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Michael Monheit
Michael Monheit
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New Birth Defect Analysis Cited In Zofran Lawsuits


As of today, 224 Zofran birth defect lawsuits have been consolidated in the US District Court for Massachusetts, under the expert guidance of Judge F. Dennis Saylor IV. In each filed complaint, a family accuses GlaxoSmithKline of fraudulently promoting its anti-nausea drug for unapproved use during pregnancy – and concealing evidence that Zofran can increase the risk for major birth defects.

Most of the lawsuits have been filed in relation to congenital heart defects, and citing a series of studies conducted between 2013 and 2014. Parents note that, after taking the drug in the first trimester, mothers included in these studies were between 200% and 400% more likely to deliver babies with 3 specific heart defects: atrial septal defect, ventricular septal defect and atrioventricular septal defect.

New National Birth Defect Data Supports Zofran Concerns

Families have also relied on an earlier study, conducted in 2012, that found among data gathered by the National Birth Defects Prevention Study (a government-funded program of the US Centers for Disease Control & Prevention) a link between Zofran and cleft palate. But in the three years since that study was published, the National Birth Defects Prevention Study has continued collecting new information, and researchers have continued to study it. That research, however, hasn’t made it’s way into any new Zofran lawsuits – until now.

On January 2, 2016, a mother from Virginia says she was prescribed Zofran during early pregnancy, and then delivered a child with Tetralogy of Fallot, a rare cluster of four congenital heart defects.

To substantiate her allegations, the mother cites four major studies, only three of which should be familiar to readers who have followed this litigation. The fourth study was just completed, and its final results have not yet been published. But its initial findings were presented at a recent conference of the International Society of Pharmacoepidemiology, which brought researchers from across the world to Boston in August of 2015.

Kidney, Diaphragm & Heart Condition Identified As New Potential Risks

The paper, titled “Ondansetron for the Treatment of Nausea and Vomiting of Pregnancy and the Risk of Birth Defects,” re-analyzed data from the National Birth Defects Prevention Study (NBDPS) to investigate the potential association between ondansetron, Zofran’s active ingredient, and major birth defects.

According to its authors, the analysis found a “modestly elevated” risk for cleft palate, which was around 50% more likely in babies exposed to Zofran before birth, in the data from NBDPS. But reviewing a separate data set, maintained by Boston University, they found an opposite result: the rate of cleft palate seemed lower in babies exposed to Zofran.

Hypoplastic left heart syndrome, in which the heart’s left side fails to develop completely, was also elevated, with another 50% risk increase.

A link to kidney defects was also observed. The risk of renal atresia, in which babies are born missing one or both kidneys, jumped 230% in children exposed to Zofran. Diaphragmatic hernia rounded out the group of previously-unobserved associations, at an increased risk of 70%. Children with the condition are born with holes in their diaphragm, the layer of muscle separating the chest from the abdomen.

The new study’s abstract is available here. The Virginia mother’s lawsuit was filed directly in the US District Court of Massachusetts under the case number 1:16-cv-10153-FDS. A copy of the complaint has been made public on ZofranLegal.com.

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