August 10, 2015 — A lawsuit has been filed on behalf of a boy who was born with only one kidney after his mother used Zofran, an anti-nausea drug, during her first trimester of pregnancy.

In 2007, Angela and Bryan Kutzer gave birth to “G.K.” However, it was not until October 2013 that he was diagnosed with a missing kidney — a kidney defect known as congenital unilateral renal agenesis.

The birth defect was discovered when he suffered a kidney injury at home. After he was hospitalized, doctors discovered he had one kidney with only 38% of its normal function. Doctors told the boy he cannot play sports. As an adult, he will have extreme difficulty producing children and may have sexual dysfunction.

The lawsuit blames GlaxoSmithKline (GSK) for marketing Zofran “off-label” to pregnant women without ever conducting safety studies or warning about birth defects. According to the lawsuit (PDF):

“Had plaintiffs known the truth about Zofran’s unreasonable risk of harm, long concealed by GSK, plaintiff Angela Kutzer would have never taken Zofran, and her child G.K. would never have been injured.”

This is not the first time Zofran has been linked to kidney defects. In 2013, a study found a 20% increased risk of birth defects, including an increased risk of kidney defects. Another investigation published in the Toronto Star last year linked Zofran with kidney malformations and other serious birth defects.


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