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Most Women Aren’t Warned of Zofran Birth Defects

A class action Zofran lawsuit was recently filed against GlaxosmithKline (GSK) by a group of Canadian women who say they were never warned about the dangers of taking the medication while pregnant, including the risks of their infants developing birth defects. Not being warned of the potential dangers of Zofran seems to be a common occurrence with the numerous plaintiffs across the U.S. and Canada who were prescribed the drug for morning sickness.

One of the mothers included in the class action lawsuit, Terra Mercer, stated that she wanted a pregnancy without any drugs, but when her morning sickness became severe, she began taking Zofran, a popular anti-nausea medication that’s only approved for use by surgery and chemotherapy patients. Before she agreed to take Zofran, she specifically asked her doctor if the medication was safe.

“Before I said yes, I first asked if there were any side effects. He said. ‘No, it’s safe.’ So I trusted him.”

Yet, when Mercer’s daughter was born, the infant was diagnosed with cleft lip and cleft palate, two birth defects associated with taking Zofran while pregnant. As a result, the baby girl must endure numerous surgeries to correct the defects.

Mercer, like many other women who’ve filed a lawsuit against GSK, the makers of Zofran, feels that the medication is what caused the birth defects. As with other women who’ve had babies with birth defects, Mercer indicates that she would have never taken the medication had she known the risks.

According to an attorney who specializes in Zofran cases, manufacturers who fail to warn patients about the potential side effects of taking a certain medication may be liable for damages should birth defects or any other injuries related the drug occur.

“The real heart of this case is the warning about this information should be made available to health care providers and in turn, to the mothers carrying these children.”

Yet, GSK still hasn’t done the type of in-depth studies needed to determine the safety of Zofran. According to the company’s website,

“The safety of ondansetron for use in human pregnancy has not been established. Ondansetron is not teratogenic in animals. However, as animal studies are not always predictive of human response, the use of ondansetron in pregnancy is not recommended.”

Regardless, numerous independent studies have been performed on Zofran and indicate that there are heightened risks of certain types of birth defects, including cleft lip, cleft palate, heart abnormalities, hearing and vision problems and more. The U.S. Food and Drug Administration (FDA) also warns that there are possible risks when taking Zofran while pregnant.

Dr. Nav Persaud, a research scientist with St. Michael’s Hospital, states that more research should be performed on Zofran and until then, women experiencing severe morning sickness should be offered different alternatives.

“All women should be presented with a variety of options including non-medical treatments for nausea and vomiting and also the several different medications that could be taken.”

If you took Zofran while pregnant and your infant developed birth defects, keep in mind that you have the legal right to seek compensation from the responsible party.