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.
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Zofran Side Effects
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.
Zofran 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.
Zofran and Serotonin Syndrome
According to a report from the FDA, as of February 13, 2013, the agency had received 39 reports of serotonin syndrome linked to ondansetron.
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