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Zofran (ondansetron) Birth Defect Lawsuits In Canada Ontario and Quebec

Investigation



Zofran (ondansetron) Birth Defect Lawsuits In Canada Ontario and Quebec:

CONSUMER LAW GROUP is investigating the launch of a Canada-wide class action lawsuit out of Ontario and Quebec against the maker of Zofran (ondansetron) GlaxoSmithKline Inc. on behalf of women who took the drug during pregnancy and whose children were later born with birth defects.

Birth defects mentioned in the lawsuit include:

• Heart defects, including septal defects (holes in the heart)
• Heart murmur
• Atrial septal defect
• Cleft lip
• Cleft palate
• Musculoskeletal Defects
• Club foot
• Kidney defects
• Hydronephrosis
• Hypospadia
• Craniosynostosis (skull deformities)
• Fetal growth restriction (poor growth in the womb)

Zofran (ondansetron) was approved by the FDA and Health Canada to help cancer patients with nausea after treatments or after surgery. But drugmaker GlaxoSmithKline soon found other patients to take the drug – pregnant women suffering from morning sickness. The FDA and Health Canada never approved Zofran for use by pregnant women. In 2012, GlaxoSmithKline pleaded guilty to federal charges of fraud and illegal promotion of several drugs, including Zofran, and paid $3 billion as part of a settlement.

Zofran, an anti-nausea drug that is used “off-label” for morning sickness in pregnancy, has been linked to hundreds of reports of birth defects. Studies have also found a 30% increased risk of birth defects, a doubled risk of certain heart defects, and even higher rates of cleft palate.

In August 2013, researchers published a study linking Zofran with a doubled risk of heart defects, leading to a 30% increased risk of birth defects overall. Of the 1,248 women who used Zofran during the first trimester, 4.7% had a baby with a birth defect, compared to 3.5% of women who did not use Zofran.

In December 2013, Australian researchers found a non-significant 20% increased risk of birth defects associated with Zofran.

In December 2014, Reproductive Toxicology published a study by researchers in Sweden who found that Zofran doubled the risk of septal heart defects (also known as “hole in the heart” defects).

Zofran was linked to a 2.4-fold increased risk of cleft palate in a study published by Birth Defects Research in 2012.

Australian researchers found a possible sign of kidney defects when Zofran was linked to a 6-fold increased risk of malformations described as “obstructive defects of renal pelvis and ureter.” Obstructive defects often result in hydronephrosis, which can cause kidney failure.

The class action lawsuit identifies the group of affected persons as:

All women residing in Canada who were pregnant at the time that they were prescribed the drug ondansetron (sold under the brand name ZOFRAN) and took and/or purchased, as well as, their children born after their mother ingested the medication or any other group to be determined by the Court.

If you or a member of your family have used the drug Zofran (ondansetron) and whose child was born with an abnormality and you wish more information on potential compensation or to be kept advised of the status of the Zofran (ondansetron) Birth Defect Class Action litigation or any resulting compensation from the Zofran (ondansetron) Birth Defect Lawsuit in Canada, Quebec or Ontario, please provide your contact information to our law firm using the below form.

IF YOU WISH TO JOIN THE CLASS ACTION OR TO SIMPLY GET MORE INFORMATION, PLEASE COMPLETE THE FORM BELOW. Please note that providing your information creates no financial obligation for you. You are not charged any fee or cost for joining this class action. Our law firm is paid a contingency fee from the compensation recovered, only if the class action is successful. All information contained in this transmission is confidential and Consumer Law Group agrees to protect this information against unauthorized use, publication or disclosure.


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