zofran and breastfeeding
If you wish to know, Is Zofran safe during breastfeeding, then it must be said that enough studies have not been carried out sufficiently to identify the link between ondansetron and breastfeeding. Drug labels do not include warnings about the risk of Zofran birth defects, especially when taken during the first trimester.
The report showed that 1,248 pregnant women were prescribed Zofran for morning sickness or hyperemesis gravid arum during their first trimester. Many pregnant women on Zofran are also treated with antidepressants, which might increase the risk of this side effect. It is estimated that GlaxoSmithKline earned millions of dollars on sales of Zofran, and that about 1 million women used that drug or a generic version of it each year. The data for the study was gathered from approximately 9,000 pregnant women who took part in the National Birth Defects Prevention Study.
However, six months later, another study based on 900,000 births from the same registry found a 30% increased risk of Zofran birth defects overall, and a doubled risk of heart defects. In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. If you or someone you love took Zofran during pregnancy and gave birth to a baby born with birth defects, contact an experienced birth defect drug lawyer for a free legal consultation. Earlier studies found no safety issues with Zofran, but newer research suggests the early data was not accurate enough to draw good conclusions.
So Zofran and Pregnancy 2015 recommendations clearly state that the doctors must not be advice pregnant woman to consume this drug because it has adverse effect on both the mother and the offspring. “There is no reason for women to be exposed to a drug of unproven maternal and fetal safety” when there are safer options currently available, Koren wrote. The following year, the journal Reproductive Toxicology published research indicating that women who used Zofran during the first trimester of pregnancy doubled their risk of giving birth to babies with atrial septal defects, ventricular septal defects, and other “hole in the heart” malformations.
Ondansetron, the generic name for Zofran, has been assigned to “Pregnancy Category B” by the FDA, which means animal studies failed to demonstrate a risk to the fetus and there were no adequate and well controlled studies in pregnant women at the time it was approved. In 2013, a Danish study involving 600,000 births found there was no significant risk of Zofran birth defects. If you or someone you love gave birth to a baby suffering from a birth defect after the mother took Zofran during pregnancy, contact an experienced birth defects lawyer now for a free legal consultation regarding a potential Zofran Lawsuit.
But the FDA has never approved the drug for use by pregnant women as a morning sickness treatment. Now, numerous Zofran lawsuits are being filed against GSK claiming that women who have taken Zofran during pregnancy have an increased risk for birth defects. January 2016 A federal judge denied GlaxoSmithKline's motion to dismiss Zofran lawsuits, allowing affected families to seek discovery from the drug maker regarding its knowledge of the risks of Zofran birth defects and other matters. The Zofran lawsuit 2015 had been the big news as the mothers who used this medical drug gave birth to the children with certain facial and dental defects that they will have to carry till eternity.
In the United States, lawsuits have been filed by families of women who used Zofran during pregnancy and then produced children who had birth defects including cleft lip, cleft palate and heart defects.
They say that the drug company has been aware of Zofran's potential to increase birth defect risks for two decades. There is no data on using Zofran while breastfeeding in humans but early research shows that ondansetron and its metabolites are excreted into the milk of rats.