study reported no increased risk for overall major malformations in 708 infants born to women with paroxetine exposure early in pregnancy.”

In the company’s “Dear Healthcare Provider” letter regarding the new labeling, GSK said that “it is important to note that because the GSK study was designed to evaluate the relative risk of congenital malformations in infants born to women exposed to antidepressants, the study did not include a comparison to infants who were not exposed to any antidepressant. Therefore, these data should be viewed within the context of the overall prevalence of congenital malformations in the general population, which is estimated in the U.S. to be approximately 3 percent for any malformation, and approximately 1 percent for cardiovascular malformations alone.”

GSK reviewed other epidemiological studies of SSRI exposure during pregnancy in its “Dear Healthcare Provider” letter, as well as several case-control studies. In addition, it cited the National Birth Defects Prevention Study of infants delivered from 1997 through 2001.

In that study, women who took any SSRI were more likely than those who were not exposed to have an infant with omphalocele.

The strongest effect was reported in that study to be with paroxetine, which accounted for 36 percent of all exposures to an SSRI. Infants born to mothers taking paroxetine during the first trimester were found to be 6.3 times more likely to have an omphalocele compared with infants born to mothers who took no SSRIs. An association was also found between SSRI exposure and infants being born with craniosynostosis.

GSK concluded, “The differences in the results from the available studies and the diversity in type of abnormalities recently reported makes it difficult to definitively conclude a causal relationship for any particular congenital abnormality with paroxetine.”

The company, in cooperation with FDA requests, is conducting additional epidemiologic studies “to more fully understand these preliminary findings.”

SOURCE: Paxil and Pregnancy › New Paxil Labeling Warns Of Birth-Defect Risk