Zofran and Hypospadias: Possible Link Indicated in 2004 Medical Journal

By Rheingold Giuffra Ruffo & Plotkin LLP

As we have written about previously, the Zofran litigation against GlaxoSmithKline is rapidly developing. The drug maker marketed Zofran, an anti-nausea medication, for use during pregnancy without having tested its possible effect on fetal development.

The 2004 article “The safety of ondansetron for nausea and vomiting of pregnancy: a prospective comparative study,” appeared in the BJOG, an International Journal of Obstetrics and gynecology. In their article, the authors acknowledged hypospadias as a major malformation (defined as one which requires surgical intervention) which might be associated with Zofran use. Hypospadias, is a condition where the opening of the urethra is on the underside of the penis, instead of the tip.

However, because of the relatively small size of their sample group, the authors could not draw a definitive conclusion. The authors did note that additional studies are “required to achieve significant power to address any potential association between Zofran and hypospadias.” Unfortunately, no further research has been done by GlaxoSmithKline to study the connection this birth defect and Zofran use in pregnant women.

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