What Comes Under Zofran Birth Injury Lawsuit

A recent study casts doubt on the safety of Zofran, a popular morning sickness and nausea drug sometimes prescribed to pregnant women – and findings suggest the drug increases the risk of severe birth defects and injury to the mother.

Zofran is a 5-HT3 receptor antagonist manufactured by GlaxoSmithKline and is also available in its generic form, ondansetron. It works by affecting serotonin levels in the brain and was originally approved in 1991 to treat nausea and vomiting in cancer patients or after surgery. But, doctors continue to prescribe it “off-label” to treat nausea and vomiting during pregnancy (NVP).

Doctors also prescribe Zuplenz, a similar drug, to mothers suffering from morning sickness. With the equivalent chemical make up as Zofran, this drug can engender pregnancy.

A study by Dr. Gideon Koren published in the December 2014 issue of American Journal of Obstetrics and Gynecology highlights the risks of pregnant women taking Zofran and conflicting studies that cannot rule out dangers to a fetus. Koren is affiliated with The Motherisk Program, The Hospital for Sick Children and the University of Toronto, Canada.

The study of 900,000 Danish women in August 2013 review found “2-fold increased risk of cardiac malformations with ondansetron (Zofran), leading to an overall 30% increased risk of major congenital malformations”.

“Around 80% of pregnant women suffer from NVP, and about 1 million pregnant women are exposed to Zofran and its generic version every year”, Koren reported.

The study also compared Zofran to Metoclopramide, another drug used to treat NVP that was not associated with birth defects in the first trimester. Study authors say there are other safer FDA-approved treatments for NVP, such as doxylamine and pyridoxine.

“There is no reason for women to be exposed to a drug of unproven maternal and fetal safety when there are safer options currently available”, Koren wrote.

Zofran birth injury lawsuits

Although some pregnant women have found that Zofran eases their nausea and vomiting significantly, others have filed zofran birth injury lawsuit against its maker, GlaxoSmithKline. In fact, the lawsuits aren’t limited to mothers who once took the medication. In 2012, the United States Department of Justice filed a lawsuit against Glaxo, which eventually ended in a $ 3 billion settlement.

According to court documents, the government filed a claim against Glaxo after it engaged in promoting off-label use of several drugs, including Zofran.

Recently, a myriad of women in Canada came forward after experiencing adverse affects from Zofran. Along with the risks of birth defects in their infants, other side effects that directly affect the mother include:

a) Irregular heartbeat

b) Body swelling

c) Shortness of breath

d) Constipation

e) Fainting

f) Rashes, hives and itching

At least 20 Canadian women experienced severe side effects, including one infant who died, as per FDA reports. Four infants that were born to the mothers who took Zofran, weighed around 4 pounds at birth, and six infants were said to have “fetal growth restriction”.

Financial compensations may be available through Zofran birth injury lawsuits, as many of these severe health problems could have been avoided if GlaxoSmithKline had properly researched the pregnancy risk associated with the medication and warned about use of off-label Zofran for morning sickness.

>Although some pregnant women have found that Zofran eases their nausea and vomiting significantly, others have filed zofran birth injury lawsuit against its maker, GlaxoSmithKline.

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