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Zofran: Is It Safe During Pregnancy?

The nausea-control drug Zofran may cause birth defects

Zofran is an anti-nausea medication that is approved by the Food and Drug Administration (FDA) for the treatment of nausea and vomiting after chemotherapy, radiation, or surgery. It works by blocking a neurotransmitter in the area of the brain that prompts nausea and vomiting. While Zofran has been approved by the FDA since 1991, it has never been approved to control nausea and vomiting for pregnant women.

Yet Zofran Has Been Marketed to Prevent Morning Sickness

It is alleged that GlaxoSmithKline, the maker of Zofran, marketed the drug to pregnant women. While it is legal for doctors to prescribe medications for off-label uses, it is illegal for drug companies to advertise their drugs for uses that have not been approved by the FDA.

And It Has Been Linked to Potential Side Effects

Studies have linked Zofran and its generic equivalents to serious birth defects, including:

  • Heart defects.
  • Cleft palates.
  • Other serious injuries.

Pregnant women allege that they were never warned about these potential side effects.

In December 2016, the Journal of Obstetrics and Gynaecology Canada, published the opinion of experts who had reviewed several studies about the use of Zofran and its equivalents among pregnant women. The experts concluded that these drugs should only be used by pregnant women when other medications and methods to reduce nausea and vomiting have failed.

Lawsuits Have Been Filed

There are currently hundreds of Zofran lawsuits pending in multi-district litigation (MDL). These cases have been filed by parents who allege that their children suffered birth defects because mothers took Zofran during pregnancy without being warned about the potential risks. They further allege that GlaxoSmithKline may have hid evidence about the risk of birth defects and that GlaxoSmithKline illegally marketed Zofran for use during pregnancy.

If your child suffered a birth defect after his or her mother took Zofran during pregnancy then it is important to find out more about your child’s rights. Please call our experienced drug injury lawyers at 1-800-800-5678 or contact us via this website to discuss your potential claim after a specific drug injury. We would be pleased to provide you with a free consultation.

Jason F. Abraham
Managing Partner, Hupy and Abraham

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