However, It Seems No Further Research About This Congenital Birth Defect Being Caused By Zofran Use During Pregnancy Has Been Done By GlaxoSmithKline
(Posted by Tom Lamb at DrugInjuryWatch.com)
So-called "morning sickness", or nausea and vomiting (NVP), is the most common medical condition of pregnancy, affecting more the 75% of all pregnancies to some degree. In fact, severe NVP, or hyperemesis gravidarum, can be debilitating and require hospitalization.
For many years now, some women with morning sickness have been prescribed Zofran (ondansetron) and had babies born with birth defects and other congenital malformations.
Remarkably, Zofran is not even approved by the FDA as a treatment to reduce morning sickness when women are pregnant. Rather, this GlaxoSmithKline drug has been approved by FDA for the prevention of nausea or vomiting associated with chemotherapy and radiotherapy as well as in some instances following surgery.
As far back as 2004 some medical researchers have noted that while Zofran is being used for morning sickness, or NVP, there have been no sufficient medical studies examining its safety in pregnancy.
From "The safety of ondansetron for nausea and vomiting of pregnancy: a prospective comparative study", published by the medical journal BJOG: an International Journal of Obstetrics and Gynaecology in September 2004, we find this rather alarming (one would think) statement about that situation:
[Zofran (ondansetron)] was never intended or labeled as such to be a treatment for NVP. Consequently, there is a paucity of data in the literature on the safety of [Zofran (ondansetron)] for the treatment of NVP: there are three case reports and one small study comprised of 15 subjects with severe NVP (hyperemesis gravidarum) who were compared with women taking promethazine. [footnotes omitted]
Coincidentally, the two medical journal articles about those case reports and that small study were published in the same year GlaxoSmithKline (GSK) lost its patent protection for Zofran -- and when its equivalent, ondansetron, first became available in the US, and started being sold by generic drug company competitors.
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While the lack of a sufficient Zofran pregnancy-use safety study was certainly pointed out by the authors of that 2004 medical journal article, and they identified hypospadias as a specific "major malformation" which might be associated with Zofran use, it seems that little if any such safety research has been done by the drug company GSK to date -- despite those authors' clear call for such.
From that BJOG medical journal article:
... in the [Zofran (ondansetron)] group, there were three cases of hypospadias, which fit our criteria for major malformation because they required surgery. This is an increase in the rate of hypospadias in the general population (though not statistically significant), where this abnormality occurs in approximately 1 in every 300 males. Of note however, none of these hypospadias were categorized as severe, two of the three were described by the child’s attending physician in the report as minor and one was described as moderate. Our sample size lacked power to show this apparent sixfold increase in this anomaly, thus, was not statistically significant. This increase in the rates of hypospadias was not shown in animal studies. More studies are required to achieve significant power to address any potential association between [Zofran (ondansetron)] and hypospadias. [footnotes omitted]
Meanwhile, as set forth in this earlier article, "Zofran Associated With Birth Defects When Used During Pregnancy As An 'Off-Label' Morning Sickness Treatment":
In 2012, the U.S. Department of Justice reached a $3-billion settlement with GlaxoSmithKline after the government alleged the company promoted the off-label uses of several drugs, including Zofran, the company’s brand-name version of ondansetron.
Court documents alleged the company gave doctors kickbacks to prescribe the drug for morning sickness and disseminated false information about Zofran’s safety and effectiveness.
We are currently investigating possible drug injury lawsuits against GlaxoSmithKline for cases where Zofran used by pregnant women resulted in birth defects, congenital malformations, or deformities in children born to those women.