Zofran

  • Zofran Medical Record Review & Outsourcing Services

Zofran (Ondansetron) manufactured and originally marketed by GlaxoSmithKline is an antiemetic drug used for nausea and vomiting caused by cancer chemotherapy, radiation therapy, surgery, and gastroenteritis. US FDA approved Zofran in January 1991.

While Zofran was never tested or approved for use by pregnant women, it is often prescribed off-label for morning sickness and hyperemesis gravidarum, a serious type of morning sickness that causes severe nausea and weight loss.

In the past few years, however, disturbing results from a number of studies surfaced linking Zofran to congenital birth defects. Mothers and families of babies born with serious mental and physical deformities are now pursuing lawsuits against the medication's maker, claiming they were misled and lied to about the drug's risks and safety.

Zofran is labeled as Pregnancy Risk Category B, meaning there is no evidence of risk to humans. Many mothers took this assurance to mean the drug was safe, but multiple studies show evidence to the contrary. Because Glaxo never proved the drug was safe, the FDA never gave an approval to market the drug to pregnant women. Regardless, Glaxo continued to advertise its anti-emetic for morning sickness.

Serious Alleged Injuries may include:

  • Musculoskeletal anomalies
  • Mouth deformity
  • Heart defects
  • Jaundice
  • Kidney malformations
  • Cleft lip, Cleft palate, Club foot, webbed toes
  • Fetal growth restriction
  • Fetal Death

FDA Safety Warnings:

  • In September 2011, the FDA announced it made changes to Zofran’s label and required the manufacturer of Zofran to conduct “a thorough QT study to assess the potential for the drug to prolong the QT interval.”
  • In 2012, the 32 mg intravenous dose of Zofran was pulled from the market due to concerns that it could trigger QT interval prolongation, a heart rhythm disorder that could lead to an abnormal and potentially fatal heart rhythm called Torsades de Pointes.

Legal Updates:

In 2012, GSK pled guilty to criminal charges filed by the U.S. Justice Department over the company’s illegal promotion of Zofran and other medications. Around the same time, GSK also entered civil settlements with the U.S. government that included over $1 billion in payments for its illegal marketing of numerous drugs, including Zofran.

In October 2015, lawsuits filed against GlaxoSmithKline (GSK) alleging that the anti-nausea medication Zofran caused birth defects were consolidated into a multidistrict litigation (MDL) in the District of Massachusetts before Judge Dennis F. Saylor, IV, forming MDL 2657 (In Re: Zofran (Ondansetron) Products Liability Litigation).

Nearly 300 lawsuits are a part of the Zofran MDL.

Evidence:

  • Usage of Zofran in pregnant females from Pharmacy Records.
  • Duration of Zofran in pregnant females from Pharmacy Records.
  • Diagnosis of birth related defects in child from Medical Records.
  • Treatment required for birth related defects in child.

Medical Record Review and claim validation of Zofran case should take approximately 5 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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