Zofran Birth Defects

Concerns have been raised about the possibility that Zofran side effects could include a risk of birth defects when mothers were prescribed Zofran to treat morning sickness. Although studies have produced conflicting results about the risk of Zofran birth defects, one news investigation has reportedly turned up reports of heart defects and kidney malformations in newborns who were exposed to Zofran prior to birth. The US Food and Drug Administration (FDA) has issued warnings about the risk of serious Zofran adverse events.

Zofran (known generically as ondansetron or ondansetron hydrocholoride) is approved by the FDA to prevent nausea and vomiting linked to cancer chemotherapy, radiation therapy and surgery. It is often prescribed off-label to treat morning sickness in pregnant women. Zofran is in a class of medications called 5-HT3 receptor antagonists and is given either orally or through an injection.

In 2011, the FDA issued a warning that use of Zofran could result in an abnormal heart rhythm, including QT interval prolongation and Torsade de Pointes. The FDA advised patients with congenital long QT syndrome should not be treated with Zofran. Additionally, the agency required GlaxoSmithKline to conduct a thorough QT study to determine the degree of risk.

Studies concerning Zofran and birth defects have returned conflicting results. One study, published in The New England Journal of Medicine (2/28/13) found no link between the use of Zofran while pregnant and an increased risk of spontaneous abortion, still birth or major birth defects. A different study based on the same database used for The New England Journal of Medicine Study, but covering a longer period reportedly suggested a two-fold risk of cardiac birth defects.

That second study was presented at the International Society of Pharmacoepidemiology in Montreal in 2013. Researchers found that women who took a different drug, metoclopramide, had no increased risk of having a baby with birth defects.

In 2014 a Canadian newspaper, The Toronto Star (6/25/14) undertook an investigation of Zofran. The investigation found that at least 20 Canadian women who used ondansetron while pregnant experienced fetal side effects, including infant death, low birth weight, and heart and kidney defects. The heart defects included heart murmur and atrial septal defect.

Concerns have also been raised about the risk of serotonin syndrome in pregnant women who take a selective serotonin reuptake inhibitor (SSRI) and Zofran or another 5-HT3 receptor antagonist at the same time. The concern is that both types of medication modify the amount of serotonin in the patient's brain, which could lead to serotonin syndrome, a potentially fatal condition. Symptoms of serotonin syndrome include confusion, agitation, lethargy, coma, hyperthermia, nausea, vomiting and tremors.

According to a report from the FDA, as of February 13, 2013, the agency had received 39 reports of serotonin syndrome linked to ondansetron.

In 2012, the US Department of Justice announced that GlaxoSmithKline, maker of Zofran, would pay more than $1 billion to settle claims that it illegally marketed Zofran and other medications for off-label, unapproved uses. Specifically, GlaxoSmithKline allegedly "promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women." Although doctors are free to prescribe Zofran for off-label use, it is illegal for a drug company to market its medications for unapproved uses.

Zofran Birth Defects Legal Help

If you or a loved one has suffered similar damages or injuries, please click the link below and your complaint will be sent to a Drug and Medical Device lawyer who may evaluate your claim at no cost or obligation.

Last updated on Feb-3-15