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Consumer Alert: Popular Anti-Nausea Drug Zofran Linked to Birth Defects
July 2, 2015
A common prescription drug called Zofran (generic name: ondansetron), used to combat morning sickness during pregnancy, has been linked with serious birth defects like heart malformations and cleft palette. We are investigating cases where a mother took Zofran during early pregnancy, and the child was born with birth defects. If you or someone you know has given birth to a child with a birth defect after taking Zofran during pregnancy, please call us at 1.800.553.9910 or contact us here.
Zofran is not FDA-approved for use during Pregnancy
Zofran (ondansetron) is an anti-emetic, used to prevent or treat nausea and vomiting. It is a 5-HT3 receptor antagonist, which works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting. Developed and manufactured by GlaxoSmithKline (“GSK”) to treat nausea and vomiting following cancer treatment, Zofran was approved for use in 1992. It is currently FDA-approved for use after chemotherapy, radiotherapy, or surgery. It is not FDA-approved for nausea and vomiting associated with pregnancy. When a drug is prescribed for an unapproved use, it is called an “off label” use. While doctors can legally write off-label prescriptions, drug manufacturers are generally prohibited from promoting or marketing drugs for off-label uses.
Zofran’s Manufacturer Settled a Case Involving “Off Label” Marketing of Zofran to Pregnant Women
However, in 2011, the United Stated Department of Justice sued GSK for illegally marketing various drugs, including Zofran. The Department of Justice claimed GSK promoted Zofran for morning sickness and offered kickbacks to doctors for prescribing Zofran, in addition to other off-label drug promotion and kickback schemes for other drugs. Eventually, GSK agreed to settle the civil suit - and a related criminal suit – for a record-breaking $3 billion.1 This is the largest health care fraud settlement in U.S. history.
Zofran Linked with Birth Defects
Several scientific studies have linked Zofran use during pregnancy to numerous birth defects. One study published in 2012 found that women who took Zofran were twice as likely to have a child with cleft palate.2 Another study published in August 2013 surveying 897,000+ births in Denmark found a two-fold increased risk of heart defects for women who took ondansetron during pregnancy, a risk which led to an overall 30% increased risk of major malformation.3
No Warning Given About an Increased Risk of Birth Defects
GSK has never warned doctors or patients about the increased risks of birth defects seen in medical studies when pregnant women take Zofran. The drug’s prescribing information notes that studies of pregnant rats and rabbits taking ondansetron showed no evidence of harm to the fetus, but that the drug “should be used during pregnancy only if clearly needed.”4 Meanwhile, it appears that GSK was actively promoting the drug for use in pregnant women.
We will Investigate Your Case for Free
Robins Kaplan LLP is investigating cases in which a child was born with birth defects after the mother took Zofran during her first or early second trimester. We are investing claims involving heart defects, cleft palette, and cleft lip, as well as other birth defects. If you or someone you know has given birth to a child with a birth defect after taking Zofran during pregnancy and you wish to consult with a lawyer, please call us at 1.800.553.9910 or contact us here.
1 Department of Justice, GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data, Department of Justice: Justice News (July 2, 2012), http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report; see http://www.justice.gov/sites/default/files/opa/legacy/2012/07/02/off-label-agreement.pdf. The $3 billion settlement included $2 billion for the civil settlement involving a number of drugs (including Zofran), and a guilty plea plus another $1 billion in fines in a criminal case. The civil settlement does not include an admission of wrongdoing. Documents available at http://www.justice.gov/opa/documents-and-resources-july-2-2012-glaxosmithkline-gsk-press-conference.
2 Marlene Anderka et al., Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects 94(1) Birth Defects Res A Clin Mol Teratol 22 (2011).
3 JT Andersen et al., Ondansetron Use in Early Pregnancy and the Risk of Congenital Malformations – A Register Based Nationwide Control Study, presented at International Society of Pharmaco-epidemiology, Montreal, Canada (2013); Gideon Koren, Scary Science: Ondansetron Safety in Pregnancy –Two Opposing Results from the same Danish Registry, Ther Drug Monit. Vol. 36, No. 1, Feb. 2014;see also Bengt Danielsson et al., Use of Ondansetron During Pregnancy and Congenital Malformations in the Infant, 50 Reproductive Technology 134 (2014) (finding an increased risk for cardiac septum defect).
4 See https://www.gsksource.com/pharma/content/gsk/source/us/en.html
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