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Zofran Birth Defect Concerns Have Been Growing for Years


March 23, 2015 — Lawsuits accuse GlaxoSmithKline (GSK) of negligence for failing to warn about the risk of birth defects from Zofran, despite the fact that they knew or should have known about a number of concerning studies.

The first well-controlled studies investigating Zofran and pregnancy were conducted in pregnant animals during the 1980s. These studies indicated that Zofran could pass through the placenta and potentially influence fetal development, because there were intrauterine deaths and malformations.

Zofran has never been studied in pregnant women. It is a “Pregnancy Category B,” meaning it is not approved or recommended for pregnant women. Even so, about 1 million pregnant women are prescribed Zofran every year.

In 2006, researchers in Hong Kong confirmed that significant amounts of Zofran could pass through the human placenta when it was taken during pregnancy.

Since then, several studies have found that Zofran increases the risk of birth defects. One study, published by Birth Defects Research in November 2011, linked Zofran and a 2.4-fold increased risk of cleft palate.

Zofran has also been linked to a 30% increased risk of birth defects overall in a study involving nearly 900,000 pregnancies. Other studies have found that Zofran doubles the risk of heart defects, especially “hole in the heart” defects.

GSK is now accused of putting corporate profits above public safety. In 2012, the drug-maker paid a $3 billion settlement to the Justice Department for improperly marketing several drugs, including Zofran “off-label” in pregnant women.

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