Zofran® Birth Injury Risks

What is Zofran®?

zofran

Zofran® is a prescription drug used to prevent nausea and vomiting in cancer and post-surgery patients. The drug was developed and is manufactured by GlaxoSmithKline (GSK). The U.S. Food & Drug Administration (FDA) approved it for use in 1991, but limited that approval to treating nausea and vomiting after surgery and nausea and vomiting related to chemotherapy or radiation treatments.

Zofran® became a top selling drug in the United States, securing $1.3 billion in sales in the first nine months of 2006. Later that year, the drug's patent protection expired and the FDA granted approval for a generic version, Ondansetron.

Doctors routinely prescribed Zofran to treat morning sickness in pregnant women during their first trimester. This was NOT a use approved by the FDA. Recent studies suggest taking Zofran during pregnancy may impact the health of the unborn child and may lead to serious birth injury risks.

Zofran® Birth Injury Risks

  • Birth defects
  • Heart defects
  • Heart murmur
  • Atrial or ventricular septal defect ("hole in the heart")
  • Cleft lip
  • Cleft palate
  • Fetal growth restriction (poor growth in the womb)
  • Jaundice
  • Kidney defects
  • Life-threatening pregnancy complications
  • Death

What did the Manufacturer Know?

In July 2012, GSK paid $3 Billion for Illegal marketing of Zofran® and other medications. The U.S. Department of Justice announced that Zofran admitted to multiple violations, including promoting Zofran® for pregnant women with morning sickness and paying kickbacks to doctors who prescribed the drugs. Federal law prohibits pharmaceutical companies form marketing drugs "off-label" for uses that are not approved by the FDA.

Studies Link Zofran® to Birth Injuries

Zofran® has NEVER been approved to treat morning sickness in pregnant women. In fact, little is known about the safety of Zofran's use during pregnancy. The studies to date suggest that taking Zofran, especially during the 1st trimester, increases the risk of birth defects. Research includes:

  • A 2013 Danish study reviewed a national registry of 900,000 birth records from 1997 to 2010 and found a 30% increased risk of birth defects and a two-fold increase in risk of heart defects in the child attributed to the mother taking Zofran®.
  • In 2012, the FDA issued a Safety Communication to warn that the 32-mg dose of Zofran® will no longer be marketed due to the risk of deadly cardiovascular side effects.
  • In 2011, the FDA issued a Safety Communication that patients taking Zofran® have an increased risk of suffering a potentially fatal arrhythmia Torsade de points. During pregnancy this could be fatal for both the mother and child.
  • In 2014, the Toronto Star, a Canadian newspaper, conducted a Zofran investigation and reviewed 2012 records from the FDA's public side-effect report database. Reporters discovered that at least 20 Canadian women treated with Zofran® during pregnancy reported newborns with serious birth injuries including heart defects and kidney malformations. Two infant deaths were also reported.
If you or a loved one took Zofran® while pregnant and had a baby with a birth defect such as those listed above, you may have a legal claim. George & Farinas, LLP lawyers are currently investigating the legal rights of parents whose children were harmed by the prescription drug Zofran® or its generic counterpart, Ondansetron. Call today for a FREE, No Hassle consultation at 1-888-277-0500.

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