Why do Canadian Zofran labels warn against use during pregnancy?

woman who took Zofran during pregnancy
The plaintiffs involved in MDL 2657 have recently discovered that the label on the drug Zofran in Canada warns against the use of the drug during pregnancy, unlike the U.S. label.

The Canadian Warning

The Canadian package reads, “the safety of ondansetron for use in human pregnancy has not been established,” and “use in pregnancy is not recommended.”

U.S. plaintiffs who have filed a Zofran lawsuit alleging that the drug caused a birth defect in an unborn child are wondering why the drug was given this warning in Canada but not in the States.

The Lawsuits

Over 200 lawsuits have been filed against GlaxoSmithKline (GSK) alleging that the drug caused a birth defect such as a ventricular septal defect, atrial septal defect, transposition of the greater vessels, respiratory distress syndrome, clubfoot, kidney defects, cleft lip, and cleft palate.

Zofran has been available to patients by prescription since 1991. The U.S. Food and Drug Administration gave their approval for the drug that same year, although they reported on the label that the drug was only to be given to patients experiencing vomiting and nausea after undergoing anesthesia, chemotherapy, and radiation. No human trials on expectant mothers demonstrating safety for the mother and child had been performed and so the administration did not approve the drug as a treatment for morning sickness.

MDL 2657

In October of 2015, the Judicial Panel on Multidistrict Litigation consolidated federally filed Zofran lawsuits into MDL 2657. They determined that the consolidation was appropriate because each lawsuit contains similar “questions of fact”. These questions include:

  • Was a birth defect in an unborn child caused by Zofran?
  • Did GSK unlawfully promote the drug “off-label”?
  • Did GSK fail to release evidence that the drug caused birth defects?

These complaints will be tried in the U.S. District Court for the District of Massachusetts under the Honorable Judge F. Dennis Saylor. The purpose of consolidation is to prevent duplicate discovery, prevent conflicting rulings, and save time and money for all parties involved.

When Will Trials Begin?

Before any trials can take place, both parties must go through the discovery phase. The discovery phase has not yet begun, although it is expected to begin soon. Judge Saylor has appointed the co-lead counsel and will soon appoint the Plaintiff’s Steering Committee. After that, it is likely the litigation process will gain momentum.

About Laurence Banville

Attorney Contributor:

Laurence P. Banville, Esq. is the managing partner of Banville Law. He is a regular contributor on several topics including negligent security cases, child sexual abuse and Dram Shop and liquor liability cases.

This article was fact checked prior to publishing by this author to ensure compliance with our rigorous editorial standards. We will only use authoritative sources. Our values compel us to provide only trustworthy information. If you find an error, please contact us.

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