A new Swedish study has verified that antidepressants known as selective serotonin reuptake inhibitors (SSRIs) increase the risk for birth defects when taken by the mother during early pregnancy.

SSRIs and a Combination Drug Containing an SSRI include:

  • Celexa (citalopram)
  • Fluvoxamine
  • Lexapro (escitalopram)
  • Paxil (paroxetine)
  • Prozac (fluoxetine)
  • Symbyax (olanzapine/fluoxetine)
  • Zoloft (sertraline)

A possible link between SSRIs and birth defects first came to light in late 2005, when the Food and Drug Administration issued a warning that data suggested a possible link between the antidepressant Paxil and birth defects, in particular heart defects. Paxil was downgraded from a Category C drug to a Category D.

Category A and B drugs are generally considered to be safe to use during pregnancy. Category C drugs should only be taken if the potential benefit outweighs the potential risk to the developing fetus. Category D drugs are those that pose a significant risk to a growing fetus and should only be taken when there is risk to the mother if she does not take the drug.

Besides Paxil, no other SSRI antidepressants are currently classified as a Category D. Zoloft, Lexapro, Celexa, Prozac and others are still listed as a Category C.

In 2007, Zoloft was the most prescribed antidepressant on the U.S. retail market with more than 29 million prescriptions. It is primarily used to treat major depression in adults as well as obsessive-compulsive, panic, and social anxiety disorders in adults and children.

That same year, studies began to surface indicating that the use of Zoloft by the mother during the first trimester of pregnancy increased the risk of certain birth defects. A study published in the New England Journal of Medicine found Zoloft likely contributed to birth defects such as omphalocele (an abdominal wall defect in which the infant’s intestines or organs remain outside of the naval), anal atresia (a defect where the opening of the anus is missing or blocked), limb reduction defects, and septal defects (a defect in the ventricular septum, the wall dividing the left and right ventricles of the heart).

But the new study puts the classification of all SSRIs into question. Conducted by researchers from the Department of Forensic Genetics and Forensic Toxicology, National Board of Forensic Medicine in Sweden; and Tornblad Institute at the University of Lund, Sweden, it used data from the Swedish Medical Birth Register from July 1, 1995 to 2007, and involved a total of 14,821 women with 15,017 infants. It measured maternal characteristics, maternal delivery diagnoses, infant neonatal diagnoses and the presence of congenital malformations compared with all other women who gave birth.

The results were alarming. Researchers found an association between antidepressant treatment and pre-existing diabetes and chronic hypertension, but also with many pregnancy complications. Rates of induced delivery and caesarean section were increased. The rate of preterm birth was also increased. Neonatal complications were common, and an increased risk for pulmonary hypertension of the newborn was verified.

“Women using antidepressants during pregnancy and their newborns have increased pathology,” the study’s authors concluded. “It is not clear how much of this is due to drug use or underlying pathology.”

For more information, please visit the following pages:

Paxil and Pregnancy
Zoloft and Birth Defects
Antidepressants and Birth Defects

Cambridge Journals
New England Journal of Medicine

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