Zofran Product Alert

The anti-nausea drug Zofran (generic name “ondansetron”) has been reported to cause birth defects in children. Zofran was commonly prescribed by doctors off-label to pregnant women experiencing morning sickness, nausea and vomiting. Children born to mothers who took Zofran for morning sickness, nausea and vomiting during pregnancy should be seen by doctors immediately. Children born to mothers who took Zofran during pregnancy have been linked to an increased occurrence of cleft palate, amongst other birth defects.

GlaxoSmithKline (GSK), the manufacturer of Zofran, developed the drug in the mid-1980’s. Zofran received FDA approval in the early 1990’s, but was limited in its approval to the treatment of nausea and vomiting after surgery, chemotherapy and radiotherapy treatments. However, GSK marketed Zofran off-label to pregnant women as a morning sickness treatment. An off-label treatment is one where a drug, such as Zofran, is approved by the FDA, but is prescribed and used for a purpose other than those specifically identified by the FDA. The FDA must approve not only the drug itself, but its packaging and labeling, as well. Part of the approval process is making sure the label describes the drug’s intended and approved uses.

Doctors are free to prescribe a medication for an off-label use, provided a risk-benefit analysis is conducted and the physician reasonably believes it is medically appropriate. Drug manufacturers are legally barred from marketing their drug for uses other than those approved by the FDA.

As early as 1999, GSK (then known as GlaxoWellcome Inc.) was given a warning for its promotion of Zofran. The FDA doled out the warning for the marketing of Zofran in a false and misleading manner. Glaxo was instructed by the FDA to cease distribution of Zofran’s promotional label and similar materials that failed to list information of Zofran’s side effects and other pertinent information.

In 2012, the FDA issued a warning with respect to long term use of Zofran and its effect on the heart. The FDA warned that Zofran “may increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm.” GSK was required by the FDA to conduct a thorough study to assess the effects of long-term use of Zofran and its effect on QT prolongation. While the label contained language about the risk of long term use, the label was required to be revised to warn about congenital long QT syndrome due to patients taking Zofran being at a particular risk for Torsades.
A study was conducted by the Center for Birth Defects Research and Prevention and published in January of 2012. The Center’s study identified “twofold increased risk for cleft palate associated with ondansetron exposure used for NVP in the first trimester,” Ob. Gyn. News reports. Ondansetron is the generic name for Zofran. Ob. Gyn. News reported that the study conducted linked Zofran to other risks such as cardiac arrhythmia.

GSK plead guilty to criminal charges and paid $3billion in fines due to the improper promotion of its drugs in 2012. GSK was accused of omitting potential serious side effects from labels. In the same timeframe, a civil settlement was reached for the off-label promotion of Zofran, amongst other drugs, and paying kickbacks to physicians who prescribed the drug.

In 2013, the FDA identified Zofran as a potential safety risk. At that time, Zofran was linked to Serotonin syndrome, but the FDA could not identify the strength of the relationship at the time of the warning. Once again, label changes were suggested to Zofran’s manufacturers if the drug was found to pose a safety risk.
A study published in December 2014, known as the “Andersen Study,” exposed the risk of Zofran use by expecting mothers. The European study published in Reproductive Toxicology identifies an increase in birth defects amongst children whose mothers took Zofran for morning sickness, nausea and vomiting during the first trimester. Again, cleft palate was found as a result as well as possible effects on the heart.

Lawsuits have been filed against the makers of Zofran, GlaxoSmithKlein. Recently, Multi District Litigation was granted to consolidate all lawsuits suits under one judge on the United States District Court, 1st Circuit in Boston, Massachusetts.

If you or a loved one took Zofran during pregnancy and subsequently gave birth to a child with cleft palate, congenital heart defects or other birth defects, contact a physician immediately.

Close up view of pills spilling out of a prescription bottle on a blue background

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