A recently published study conducted by researchers from Egypt and from the U.S. showed that the anti-nausea drug ondansetron, which goes by the brand name Zofran, affects the placenta during pregnancy.
Published in the February 2015 edition of Clinical Pharmacology and Therapeutics, the study relied on “plasma samples obtained from 20 non-pregnant and 40 pregnant women following a single administration of 4 or 8 mg ondansetron, from umbilical cord blood at delivery, and from neonates after birth,” reads a part of the study. The drug’s effect “is characterized by rapid transplacental transfer and longer elimination half-life in neonates compared to their mother,” according to the study’s abstract.
The findings are significant because there is some science that links the use of Zofran during pregnancy with birth defects in the baby. Consistent with such results, Zofran lawsuits are being filed in the U.S. in which mothers claim that this GlaxoSmithKline prescription medication caused their children to have birth defects. Experienced and willing to fight for the rights of Zofran victims, attorneys at the law firm of Reich & Binstock are investigating such claims.
Seemingly vindicating many Zofran victims’ claims, the medical journal Reproductive Toxicology zeroed in on Zofran birth defects in its December 2014 edition. An article explained the results of a Swedish study. It read, in part, “Data from the Swedish Medical Birth Register combined with the Swedish Register of Prescribed Drugs were used to identify 1,349 infants born of women who had taken ondansetron in early pregnancy, 1998-2012. … The risks for a cardiovascular defect and notably a cardiac septum defect were increased and statistically significant.”
The aspect that is most interesting about Zofran’s alleged effects on the fetus is that the U.S. Food and Drug Administration did not approve the drug for pregnancy-related nausea.
The FDA originally approved Zofran in 1991. It remains approved for the “prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy” as well as for the “prevention of postoperative nausea and/or vomiting,” according to its label.
So why was it marketed as a “morning sickness” drug, thus exposing the fetus to the allegedly unreasonable risk of birth defects? Frankly, according to the U.S. Justice Department, it shouldn’t have been.
Hence, on July 2, 2012, the Justice Department announced that GSK “agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs,” among other charges.
In the civil portion of the settlement, according to federal authorities, the manufacturer assumed liability for promoting Zofran and a few other drugs “for off-label, non-covered uses and paying kickbacks to physicians to prescribe” Zofran and other drugs. The attorney general’s statement added that the civil settlement “further resolves allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.”
At the time, the criminal and civil resolution was “the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company,” according to the Justice Department.
So we have a drug that was marketed without FDA approval for use by pregnant women, and we have patients’ claims, validated in some medical science circles, that the drug allegedly caused birth defects.
If that problem is not enough, the FDA reported in 2011 and in 2012 that Zofran, at a certain intravenous dose, “may increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm” known as Torsade de Pointes.
The Zofran attorneys at Reich & Binstock are here to help the victims. They have been taking on pharmaceutical companies for the damages inflicted by their drugs since 1984; that is experience one can trust. Anyone who used Zofran during pregnancy and who had a child with birth defects may reach Reich & Binstock for a free consultation either by calling the toll-free number, 1-866-LAW-2400, or by submitting an electronic message through this web page.