Is Zofran Safe to Use During Pregnancy for HG (Hyperemesis Gravidarum) or Morning Sickness?
GlaxoSmithKline has never established that their anti-nausea drug Zofran is safe for pregnant women. Yet the drug maker generates substantial sales from the “off-label” use of Zofran for treatment of morning sickness or more severe pregnancy nausea, known as hyperemesis gravidarum (or HG pregnancy).
Zofran (ondansetron) is only approved by the FDA for treatment of nausea experienced following chemotherapy, radiotherapy and surgery. However, it is widely assumed that Zofran is safe during pregnancy because GlaxoSmithKline has illegally promoted their drug for years.
In 2012, GlaxoSmithKline agreed to pay $1.5 billion to resolve claims brought by the Justice Department over illegal marketing of several different drugs for uses that were never approved by the FDA, including “off-label” promotion of Zofran for HG pregnancy and morning sickness.
Studies Question Safety of Zofran for Pregnant Women
Increasing evidence suggests that Zofran is not safe during pregnancy, with several studies published in recent years indicating that the medication may increase the risk that children will develop serious and potentially life-threatening birth defects, including:
- Oral Cleft Defects (i.e. Cleft Palate or Cleft Lip)
- Congential Heart Defects (i.e. atrial septal defects, ventrical septal defects, other malformations)
It appears that GlaxoSmithKline placed their desire for profits before the safety of children by promoting Zofran for HG pregnancy or morning sickness without conducting adequate studies to establish that Zofran is safe for unborn children.
Morning sickness is one of the most common problems experienced by pregnant women, with an estimated 75% of women experiencing nausea or vomiting during the first trimester of pregnancy. Therefore, encouraging prescription of Zofran for morning sickness widely expanded the market for this drug.
HG pregnancy nausea is a rare, more severe form of morning sickness that often leads to pregnant women being hospitalized.
Failure to Warn About Zofran HG Pregnancy, Morning Sickness Risks
Women and the medical community have not been provided fair and accurate information about potential pregnancy side effects of Zofran. As a result, children who now suffer permanent and life-long health problems that may be entitled to financial compensation through a Zofran pregnancy lawsuit.
The product liability lawyers at Saiontz & Kirk, P.A. provide free consultations and case evaluations for families throughout the United States. All cases are handled by our Zofran attorneys under a contingency fee agreement, which means that there are no fees or expenses unless a recovery is obtained.