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Have you taken Zofran?

  • November 26, 2015

Zofran users, WILL DAVIDSON LLP, one of the largest personal injury law firms in Southern Ontario is currently investigating lawsuits on behalf of individuals who have been harmed after taking the drug Zofran while pregnant. This drug was initially prescribed to assist cancer patients undergoing Chemotherapy and radiotherapy as well as patients undergoing care of surgical anesthesia. Most recently pregnant women suffering from severe morning sickness have received prescriptions from their doctors and have reportedly given birth to babies with birth defects.

zofran blog entry

What is Zofran

Zofran is a drug manufactured by GlaxoSmithKline in 1996 and was originally prescribed for the prevention of severe nausea and vomiting for patients suffering in the following two categories:

  • Patients receiving treatment for chemotherapy or radiotherapy for the treatment of cancer
  • Patients under the care of surgical anesthesia





Health Canada approved the above mentioned use of Zofran, as well as generic equivalents with the same active ingredient (ondansetron), for these two areas of treatment.For the past 30 years, Canadian doctors have provided patients with Diclectin  to prevent nausea and vomiting. However, more recently, Canadian doctors are prescribing ondansetron to treat women with early pregnancy symptoms of severe morning sickness.

Is there a link between Zofran & Severe Birth Defects

Researchers at Harvard University reviewed birth records of 10,000+ pregnant women and found women who had taken Zofran had an increased risk of birth defects. In comparing women who were exposed to ondensatron during the first trimester of pregnancy to those who were not, they found women who took the drug were 2.37 times more likely to have babies with cleft palates than the women who did not take the drug.


Australian study reveals increase in rare kidney defects

In Australia, researchers compiled data from birth records filed between 2002-2005 which equated to more than 95,000 births. Researchers then identified the number of women who were prescribed Zofran  in the first trimester of pregnancy were 20% more likely to deliver babies with major birth effects. In addition women who delivered babies after taking Zofran were reported to be six times more likely to develop rare kidney defects.


In Canada 

An article published in the Toronto Star last August reported 20 Canadian women who were prescribed ondansetron and as a result experienced alleged side-effects, including two infant deaths and multiple cases of newborns with heart defects and kidney malformations.

Renowned pediatrician and founder of the Hospital for Sick Children’s Motherrisk program in Toronto, Gideon Koren was quoted as saying “Here is a drug not meant for pregnancy, given in pregnancy, with no data.”

Koren was one of the first doctors to investigate Zofran’s effects on pregnant women. His initial study revealed no correlation between malformations and ondasetron; however, since 2004 he has revised his position. Reporting, serious side-effects among women and babies exposed to ondansetron.


How Has Health Canada Responded

Health Canada has not mentioned the potential birth defects but instead has acknowledged in the labelling of the drug that “the safety of ondasetron for use by pregnant women has not been established. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.”

To date Health Canada has responded to the warning on the label by saying  “ currently, no emerging safety issues requiring further assessment related to ondasetron use in pregnant women have been identified.”


Personal Injury Lawyers Toronto

The personal injury lawyers at Will Davidson LLP have a proud history of acting as counsel for individuals in product liability cases. Our lawyers are passionate about what they do and understand that taking prescribed medication when gone wrong can be life changing.

Will Davidson LLP has a proven track record of successfully representing individuals who are victims of pharmaceutical drugs and suffering when not properly informed of the side effects these drugs can cause. Our personal injury lawyers are highly specialized in handling claims from individuals like you.

If you or a loved one has been affected by Zofran, please contact our office to discuss your situation and how you may be entitled to compensation for your injuries. Our personal injury lawyers have been representing clients for over two decades and can provide you with results you can trust. Our lawyers are recognized by peers in the legal industry for their outstanding work helping clients obtain the settlements they deserve in product liability cases.

The personal injury lawyers at Will Davidson LLP provide legal services to clients at our locations in Oakville, Huntsville, Lindsay, Markham, Midland, Orillia, Toronto, BurlingtonWhitby and Bowmanville. For a free consultation, contact us today to speak to one of our lawyers.



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