Zofran (ondansetron) is an antinausea drug. It is intended for significant nausea issues caused by things like chemotherapy. However, Glaxo SmithKline also marketed it for use with pregnant women. The problem was that Glaxo SmithKline had failed to do any testing of the drug with pregnant women. In 2006, prior to its becoming available in a generic form, Zofran was among the top selling drugs in the United States. The FDA estimated that number nearly a quarter of Zofran prescriptions were given to pregnant women.
As early as 2006, in a study published in Hong Kong, concerns were raised about the use with pregnant women. The Hong Kong study concluded that Zofran cross the placenta to the fetus. More studies were done. In 2011 a British study concluded that women who took Zofran were over twice as likely to have babies with congenital defects, including cleft palates. In August 2013 a Danish study found that children were to four times more likely to have babies born with congenital heart defects. It is clear that additional studies are needed.
Glaxo Smith Kline engaged in illegal conduct in its off label marketing of Zofran. Giving Zofran to pregnant women is considered off label use. In July 2012 Glaxo Smith Kline entered into a settlement agreement with the United States Department of Justice to resolve claims that it illegally marketed Zofran, among other drugs. It agreed to pay a fine of $1 billion, which included a criminal fine and a forfeiture. It also agreed to pay another 2 billion to resolve claims by the government under the False Claims Act. The settlement resolves criminal issues, alleged by the federal government, that Glaxo Smith Kline had paid kickbacks to healthcare providers to get them to prescribe drugs.