Zofran for Morning Sickness
Zofran is only approved by the FDA to relieve nausea and vomiting in chemotherapy and surgery patients. However, one of its chief uses has been for severe morning sickness in pregnant women.
Although the FDA has not approved Zofran for morning sickness, many doctors use it as a last resort when other medications fail to help. Doctors are allowed to write prescriptions for unapproved, or “off-label” uses on their own, but it cannot be suggested or promoted by drug companies.
It is estimated that around 75% of women experience nausea and vomiting during the early weeks of pregnancy. Approximately 1% suffer an extreme version of morning sickness called hyperemesis gravidarum (HG). HG involves uncontrollable vomiting that can cause severe dehydration, weight loss and limited nutrition. This requires hospitalization as it can put both the mother and baby at risk.
As many as 15% of pregnant women in the United States are prescribed medication to treat morning sickness, according to a recent study. Unfortunately, the majority of research suggests Zofran may increase the risks of certain birth defects when taken during the first trimester of pregnancy.
GlaxoSmithKline has been accused of promoting Zofran for use in pregnant women, and even paying doctors to prescribe it, in an attempt to broaden its use and increase profits.
In July 2012, GlaxoSmithKline pled guilty and paid a record settlement of $3 billion to the Department of Justice to settle charges that they illegally promoted drugs including Zofran for off-label uses, and paid doctors to prescribe them.