Drugmaker GlaxoSmithKline knew Zofran pregnancy risks, yet marketed the drug to pregnant women anyway. GSK began to market Zofran to Americans in 1991. The company promoted Zofran “off-label,” for purposes which the FDA had not approved. By law, it was allowed to market Zofran only to doctors treating cancer patients and those suffering from post-surgery nausea. But GSK nevertheless promoted Zofran for use as an anti-nausea drug during pregnancy.
GlaxoSmithKline vs. U.S. Government
The U.S. government brought allegations against GSK that involved Zofran and several other drugs. All became part of a huge settlement. After pleading guilty, GSK paid more than $3 billion in criminal and civil fines. The company agreed to pay the penalty for giving doctors kickbacks. The company had enticed doctors to use and promote Zofran off label.
GSK knew Zofran Pregnancy Risks
After GSK tested Zofran on bunnies and rats back in the early 1980s, it used those dubious studies to claim there was no link between Zofran and birth defects. The company admitted to performing few rat studies in the past which did not translate to similar risks in humans. Records also show that GSK acquired knowledge of two cases of birth defects in 1991 after a mother-to-be took Zofran for severe morning sickness during her first trimester.
Drugmaker knew Zofran Pregnancy Risks
GSK steadily received reports of birth defects – 32 by the year 2000, more than 200 by 2014. The company nonetheless failed to issue warnings or amend Zofran labels to reflect pregnancy risks. Zofran ad campaigns instead became bolder. Catchy promotional phrases appeared where warnings should have been to push the budding blockbuster: “Zofran Can” and “24 hour control” became the drug’s watchwords. Meanwhile, GSK was also aware of several epidemiological studies which linked Zofran with various birth defects.
FDA Launches Zofran Investigation
The FDA became aware of the off-label marketing of Zofran back in 1999 and issued a communication which stated the drug’s advertising was “false and misleading.” FDA ordered that GSK, “[I]mmediately cease distribution of this and other similar promotional materials for Zofran that contain the same or similar claims without balancing risk information.” Further, while the drug was never approved for use for nausea in pregnant women, GSK promoted Zofran in its prescription instructions by labeling.