Zofran, a popular anti-nausea medication that’s only approved for use by cancer patients and those undergoing surgery, is being prescribed to pregnant women as an “off-label” use for morning sickness. Although the medication may help control nausea and vomiting, it comes with a harsh price: babies are being born with birth defects.
Studies on Zofran and Birth Defects
Numerous of studies on Zofran and its effects on infants have been performed over the past decade. Even though some of the results are conflicting, the majority of studies show there is a heightened risk of babies developing birth defects if their mothers took the medication while pregnant.
For instance, in August 2013, a group of Danish scientists and researchers published the results of their study in which they recorded live births from 1997 to 2011, Entitled Ondansetron Use In Early Pregnancy And The Risk Of Congenital Malformations, more than half of the women included in the research took Zofran during pregnancy.
The results of the study show that there is a 20% increase in infants developing major congenital abnormalities. The risk of developing congenital heart defects in particular significantly higher, including:
- 8 times higher risk of developing atrioventricular septal defects
- 3 times higher risk of developing ventricular septal defects
- 1 times higher risk of developing atrial septal defects
In November 2013, BioMed Research International, an open-access medical journal, published the results of a Zofran study carried out by numerous Australian physicians and scientists who aimed to determine the risks that babies face when their mothers take the medication during pregnancy.
According to the results, which studied every birth in Western Australia from 2002 to 2005, there is a “20% increased risk of a major birth defect amongst children exposed to ondansetron in the first trimester,” and an increase of kidney defects risks by 7-fold.
Perhaps one of the most popular studies on Zofran and pregnancy was conducted by Dr. Gideon Koren of The Hospital for Sick Children and University of Toronto. In 2014, Dr. Koren, who gathered the statistics and information from numerous other studies, stated that previous studies which showed conflicting results on Zofran and pregnancy were mainly performed on women who were more than 10 weeks pregnant.
Dr. Koren indicated that when additional studies were added that included women in their early first trimester, the results became more troubling, including a twofold increased risk for cleft palate, a 30% increased risk for heart defects, cardiac arrhythmias, and for the mothers of the infants, the risk of developing serotonin syndrome.
What Can Be Done?
Currently, many physicians are still prescribing Zofran to pregnant women, despite numerous studies that show the dangers to infants. The key to helping women is spreading the information about the drug, and promoting awareness as much as possible.
For women who’ve already experienced the devastating effects of giving birth to a child with birth defects, there are legal options available to help them obtain justice and compensation for the overwhelming medical expenses that typically come with birth defect treatments.
The most optimal option, of course, is prevention. Yet, until Zofran is completely banned from being prescribed as off-label use for morning sickness, pregnant women will be offered it, as GlaxoSmithKline (GSK), the makers of the medication, allegedly offers “kickbacks” to physicians who prescribe it for morning sickness.
If you are pregnant, plan to become pregnant, or know anyone friends who are or plan to become pregnant, be certain to educate yourself as much as possible on the effects of unsafe medications and spread the word.