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article imageCanadian women file class-action lawsuit over anti-nausea drug

By Karen Graham     Dec 8, 2015 in Health
A class-action lawsuit has been filed in Canada by women who say their babies were harmed after the women took a powerful anti-nausea drug that was not technically approved for use during their pregnancies.
Even though there have been a growing number of lawsuits against GlaxoSmithKline (GSK) alleging birth defects from women using Zofran, the drug is still being prescribed by many doctors in Canada and the United States.
Zofran, also called by its generic name, ondansetron was first approved by the U.S. Food and Drug Administration (FDA) in 1991, for the treatment of nausea and vomiting in patients recovering from surgery or chemotherapy. The drug works by blocking serotonin, a neurotransmitter in the body that causes vomiting.
Zofran is now available in intravenous and pill form in Canada, says CTV News, and is supposed to be used as the FDA approved the medication. But soon after it got approval from the FDA, GSK began marketing the drug for morning sickness. By 1992, according to court documents, GSK began receiving reports from OB/Gyns who noted birth defects in children born to women who had taken Zofran during pregnancy.
This should have raised red warning flags, but apparently, nothing happened, and now, over one million women every year are prescribed Zofran to treat morning sickness. The biggest problem with Zofran is that is is being prescribed "off-label," which is legal. This method of prescribing is at a doctor's discretion, but Zofran is being linked to birth defects.
GSK's patent ran out in 1996, and the FDA approved the first generic versions of ondansetron the same year. GSK, meanwhile, continued to market and sell Zofran. In 2006, Zofran was one of the top 20 drugs sold in the U.S., giving GSK sales of over $1.3 billion in the first nine months. Many of the sales were to pregnant women using the drug as an anti-nausea medication.
Canadian lawsuits
There are now over a dozen Canadian women who have filed a lawsuit against two companies who make the drug, ondansetron. In 2012, Canadian records show at least 20 women treated with Zofran for vomiting in pregnancy experienced serious side effects such as heart defects, malformations, and even infant deaths, possibly linked to the drug.
The FDA received at least 8,682 reports of adverse events linked to Zofran between Jan. 1, and April 30 of 2015. Of that number, 475 cases (5.4 percent) involved birth defects that included everything imaginable, from cleft lips and cleft palates to heart and kidney defects, including deaths.
While some doctors believe that Zofran is not linked to birth defects, other studies have proven there is a relationship between taking this medication and a rise in the number of birth defects, especially when the drug is used during the first trimester of pregnancy. While the percentage of children born with birth defects may seem low, ranging from 1.5 to 4.7 percent, depending on the study, even one child born with a birth defect that could have been prevented is one too many.
More about antinausea drug, zofran, Pregnant women, Birth defects, Glaxosmithkline
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