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Mass Torts Attorneys > Antidepressants – Birth Defects

  • Prozac (fluoxetine, Eli Lilly)
  • Zoloft (sertraline, Pfizer)
  • Paxil (paroxetine, GlaxosSmithKline)
  • Celexa (citalopram, Forest Laboratories)
  • Lexapro (escitalopram, Forest Laboratories)
  • Effexor (venlafaxine, Pfizer)
  • Pristiq (desvenlafaxine, Pfizer)

Pregnant women taking antidepressants could face a double blow: Dealing with their own depression, plus the tragedy of a newborn child with life-threatening birth defects.

One of the most devastating heartbreaks for parents is news that their newborn has a serious birth defect or medical condition. Even worse is learning that the child’s condition may be caused by medications that the mother innocently took during her pregnancy.

For a new mother, this is a double tragedy: The depression that she sought to alleviate is compounded by a beloved infant’s life foreshortened, or severely limited, by heart abnormalities, breathing difficulties, birth defects, and/or developmental problems.

Evidence is mounting from the medical and scientific community that the classes of antidepressants called Selective Serotonin Reuptake Inhibitors (SSRIs) and Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) are connected with serious birth defects such as:

  • Atrial/septal defects,abnormal formation of tissue that separates one chamber of the heart from the other
  • Other cardiac (heart) defects and congenital malformations
  • Persistent pulmonary hypertension (PPH), in which high pressure in the blood vessels of the lung makes it hard for newborn babies to breathe and an estimated 10% to 20% of infants do not survive
  • Autism spectrum disorder, neurological disorders resulting in complex developmental disabilities related to social interaction and communication skills
  • Neural-tube defects (brain and spinal cord)
  • Craniosynostosis (skull defects)
  • Infant omphalocele (abdominal wall defects)
  • Clubfoot (one or both feet turn downward and inward)
  • Anal atresia (complete or partial closure of the anus)
  • Cleft lip and cleft palate
  • Limb defects (arms and/or legs)
  • Premature births

The culprits that cause these congenital birth defects are some of the best-known household names in antidepressants: Prozac, Zoloft, Paxil, Celexa, Lexapro, Effexor, and Pristiq.

As early as the mid-2000s, there were suspicions that taking SSRI antidepressants during pregnancy could be unsafe, especially in the first trimester.

When SSRI antidepressants first appeared on the market in the late1980s and early 1990s, they were welcomed as magic by people suffering from conditions such as major depressive disorder, obsessive compulsive disorder, panic disorder, and eating disorders such as bulimia. Serotonin is a transmitter in the brain that affects mood, sleep, learning, and constriction of blood vessels, and can impact anxiety and appetite. SSRI antidepressants work by preventing serotoninfrom being reabsorbed by the nerve cell that released it. This forces the serotonin to remain active, which relieves depression in some people.

Medical scientists estimate that depression affects between 10% and 25% of women during their lifetime, with peak risk during the child-bearing years. As SSRI antidepressants became increasingly popular, prescription use increased from 1.5%of pregnant women in 1996 to 6.4% of pregnant women in 2004. Knowing that SSRIs such as Paxil and Prozac can readily cross the human placenta, researchers began years ago to investigate the possibility that SSRI antidepressant use during pregnancy was connected to congenital birth defects and developmental delays.

Here’s what they found:

  • In February 2006, the New England Journal of Medicine published results of a large case-controlled epidemiologic study conducted by the University of California at San Diego, the Slone Epidemiology Center at Boston University, and the Children’s Hospital and Brigham & Women’s Hospital at Harvard Medical School. Consistent with previous observations in a smaller study, researchers concluded that exposure to an SSRI after the 20th week of pregnancy significantly increased the risk of persistent pulmonary hypertension (PPH). There was no increase in risk of PPH demonstrated in this study with SSRI use during the first half of pregnancy.
  • In June 2007, the NEJM published a Slone Epidemiology Center Birth Defects Study indicating that, while first trimester use of SSRIs may be connected to development of birth defects in general, specific drugs yield differing defects. This study established a correlation between Zoloft and septal defects – affecting tissue separating the chambers of the heart. It also identified a connection between Paxil and obstructions in the right ventricular outflow tract in the heart – the path through which blood flows to the pulmonary artery. Both of these conditions are devastating to a child and require numerous surgeries.
  • In August 2008, the British Journal of Clinical Pharmacology reported results of a multicentre, controlled observational study by Teratology Information Services in Israel, Italy, and Germany, and the Hadassah Medical School at the Hebrew University in Jerusalem. This study suggested that pregnant women taking Paxil or Prozac in their first trimester double their risk of having an infant with congenital cardiovascular anomalies.

