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Zofran Birth Defects

What is Zofran?

Zofran (Ondansetron) is an anti-nausea drug prescribed during chemotherapy/radiation treatment or after surgery to avoid vomiting.

However, it has also been prescribed to pregnant women to manage morning sickness – a use which the FDA has never approved. Now, several studies are linking Zofran to serious birth defects. Those harmed by Zofran are now seeking compensation in courts.

In 2009, Zofran was the most prescribed morning sickness medication in the United States.

What birth defects have been linked to Zofran?

Institutions like the Center for Disease Control (CDC) and the Center for National Birth Defects have linked Zofran to:

  • Cleft palate

  • Cleft lip

  • Spinal Bifida

  • Structural heart defects

  • Cranial defects

When taken with SSRI antidepressants – such as Prozac – Zofran has also been linked to serotonin syndrome. The symptoms include confusion, agitation, headache, changes in behavior, heavy sweating, seizures, irregular heartbeat, or unconsciousness.

GlaxoSmithKline Civil Suit

The GlaxoSmithKline lawsuit (GSK) alleges that GSK marketed Zofran as a way of treating morning sickness during pregnancy. The FDA never approved the drug and even sent a letter in 1999 telling GSK to stop marketing the drug for off-label use. But GSK ignored this and as well as its own studies on the possible effects of Zofran on pregnant women.  There are even claims GSK did not conduct these because it was in a rush to release the drug faster in order to drum up profits. The GSK lawsuit claims GSK acted unethically and with negligence by not conducting further research and ignoring studies that would hurt their bottom line.

The allegations against GSK include:—————————————

  • Failing to determine safety risks before selling and marketing Zofran to the public.

  • Failing to warn the public about the known dangerous side effects of Zofran.

  • Advertising Zofran as a safe morning sickness medication when it  was not approved for such use.

  • Misrepresenting animal studies that portrayed Zofran as safe, when in reality trials showed abnormal bone growths and toxicity as a result of Zofran.

  • Failing to evaluate data and safety information pertaining to Zofran’s use in pregnant women.

  • Producing a defective drug.

  • Fraudulently claiming Zofran was safe to use for pregnant women.

In 2012, they pleaded guilty to criminal charges for promoting Zofran’s off-label use and paid out $3 billion in damages, leading to the first GSK suit.

GSK’s birth defect lawsuit includes:

  • Cleft palate lawsuit

  • Cleft lip lawsuit

  • Heart defect lawsuit

  • Spinal Bifida lawsuit

  • Zofran Lawsuit Attorney

If you or someone you know has been prescribed Zofran while pregnant and suffered any side effects or given birth to a child with birth defects and are looking for a Zofran attorney, contact the law offices of Viñas & DeLuca. We have experience in handling personal injury claims specializing in dangerous drugs. Viñas & DeLuca are committed to taking on unethical corporations and recovering damages for our clients from birth injuries/medical negligence and product liability. Contact us today for a free case evaluation.