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Sheller, P.C.
Sheller, P.C.
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Morning Sickness Drug Zofran Linked to Birth Defects

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Zofran, a widely used drug for morning sickness and nausea, which is often prescribed to pregnant women, might increase the risk of birth defects as well as cause injury to the mother, according to the findings of a new and recent study.

Zofran, made by drug giant GlaxoSmithKline is also available in generic form, ondansetron. The medication works by affecting serotonin levels in the brain and was approved in 1991 to treat vomiting and nausea in cancer patients. But doctors regularly prescribe it “off-label” to treat vomiting and nausea during pregnancy (NVP).

A study in the December 2014 issue of American Journal of Obstetrics, by Dr. Gideon Koren, highlights the serious risks of pregnant women taking Zofran as well as conflicting studies that can’t eliminate the risk to a fetus.

The study involved 900,000 Danish women in August 2013 and found “2-fold increased risk of cardiac malformations with Zofran, leading to an overall 30 percent increased risk of major congenital malformations.”

An estimated 80 percent of pregnant women suffer with NVP and nearly 1 million pregnant women are exposed to Zofran as well as its generic version, yearly, Koren said.

The study compared metoclopramide to Zofran which is another drug also used for NVP but that has not been associated with birth defects in the first trimester. The study authors advise that there are other, safer, FDA-approved treatments for NVP and advises talking to you your medical doctor.

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

Several Zofran lawsuits have been filed on behalf of children, alleging that the manufacturer failed to adequately warn about the risks associated with use of the drug during pregnancy.