Recent studies offer new evidence that taking SSRI antidepressants at any time during pregnancy may be dangerous, and should be considered only when the potential benefits to a woman outweigh the potential risks to her baby:

  • Echocardiographic screening of newborns with persistent heart murmurs, reported in June 2009, found a two-fold higher risk of heart defects among infants exposed to Paxil and Prozac during the first trimester, compared to infants not exposed. This research was conducted by medical scientists at the Rabin Medical Center, Beilinson Teratology Information Service, Sackler Faculty of Medicine, and Schneider Children’s Medical Center of Israel.
  • A population-based cohort study released in 2009 of 493,113 infants born in Denmark between 1996 and 2003 concluded that exposure to SSRIs in early pregnancy increased prevalence of septal heart defects, especially with Zoloft, Celexa, and Prozac.
  • An updated analysis published in Clinical Epidemiology of selective SSRIs and the risk of congenital malformations concluded that use in early pregnancy could be related to ingestion of antidepressants, specifically tracing septal defects to Zoloft.
  • A July 2011 report published online in the Archives of General Psychiatry highlighted emerging research connecting SSRI antidepressants with autism spectrum disorders (ASDs). Researchers noted that increased prevalence of ASDs has paralleled increased use of antidepressants during pregnancy. Their population-based, case-control study at Kaiser Permanente Medical Care Program in Northern California suggested a two-fold increased risk of autism spectrum disorders associated with use of SSRI antidepressants during pregnancy. The strongest correlation was associated with exposure in the first three months of pregnancy.

Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) were introduced a little later than the SSRI antidepressants: Effexor in 1993, and Pristiq in 2008. They are essentially the same drug, and are prescribed for some of the same depression-related symptoms that are treated with SSRIs.

Effexor is approved by the FDA for treating major depressive disorder, generalized anxiety disorder, panic disorder, and social anxiety disorder. To date, Pristiq has been approved by the FDA only to treat major depressive disorder.

Pfizer, the manufacturer of both Effexor and Pristiq, alleges that they are more effective than SSRIs in combating depression because they inhibit the reuptake of both serotonin and norepinephrine. Norepinephrine is both a neurotransmitter and a hormone, secreted in the sympathetic nervous system, the brain, and the adrenal glands. Some studies indicate that norepinephrine may be associated with an elevated manic state.

There are few studies demonstrating the side effects of ingesting these SNRIs during pregnancy. However, both Effexor and Pristiq are listed by the FDA in pregnancy Category C, meaning that animal studies have shown adverse effects on the fetus. Some research indicates that newborns exposed to Effexor in the third trimester of the mother’s pregnancy are at greater risk of breathing difficulties, seizures, feeding difficulties, and low blood sugar – and may be more likely to require hospitalization, feeding tubes and supplemental oxygen.

The FDA first alerted pregnant women to the dangers of Paxil in December 2005. A year later, the agency mandated a class-wide label change for all SSRI antidepressants to reflect the dangers of use in the first trimester. But SSRI and SNRI manufacturers have yet to respond to recent, more definitive research correlating use of their antidepressants by pregnant women with various birth defects and developmental disorders. 

The FDA divides SSRI and SNRI antidepressants into five categories related to safe use during pregnancy:

  • Category A means that “adequate and well-controlled studies” fail to demonstrate risk in either the first or later trimesters of pregnancy.
  • Category B notes that animal reproduction studies do not demonstrate risk to the fetus, and there are no adequate, well-controlled studies in pregnant women.
  • Category C indicates that animal reproduction studies indicate an adverse effect, but there are no adequate, well-controlled human studies, and potential benefits may warrant use of the drug by pregnant women despite potential risks.
  • Category D admits positive evidence of human fetal risk in studies on humans, but also notes that potential benefits may warrant use despite potential risks for pregnant women.
  • Category X confirms demonstrated fetal abnormalities and/or positive evidence of human fetal risk and states that the risks to pregnant women clearly outweigh potential benefits.

Prozac, Zoloft, Celexa and Lexapro – as well as Effexor and Pristiq - currently are categorized by the FDA as Category C; only one drug, Paxil, is included in Category D at this time.  Consumer advocates and some members of the medical community are lobbying the FDA to move all of these drugs into Category D because recent studies demonstrate “positive evidence of risk in human studies” with use of these other antidepressants, as well as with Paxil.

In the meantime, prescribing information for Prozac and Paxil includes warnings about first-trimester use and an increased risk of congenital cardiovascular malformations. Prescribing information for Prozac, Zoloft, Paxil, Celexa, Loxapro, Effexor and Pristiq all contain warnings that exposure in late pregnancy may carry an increased risk for persistent pulmonary hypertension (PPH) in a newborn, other birth defects, and/or developmental difficulties.

Click on each drug’s name below to view its current package labeling, including warnings about ingestion during pregnancy:

Given the research evidence and FDA warnings, it should come as no surprise that multiple lawsuits related to birth defects have been filed against GlaxoSmithKline, the makers of Paxil. To date, the company has paid out more than $2 billion in verdicts and settlements, and new cases are still being filed against the manufacturers of Paxil. There is also emerging litigation against the manufacturers of Prozac, Zoloft, Celexa, Lexapro, Effexor, and Pristiq in light of new evidence also linking ingestion of these antidepressants by pregnant women to various birth defects.

The moral of the story of SSRI and SNRI antidepressants goes beyond the perilous impact of these specific medications. The message is a broader one: just because a drug is approved by the FDA doesn’t mean it is safe.

No drug should be taken without research and discussion with a trusted physician. And no drug manufacturer should hide its head in the sand instead of diligently seeking out - and disclosing - the potential health risks of its products.

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