Zofran Recall

Recent studies show that Zofran (ondansetron) may be the cause of serious birth defects around the country. Zofran is FDA-approved to treat nausea suffered during chemotherapy, but it has been widely prescribed for off-label use as a nausea medication for pregnant women. Unfortunately, there is mounting evidence this off-label use may cause a range of serious birth defects in newborn children.

Zofran Linked to Serious Malformations

In 1999, the maker of Zofran, GlaxoSmithKline, was warned by the FDA about their marketing practices making strong claims about the effectiveness of the drug while limiting the warnings about adverse side effects. In 2012, a recall of certain dosages that had been linked to increased risk of fatal heartbeat irregularities led to a $3 billion payout; however, Zofran was still being prescribed in both chemotherapy and pregnancy cases.

Risks of use during pregnancy were not studied before the drug came to the market and this lack of testing has led to children being born with the following:

  • Cleft Lip or Cleft Palate
  • Club Feet
  • Kidney Malformations
  • Skull Malformations
  • Congenital Heart Defects
  • Death

If GlaxoSmithKline had properly researched the pregnancy risks associated with the medication and warned about off-label use of Zofran for morning sickness, many of these severe health problems could have been avoided.

If you think your child has suffered from drug injury birth defects as a result of Zofran, contact the defective product attorneys of GoldenbergLaw today to schedule a free consultation.


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