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Zoloft not studied solely for birth defects risk


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As if the alleged birth defects risk is not enough, a British medical journal published a case study suggesting that hepatitis may be related to the use of Zoloft (sertraline), a selective serotonin reuptake inhibitor, or SSRI, antidepressant.

Published in the September 2013 edition of the British Medical Journal Case Reports, the study was centered on a symptomatic 26-year-old in her 20th week of pregnancy. Three weeks after her Zoloft dosage was increased to 100 mg daily, problems arose.

The U.S. National Institutes of Health released the study’s abstract, which read, “The biopsy of the liver showed lobular hepatitis, with a mild prominence of eosinophils, suggestive of a drug-induced or toxin-induced aetiology. Extensive biochemical work-up failed to show any other pathology to account for her hepatitis. Liver function tests normalised after cessation of sertraline, indicating a probable association between sertraline use and acute hepatocellular injury in our patient.”

Researchers wrote that the liver-function problem is rare. But, collectively, mothers who have filed Zoloft lawsuits demonstrate that the increased risk of Zoloft birth defects has been not as rare. The U.S. Judicial Panel on Multidistrict Litigation has centralized 419 Zoloft lawsuits before the U.S. District Court for the Eastern District of Pennsylvania.

Plaintiffs in those Zoloft lawsuits claim, according to one of the panel’s 2012 orders, “that Zoloft causes birth defects in children whose mothers ingest the drug while pregnant.”

A Helsinki University Central Hospital study published in 2012 reported the Zoloft-birth defects tie, citing a relationship between the expectant mother’s Zoloft use and increased risks of “omphalocele, anal atresia, limb-reduction defects, cardiac septal defects and anencephaly.”

All the U.S. Food and Drug Administration will say is, “FDA will update the SSRI drug labels to reflect the new data and the conflicting results.”

Many mothers of malformed infants have all the results they need. They have no compunctions about hiring an attorney, ideally one skilled in handling pharmaceutical injury litigation, and filing a Zoloft lawsuit against Pfizer, the antidepressant’s manufacturer.

Birth defects are not the only concerns with Zoloft and with SSRIs in general. In 2006, the U.S. Food and Drug Administration issued a public health advisory in regard to the apparent relationship between a newborn lung ailment and the mother’s use of an SSRI, such as Zoloft, during pregnancy.

Citing a study published that year in The New England Journal of Medicine, the FDA wrote, “This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. … In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant.”

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