Zofran Birth Defects: Dangers

By Andrew Sullo


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If your baby was born with a birth defect and you were prescribed Zofran for severe morning sickness, it could be beneficial to speak to a Zofran birth defect lawyer. Zofran reduces the severe nausea and vomiting which often result from chemotherapy, radiation and some surgical procedures. The drug is approved for these uses, yet is often prescribed off-label to pregnant women experiencing severe morning sickness (hyperemesis gravidarum).

Although some studies have shown little risk of birth defects when Zofran is used to treat morning sickness, other studies have shown significant Zofran birth defect dangers. One 2013 study based on 900,000 births found a 30% increased risk of Zofran birth defect risks overall as well as double the risk of heart defects. A 2012 Center for National Birth Defects Research and Prevention study reported a 2.4 times increase risk for Zofran cleft palate birth defects and a 2014 investigation by the Toronto Star reported two infant deaths and multiple cases of Zoran birth defects.

More recently, the Toronto Star went through FDA reports, finding that at least twenty pregnant Canadian women suffered harm to their baby after taking Zofran during their pregnancy. These side effects included two infant deaths and multiple cases of infants being born with kidney and heart defects. Although a limited number of studies have not shown a definitive link between Zofran and birth defects, many more have shown the link.  As an example, a study published in the prestigious New England Journal of Medicine found Zofran safe for fetuses, but another study contradicted those findings.

 

How Does Zofran Work?

Zofran comes in tablets, syrup and in an injectable form, all of which contain ondansetron hydrochloride dehydrate, a 5HT3 antagonist. Vomiting is controlled by the brain’s centre, and is activated when it receives nerve messages from the stomach and the chemoreceptor trigger zone of the brain. Chemotherapy, radiation and some types of surgical procedures can cause serotonin (5HT) to be released into the stomach and into the CTZ section of the brain, sending nausea messages to the brain. Zofran blocks the 5HT3 receptors found in the brain and stomach, effectively preventing these nausea messages.

 

Zofran Birth Defect Dangers

There are a number of Zofran birth defect risks including Zofran heart related birth defects, Zofran cleft palate birth defects, Zofran kidney birth defects, Zofran musculoskeletal birth defects, Zofran fetal growth birth defects and even Zofran fetal death. In the Canadian study four infants born to mothers who took Zofran weighed about four pounds at birth while another six had what was classified as “fetal growth restriction.” In 2012 alone, over 190 calls from frantic, worried mothers came in to MotherRisk, a Canadian organization which assists pregnant mothers with their questions and concerns regarding the risks of Zofran. One study found a 2.4 times increase risk of Zofran cleft palate birth defects among mothers who took the drug during the first trimester for severe nausea. Kidney defects, musculoskeletal defects, poor fetal growth and fetal death have also been noted in certain instances among babies whose mothers took Zofran. 

 

Why are Doctors Prescribing Zofran for Morning Sickness?

It is considered completely legal and ethical for doctors to prescribe drugs for off-label use. In fact, more than one in five outpatient prescriptions written in the United States are for off-label usage. Off-label means the medication is being used in a manner not specified in the FDA’s approved packaging or label. This packaging or label is essentially a written report which is based on the results of clinical studies conducted by drug makers.

Because GSK actively promoted Zofran for use in pregnant women years ago, physicians likely assumed it was safe for mother and baby. Despite the prevalence of off-label drug use, few patients are aware they may be receiving a drug off-label as doctors are not legally required to disclose this information. However, since the drug labeling does not include warnings regarding Zofran birth defect risks, the manufacturer of Zofran could potentially be held liable for negligently manufacturing, selling and marketing a drug without properly disclosing the risks.

In the end, Zofran was not approved for use during pregnancy, and the fetal safety data provided by GSK is based on fewer than 200 births. The FDA classifies Zofran as a Pregnancy Category B medication, meaning animal studies have found no evidence of risk, but no one really knows whether the drug is safe. These animal studies were done on pregnant rabbits and mice. Mice have a gestational period of about 21 days, while rabbits have a gestational period of around 33 days. In all four studies done on these mice and rabbits, the Zofran was administered after day seven, meaning the equivalent of the human’s first trimester was completely missed. These studies were used to gain FDA approval and to make the claim that studies show no apparent harm to unborn babies when the mother takes Zofran.

 

Could You Benefit From Speaking to a Zofran Birth Defect(s) Lawyer?

If you were prescribed Zofran during your pregnancy—particularly the first trimester—you could potentially benefit from speaking to a knowledgeable Zofran birth defect(s) lawyer. Zofran birth defect risks have been noted in clinical studies. If took Zofran and your baby was born with a birth defect, it could be beneficial to speak with a knowledgeable Zofran Birth Defects Attorney. Sullo & Sullo, LLP, is currently accepting Zofran birth defects cases.

 

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