Zofran is a drug that was approved by the FDA for use among patients undergoing chemotherapy, radiation, and other surgical procedures which cause nausea and vomiting. Zofran has also been prescribed fairly frequently off-label, to pregnant women who experience severe morning sickness. Studies on the risk of birth defects among women taking Zofran have shown conflicting results; one study done in 2013, which was based on 900,000 births, found a 30 percent increase in the risk of Zofran birth defects as well as double the risk of heart defects.
Another study done in 2012 by the Center for National Birth Defects Research and Prevention reported cleft palate birth defects in babies born to mothers who took the drug during the first trimester, noting these cleft palate birth defects were 2.4 times more likely to occur. The Toronto Star went through FDA adverse event reports on Zofran, finding two infant deaths and multiple cases of infants born with kidney and heart defects. GSK’s own fetal safety data is actually based on fewer than 200 births. Animal studies were done on pregnant rabbits and mice with a gestational period of 33 and 21 days, respectively. In these animal studies, Zofran was given after day seven, completely missing the equivalent of a human’s first trimester. It was clear from these studies that Zofran does cross the placental barrier.
How Zofran Works Zofran contains ondansetron hydrochloride dehydrate which is a 5HT3 antagonist. When the brain receives specific nerve messages from the brain, vomiting can result. Radiation and chemotherapy, as well as some other types of surgical procedures, can send serotonin into the stomach and the brain, releasing nausea messages from the brain. Zofran blocks those messages, preventing the patient from suffering nausea and vomiting.
Is Off-Label Usage Allowed?
In the United States, it is considered both legal and ethical for physicians to prescribe drugs for off-label use. Off-label use occurs when any medication is used in a manner not specified under its approval from the FDA. As many as one out of every five outpatient prescriptions written in the U.S. are for off-label use, yet despite this, few patients are aware they may be receiving a drug off-label, as doctors are not legally required to disclose such information.
It is, however, illegal for drug companies to promote off-label use of any drug to physicians, yet Glaxo-Smith-Kline actively promoted Zofran for use among pregnant women, leading doctors to assume it was safe for mother and baby. In 2012, GlaxoSmithKline paid a staggering $3 billion settlement to the U.S. Department of Justice for the off-label promotion of Zofran and other drugs. Despite this, Zofran’s drug labeling includes no warnings regarding the risks of Zofran birth defects, therefore GSK could potentially be held liable for negligent manufacturing, selling, and marketing Zofran without disclosing potential risks.
Zofran Lawsuits Recent Zofran lawsuits charge GSK with failure to warn women who took the drug to control morning sickness of the risks associated with Zofran, particularly when taken during the first three months of pregnancy. The manufacturer also neglected to provide the results of the rabbit and mice research done in the 1980s, which plainly showed Zofran could cross the placental barrier. Finally, GlaxoSmithKline hid more than 200 reports regarding Zofran-associated birth defects. One lawsuit alleges GlaxoSmithKline knew–as far back as 1998–that doctors were prescribing Zofran, off-label, for severe cases of morning sickness and that the drug could cause serious, even fatal birth defects. Many more lawsuits are expected to follow those already filed, with the primary cause of action being failure to warn.
Contact Our Experienced Jackson Dangerous Drug Lawyers If your child was born with a birth defect & you took Zofran during your pregnancy, you need an experienced Jackson Dangerous Drug lawyer on your side. At Coxwell & Associates, PLLC, our law firm has the skills and resources necessary to take on large pharmaceutical companies – and win.
We will fight aggressively for you and your family. Contact Coxwell & Associates today at (601) 265-7766 or (601) 265-7766.
Disclaimer: This blog is intended for general information purposes only, and is not a substitute for legal advice. Anyone with a legal problem should consult a lawyer immediately.