Zofran Dangerous Drug Side Effects

If you are pregnant and planning to become pregnant, you want to protect the health of your unborn baby. You should know that medical researchers are raising questions about the use of the potentially dangerous drugs anti-nausea drug Zofran to treat pregnant women experiencing severe morning sickness and its link to birth defects in children.

Zofran, which is manufactured by GlaxoSmithKline, was originally approved in 1991 to treat nausea and vomiting in cancer patients undergoing chemotherapy and radiation. The medication is also known as ondansetron. Doctors often prescribe the drug to women to treat nausea and vomiting during pregnancy, although the Food and Drug Administration never approved it for that purpose.

The problem, according to the DrugWatch website, is that a recent study suggests use of ondansetron increases the risk of severe birth defects and injury to the mother.

A study that appeared in the American Journal of Obstetrics and Gynecology in December 2014 said there is no valid reason for women to be prescribed Zofran, a drug of unproven maternal and fetal safety, since the FDA in 2013 had approved another drug specifically for nausea and vomiting linked to pregnancy.

Around 80 percent of pregnant women suffer from nausea and vomiting, and about 1 million pregnant women are exposed to Zofran or its generic version every year, according to the study’s author, Dr. Gideon Koren of The Hospital for Sick Children and University of Toronto in Canada. The study found a “two-fold increased risk of cardiac [heart] malformations with ondansetron (Zofran), leading to an overall 30 percent increased risk of major congenital malformations.”

The report also cites a study by the Sloan epidemiology unit and the Centers of Disease Control and Prevention (CDC) that reports a two-fold increased risk for cleft palate associated with ondansetron taken for nausea and vomiting during pregnancy in the first trimester.

Another 2014 study by Swedish researchers published in the medical journal Reproductive Toxicology reported a statistically significant risk of septal heart defects involving a hole in the wall separating the chambers of the heart in infants born to women who had taken Zofran in the first months of pregnancy.

Previously, the Food and Drug Administration warned that Zofran may affect the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes.

As a result, researchers say, the FDA requires strict workup of patients receiving ondansetron to rule out long QT, electrolyte imbalance, congestive heart failure or taking other medications that prolong the QT interval. But because ondansetron is not approved to treat morning sickness, the warning does not address women with severe NVP, though they often exhibit electrolyte abnormalities (hypokalenia or hypomagnesemia).

Prescribing drugs for unintended or “off-label” uses is a risk that some doctors subject their patients to without adequate explanation or warning.

Pharmaceutical manufacturers are legally required to make and market drugs that are effective and safe, when used as directed. Manufacturers may be held liable if they do not adequately explain the potential adverse side effects of a product.

After a federal investigation, GlaxoSmithKline LLC, the manufacturer of Zofran, agreed in 2012 to pay $3 billion to settle civil and criminal liability related to the illegal marketing of certain prescription drugs including Zofran for off label uses, according to a press release from the U.S. Justice Department. When patients are harmed by the side effects of unsafe drugs, drug manufacturers should be held accountable.

Individuals harmed by drug side effects may be legally entitled to seek compensation for their injuries and medical expenses by filing a dangerous drugs lawsuit.

If you were prescribed Zofran while pregnant and suffered adverse medical conditions, or your baby had birth defects, the birth injury lawyers of Burch George and Germany would like to discuss your product liability case with you at no charge to you. In case you got hurt from defective medical devices, our lawyers can help you file a medical device lawsuit.