A team at Harvard University found that women prescribed Zofran’s active ingredient were 37 times more likely to be born with this condition, which occurs when the roof of a child’s mouth fails to close properly during the first trimester.
Taking Zofran in any form while pregnant is a serious concern as the drug travels into the placenta when used in the first trimester, which means it can be a danger or risk to the developing fetus.
If you or someone you know was prescribed Zofran for morning sickness during the first trimester of pregnancy and had a baby with a heart defect, cleft palate, cleft lip, or other birth defects after taking Zofran during the pregnancy, you may be entitled to compensation.
The first study was important in showing no complications in pregnancy from Zofran, but the question of birth defects was not quite answered because half of the patients started Zofran after 10 weeks gestation, which is after the critical time for organ development in the embryo.
You just found out Im pregnant and now you must be wondering about the common side effect of Zofran. Although GlaxoSmithKline did reach a $3 billion settlement with the federal government in 2012 for off-label promotion of drugs, including Zofran as a treatment for morning sickness, no known Zofran settlements have been reached with individual claimants as of June 20.
There is, however, an FDA “Pregnancy Category A” drug called Diclegis, which has been recently approved to treat nausea and morning sickness in pregnant women.
Although it is not approved for use by pregnant women, Zofran is sometimes prescribed off-label to treat morning sickness during pregnancy, including a severe form called hyperemesis gravid arum.
In their investigation, the Star found 20 cases where Canadian women were treated for morning sickness with Zofran and delivered children with various birth defects, such as heart defects and kidney malformations.
Decades later, “pregnant women may be the most underrepresented group in the entire clinical research process,” a 2011 report by the National Institutes of Health’s Office of Research on Women’s Health declared.
But recent research has found Zofran linked to birth defects, including increased risks for congenital heart defects and cleft palate.
This has led to Zofran lawsuits accusing the drug maker of illegally marketing Zofran for morning sickness and negligently failing to warn consumers and the medical community about the true risks of Zofran pregnancy use.
The FDA did not review Zofran’s safety for use by pregnant women suffering from nausea during pregnancy.
It hasn’t been evaluated for safety in pregnant women and has been linked to an increased risk of serious birth defects.
Since this safe and effective drug is available, there is no reason for women to be exposed to Zofran due to safety concerns for the mother and child.
Drug companies are not eager to do prospective studies in pregnant women if they guess wrong and there is a birth defect connection the legal implications would be huge.
Although Zofran was only approved for use among chemotherapy patients and surgical patients, the medication has been illegally marketed for “off-label” use as a morning sickness drug by pregnant women, even though GlaxoSmithKline failed to establish that it is safe for the fetus.
At least four studies have indicated that the use of Zofran or its generic version by pregnant women in the first trimester may lead to an increased risk of serious birth defects.
Many studies have been done that indicate taking Zofran during pregnancy could cause birth defects or malformation to occur in an unborn child.
GSK did not perform any studies or research on the effects of Zofran on pregnant women or the fetus prior to marketing it for this “off-label” use.
A 2014 investigation by the Toronto Star found at least 20 Canadian women had reported serious Zofran side effects to the US.
However, doctors may choose to prescribe these drugs to pregnant women even without that approval.