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Zofran: Anti-Nausea Medication Not for Pregnant Mothers
Oliver Law Office is investigating cases involving birth defects following maternal ingestion of the anti-nausea medication known as Zofran. Studies now suggest that the drug crosses the placental barrier to the unborn fetus increasing the risk of severe birth defects, including cardiac defects and cleft palate.
Zofran is a 5-HT3 receptor antagonist (also available in the generic form since 2006, “Ondansetron”), and is manufactured by GlaxoSmithKline. Originally approved in 1992 to treat nausea and vomiting in cancer patients or after surgery, it works by affecting serotonin levels in the brain. Many doctors, though, prescribed it to treat vomiting and nausea during pregnancy (“NVP”).
In December 2014, Dr. Gideon Koren published a study in The American Journal of Obstetrics and Gynecology highlighting the risks associated with the ingestion of Zofran by pregnant mothers.
The 2014 published study included 900,000 Danish women and found a two-fold increased risk of cardiac malformations with the use of Zofran.. There was a 30 percent increased risk of major congenital malformations, including cleft palate and other birth defects.
Studies suggest that approximately 80 percent of pregnant women suffer from NVP. Over 1 million pregnant women use Zofran or its generic version every year, Dr. Koren reported.
In the study, Zofran is compared to Metoclopramide--another drug used to treat NVP—which is not associated with birth defects in the first trimester. The authors of this study suggest there are safer, alternative FDA-approved treatments for NVP, including drugs such as pyridoxine and doxylamine.
“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.
New Data differs from prior studies. Prior studies reported no safety issues with the use of Zofran by pregnant mothers. However, the earlier studies were completed with only 176 women suggesting that the sample size was too small for an accurate predictor of birth defects.
In February 2013, a study published in the New England Journal of Medicine included 2,000 Danish women followed between2004 and 2011. Originally, the study also showed that Zofran did not pose a significant risk of harm to fetuses. However, half of the women in the study did not start taking the drug until after 10 weeks gestation. Malformations normally do not develop past this window of time.
After the study was reported, The International Society of Pharmacoepidemiology, presented evidence gathered over 13 years of studies. The ISP study found that 58 women out of 1,248 who took Zofran in the first trimester had a baby born with a birth defect, representing a 30 percent increased risk of harm to the fetus. Glaxo Paid $3 Billion to Settle Zofran Fraud Allegations
The Department of Justice brought charges against the drug maker, GlaxoSmithKline, for unlawful promotion and failure to report safety data of a number of its drugs, including Zofran. The fraud charges included violations of the Food, Drug, and Cosmetic Act relating to three of its drugs. In settlement of those charges, GlaxoSmithKline agreed to pay $1 billion in criminal penalties and another $2 billion in civil penalties to resolve a federal whistleblower lawsuit which included allegations of paying kickbacks to doctors to prescribe Zofran for such off-label use.
Families of babies who suffered birth defects after the use of Zofran are filing suit against the drug maker because of birth defects, including cleft palates and lips, club feet, heart defects and craniosynostosis – a condition in which the skull is abnormally shaped and may not have enough space for the brain. This can cause vision problems, eating issues and mental impairment.
If you or a family member need help or believe you may have a baby born with a birth defect after using the nausea drug, Zofran, call for help today at 614-220-9100 to schedule an appointment.