Parents of a newborn baby who died of anencephaly claim that the anti-depressant, Zoloft, cause their baby’s fatal birth defect. Susan and James Hodge’s baby died 18 hours after his birth, said Courthouse News.
Anencephaly is a devastating diagnosis that can be caused by an array of factors; however, research has linked this distressing disorder to a number of medications, including the selective serotonin reuptake inhibitor (SSRI), Zoloft, when taking just prior to or during pregnancy. Anencephaly results in the absence of the skull or brain, including the cerebral hemispheres and cerebellum, as well as facial feature abnormalities, and heart defects. Anencephaly is a traumatic neural tube defect that occurs early in fetal development and involves failure of the neural tube to close.
The Hodge’s allege that it was Zoloft—manufactured by drug giant, Pfizer—that caused their son to be born without a large part of his brain. The Hodge’s also allege that Pfizer covered up studies pointing to this horrendous side effect, said Courthouse News. The couple have sued Pfizer and Cardinal Health in the Cuyahoga Court of Common Pleas.
“Prior to the time that the mother plaintiff ingested Zoloft during her pregnancy, Pfizer knew of the dangerous birth defects associated with Zoloft’s use during pregnancy from the preclinical studies and the subsequent published studies confirming these risks. Pfizer took no action to adequately warn or remedy the risks, but instead, concealed, suppressed and failed to disclose the dangers,” the complaint stated, wrote Courthouse News. The complaint also alleges that prior to Susan’s becoming pregnant, Pfizer and the drug’s distributor “knew or should have known that taking Zoloft during pregnancy posed risks to the developing fetus. Pfizer knew or should have known that Zoloft crosses the placenta, which could have important implications for the developing fetus,” Courthouse News reported.
Antidepressants have long beeen linked to birth deects. As a matter-of-fact, a 2007 study published in the Harvard School of Public Health revealed that a mother’s use of an SSRI was linked to three neural tube defects, including anencephaly..
“The mother plaintiff read the drug information and instructions that accompanied the Zoloft prescription prior to her taking Zoloft. The mother plaintiff trusted that serious conditions associated with Zoloft, such as congenital birth defects, would have been included in the written drug information … [and] relied upon the fact that congenital birth defects … were not listed or emphasized on the Zoloft monograph and/or drug information as a basis to believe that Zoloft was safe for use during her pregnancy,” the complaint went on to state.
According to the Hodges, Pfizer was fully aware of Zoloft’s risks but did not amend the drug’s warning labeling, although that is mandated under U.S. Food and Drug Administration (FDA) regulations, Courthouse News pointed out. “During the entire time Zoloft has been on the market in the United States, FDA regulations have required Pfizer to issue stronger warnings whenever there existed reasonable evidence of an association between a serious risk and Zoloft,” states the complaint.