Paxil use in Mothers linked to Serious Birth Defects and Sudden Death in Newborns

By Levin Simes
July 15, 2011

Studies have shown that the popular antidepressant, Paxil, has been linked to serious dis-figuring and life altering birth defects in newborns. In several cases, Paxil-related injuries have been deadly.

Paroxetine (also known by its trade name Paxil) is a popularly prescribed antidepressant. Marketing of the drug began in 1992 by the pharmaceutical company SmithKline Beecham, now GlaxoSmithKline. Paxil is used to treat major depression, obsessive-compulsive disorder, panic disorder, social anxiety, and generalized anxiety disorder in adult patients.

In adults, the effectiveness of Paxil for depression is comparable to that of older antidepressants such as Zoloft and Prozac. Paxil shares the common side effects of other antidepressants such as high rates of nausea, somnolence, and sexual side effects. Unlike other popular antidepressants, Paxil is associated with clinically significant weight gain and statistically significant increase in the risk of suicide in adults. Pediatric trials of Paxil for depression did not prove effective and showed an increase in the risk of harmful outcomes, including episodes of self-harm and potentially suicidal behavior.

Discontinuing Paxil is associated with a high risk of discontinuation or withdrawal syndrome. Due to the increased risk of birth defects, pregnant women or women planning to become pregnant are recommended to consult with their physician. Results of new studies for Paxil suggest that the drug increases the risk of birth defects, particularly heart defects, when women take it during the first three months of pregnancy. In September of 2005, the FDA asked GlaxoSmithKline to change the drug’s pregnancy category from C to D, which is a stronger warning. Category D means that studies in pregnant women have demonstrated a risk to the fetus.

While Paxil is often prescribed to mothers who are experiencing depression or anxious or sad feelings, Paxil is particularly dangerous because it is hazardous to the developing fetus, cause withdrawal symptoms in the newborn baby, and induce biochemical and morphological abnormalities in the brain, problems with organ development, and severe heart malformations. Notably, Several severe birth defects were doubled or nearly tripled in frequency when Paxil was taken in the first trimester.

As of 2007, Paxil use by pregnant mothers in the first trimester of pregnancy was
shown to have links to several salient birth defects. First, Anencephaly, birth without a forebrain, showed a 2.4 times greater occurrence in women who had taken Paxil in the first trimester. This is a catastrophic, fatal birth defect that is not correctable. Second, Omphalocele, babies born with organs outside the body, was found to be present 2.8 times as often in the Paxil-treated mothers compared to the control group. Some media portrayed this birth defect as a small hernia of the umbilical cord-but severity of the condition varies, usually requires surgery as well as weeks to years of adapting, and can be life-threatening. Third, Craniosynostosis, the premature closing of one or more or fibrous joints knitting the bones of the infant’s skull, showed 2.5 times more prevalence babies exposed to Paxil. This condition also varies in severity. It can be primarily a bone condition of the skull or it can be secondary to an underdeveloped brain in the infant. Lastly, Paxil has also been linked to causing the defect Persistent Pulmonary Hypertension, obstruction of blood flow to the lungs, which has been associated with shortness of breath, dizziness, and fainting.

In addition to birth defects, Paxil has been shown to cause several withdrawal symptoms when mothers are taken off Paxil including irritability, high-pitched or weak crying, tremors, poor muscle tone, disturbed sleep, rapid breathing and respiratory distress, and increased admissions to the neonatal intensive care unit. Alarmingly, several reports in 2007 dismissed Paxil’s link to birth defects and the prescription of Paxil and other harmful antidepressants rose by 9 percent between 1999 and 2007.


Paxil has been shown to be linked to several serious and, at times, fatal birth defects including lack of development or no development of the forebrain (Anencephaly), appearance of organs outside of the body (Omphalocele), particularly near the umbilical cord, unnatural fusing of joints in the developing brain (Craniosynostosis), which often leads to malformed skull structure and face structure, lack of room for brain growth and resultantly high pressure on the brain, and several other related problems, and problems with blood flow to the lungs (Persistent Pulmonary Hypertension). In addition its birth defects, Paxil has also been linked to several key withdrawal symptoms such as problems with muscle tone, breathing problems, high pitched and weak crying, and other related issues.


Birth Defects:

  • Appearance of organs outside of the body
  • Malformed/unusual skull and face structure
  • Little to no forebrain development
  • Problems with circulation to lungs
  • General Breathing problems
  • Club foot
  • Sudden Death due to brain or lung problems

Withdrawal Symptoms:

  • Unusually high pitch or low pitch crying
  • Poor muscle tone
  • Persistent breathing problems

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