The Short of It
At least four studies have indicated that the use of Zofran or its generic version by pregnant women in the first trimester may lead to an increased risk of serious birth defects.
Zofran, the name brand for ondansetron, was originally approved for the treatment of severe nausea and vomiting in patients undergoing chemotherapy, radiotherapy and surgical anesthesia, but since its release in 1991, it also has quickly gained popularity as an "off label" treatment for morning sickness during the first trimester of pregnancy. GlaxoSmithKline, maker of the medication, denies that it unlawfully promoted this use, but it ultimately settled for $3 billion for the U.S. Department of Justice's case allegeding it prepared marketing materials for obstetricians and gynecologists that presented Zofran as a safe, effective treatment for morning sickness.
With the number of prescriptions for Zofran's unapproved use during pregnancy estimated at around 1 million every year, researchers are now investigating the drug's potential effects on developing babies in utero:
- A study conducted by researchers at Harvard University, the U.S. Centers for Disease Control, and the Slone Epidemiology Center found that women who consumed ondansetron during their pregnancy were more than twice as likely to give birth to a child with cleft palate.
- A study published in 2013 in BioMed Research International linked Zofran use during the first trimester of pregnancy to an increased risk ofmajor birth defects, preterm birth and shorter birth length.
- Danish researchers found that babies who were exposed to ondansetron in utero were more than twice as likely to be born with atrial and ventricular septal defects and more than four times as likely to have atrioventricular septal defects.
- In 2014, research appearing in the journal "Reproductive Toxicology" found that babies who were exposed to Zofran during early pregnancy faced a statistically significant increased risk for cardiovascular defects, notable cardiac septum defects.
Children who were born with serious birth defects allegedly due to prenatal Zofran exposure may be entitled to file claims against GlaxoSmithKline. As such lawsuits mount, court documents allege the drug maker knew about the potential dangers posed to fetuses, reports law firm Bernstein Liebhard LLP. One complaint says that animal studies conducted in the 1980s revealed that the active ingredient in Zofran crossed the placental barrier to the fetus, and indicated "toxicity, intrauterine deaths and malformations in offspring." Another contends that by 2000, the company had received at least 32 reports of Zofran birth defects—and at least 200 more to date—yet these reports were never disclosed to the very physicians who were prescribing the medication.
Pregnant women should discuss with their doctor whether any medication they are considering taking is approved for use during pregnacy, as well as what its potential side effects are for them and their babies. Doing your own research so you know what questions to ask your doctor is also a smart way to protect your health and that of your fetus.
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