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Pregnancy side effects of Zofran, an anti-nausea medication commonly used for morning sickness, may increase the risk of children suffering severe and debilitating birth defects.
STATUS OF ZOFRAN LAWSUITS: As a result of GlaxoSmithKline’s failure to adequately research their medication or warn about the risk of congenital malformations, potential Zofran birth defect lawsuits are being pursued by families of children throughout the United States who have developed:
- Cleft Lip
- Cleft Palate
- Heart Defects
OVERVIEW: Zofran (ondansetron) is a prescription medication introduced in 1991 for treatment of nausea and vomiting associated with chemotherapy or following surgery. However, it has been widely prescribed off-label for morning sickness in pregnant women, despite a lack of evidence to establish that it is safe for the unborn child.
The medication can be administered as a pill, oral solution or as an injection. Zofran is a member of a class of drugs known as 5-HT3 receptor antagonists, and works by blocking the actions of serotonin.
Several studies have raised concerns about the risk of Zofran side effects causing unborn children to suffer various birth defects or malformations, including cleft palate, cleft lip and congenital heart problems, such as atrial septal defects or ventricular septal defects.
Use of Zofran has also been linked to a risk of serious and potentially life-threatening heart rhythm problems for users.
ZOFRAN BIRTH DEFECT RISKS: Although Zofran has never been approved for use by pregnant women, it is widely promoted as a morning sickness drug.
For years, the only basis for the safety of Zofran in pregnancy was a small 2004 study published in the BLOG: An International Journal of Obstetrics and Gynaecology, which involved only 176 women using the drug.
While the research found no statistically significant differences in the rates of major malformations between women prescribed Zofran and other groups, the limits of the study were only able to rule out a 5 times risk.
As early as 2006, a study from Hong Kong found evidence that Zofran crosses the placenta when taken by pregnant women. At the time, researchers called for more studies to be conducted on the fetal effects of Zofran on unborn children.
In 2011, as part of the National birth Defects Prevention Study, researchers from Boston found an association between the use of Zofran and an increased risk of birth defects. The finding came as researchers were looking to see if nausea and vomiting in pregnancy itself, commonly referred to as “morning sickness” was linked to birth defect risks. Instead, they found that women who took Zofran had more than double the risk of giving birth to a child with cleft palate malformations.
The next year, Dr. Gideon Koren, director of the Motherrisk Program in Canada, noticed an increase in the prescription of Zofran to pregnant mothers to combat morning sickness, and warned against the drug’s use during pregnancy citing both a risk of birth defects that could affect the child, and heart problems that could affect the mother.
In February 2013, a historical cohort study involving more than 600,000 pregnancies in Denmark was reported to find that there was no link between Zofran and birth defects. However, experts have pointed out that the average gestational age of exposure to Zofran was 10 weeks, so more than half of the women involved took Zofran after the baby was no longer at risk of congenital malformations during the first trimester.
This same data was examined by another group of researchers in August 2013, which involved 900,000 pregnancies over a longer period of time. That study found that Zofran doubled the risk of heart defects (PDF) and may be associated with a 30% increased risk of birth defects overall.
In 2013, Dr. Koren again warned in Pediatric News about the unknown pregnancy risks with Zofran. He indicated that most clinicians appeared to be ignoring or unaware of the risks and called for more monitoring of pregnant women on Zofran, noting that electrolyte imbalances could leave them more vulnerable to Zofran heart problems.
More recently, in 2015, Swedish researchers published a study in Reproductive Toxicity which found that women who took Zofran during pregnancy were 62% more likely to give birth to children with cardiovascular defects.
In October 2015, the U.S. Judicial Panel on Multidistrict Litigation decided to centralize all Zofran lawsuits pending throughout the federal court system before one U.S. District Judge in Massachusetts for coordinated discovery and pretrial proceedings.
ZOFRAN HEART SIDE EFFECTS: Although warnings have indicated a potential risk of heart rhythm problems on Zofran, known as QT prolongation, the FDA required additional information be placed on the drug in September 2011.
Zofran has been linked to a risk of changes in the electrical activity of the heart, which can cause prolongation of the QT interval of a electrocardiogram (ECG). This may result in an abnormal and potentially fatal heart rhythm, such as Torsade de Pointes.
Updated Zofran warnings indicate that the medication should not be used in patients with congenital long QT syndrome because they may be at a particular risk of Torsade de Pointes from Zofran.
At that time, the labels were also updated to recommend ECG monitoring in patients with electrolyte abnormalities (e.g. hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation.
GlaxoSmithKline was also ordered to conduct additional studies to assess the risk of QT prolongation from Zofran.
A Zofran recall for a 32 mg single, intravenous dose was ultimately issued due to the heart side effects. Adults and children suffering from nausea and vomiting caused by chemotherapy can continue to receive the lower dose of 0.15 mg/kg, administered every four hours for three doses. The update does not change any recommendations for oral dosing regiments.