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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

1997 – Paxil Causes Neonatal Abstinence Syndrome

Posted in Paxil Birth Defects, SSRI Birth Defects

Published in a 1997 edition of The British Journal of Psychiatry by the medical researchers M.L. Dahl et al., a letter to the editor titled “Paroxetine withdrawal syndrome in a neonate” aimed to describe and characterize neonatal withdrawal from Paxil® addiction through exposure to the drug during gestation.

This letter describes a case report, a description of a single case of Paxil® withdrawal symptoms in a newborn.  The mother of this child used Paxil® daily during the third trimester of pregnancy, and thankfully, the child was born at a normal weight and was delivered at a full term.[1]

However, after 12 hours of life, the child was “transferred to the neonatal department for observation because of increased respiratory rate (80 per minute) and jitteriness.  During the next hours he developed increased muscle tone and tremor.”[2]

A number of tests performed on the newborn, however, did not reveal any abnormalities: “C-reactive protein, hemoglobin  blood gases, blood glucose, electrolytes, ionized calcium and ultrasound of the brain were all normal.”[3] (emphasis added)  Doctors concluded that these symptoms were caused by exposure to Paxil® used by the mother during pregnancy.

Fortunately, after four days, the child was discharged with generally good health, though still suffering from prolonged jitteriness.[4]

Due to the fact that this report was published so early, the author writes that “As very little information is available for the newer antidepressants, including SSRIs, they are not recommended during pregnancy.”[5] (emphasis added)

Because the warning label for Paxil® was not changed to include anything about risk for adverse neonatal outcomes until 2005 when the FDA required the manufacturer to do so, a number of Paxil birth defect lawsuits are currently being filed.

If you or a loved one used Paxil® during pregnancy and your child was born with neonatal abstinence syndrome, please do not hesitate to contact our team of Paxil® birth defect lawyers at the information provided below.  We have the experience, resources, and skills needed to fight even the largest pharmaceutical companies and win the justice your family deserves.

At your convenience, you may reach our team by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us for a free, no-obligation case consultation.

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


[1] Dahl, M.L. (1997) “Paroxetine withdrawal syndrome in a neonate” British Journal of Psychiatry Correspondence. Vol. 171; pp. 391-392

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.