Information about Zofran.

Zofran manufacturer faces more than 30 birth defects lawsuits

September 5th, 2015

British pharmaceutical giant GlaxoSmithKline faces more than 30 Zofran lawsuits alleging that the drug caused severe birth defects in children born to women who were given Zofran during pregnancy. The anti-nausea drug was approved in 1991 by the U.S. Food and Drug Administration for use in surgery and cancer patients, but has increasingly been given to pregnant women to combat morning sickness.

GlaxoSmithKline has faced legal trouble for illegally marketing its drugs for unapproved uses before. In 2005, GSK paid $150 million to the Justice Department to settle allegations of fraud relating to the pricing and marketing of Zofran. The company also paid $3 billion in 2012 to settle a lawsuit alleging it illegally promoted drugs, including Zofran, for unapproved uses.

Several studies have found that Zofran could lead to an increased risk of several birth defects in children who were exposed to the drug in utero. Zofran birth defects include cleft palate defects, heart defects, brain defects and other congenital birth defects.


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