Zofran is a very strong anti-nausea prescription medicine that has been widely used off-label for pregnant women. There has been an increased risk of birth defects linked to using this medicine while pregnant. Pregnant mothers suffering from morning sickness should be aware of the research linking a risk of birth defects to Zofran use.
Zofran was developed by GlaxoSmithKline in the 1980s. It was approved by the FDA in 1991, but the approval was limited to the treatment of nausea and vomiting in patients after surgery and for radiation and chemotherapy patients. It became a big seller in the United States, earning $1.3 billion during the first three quarters of 2006. During the last quarter of that same year, Zofran’s patent protection expired and approval of a generic version was granted by the FDA.
Off-Label Marketing of Zofran
After a generic version of Zofran became available to cancer patients, GlaxoSmithKline started to explore other markets for the drug. From 1983-2013 there was not a drug for morning sickness that had been approved by the FDA. That’s when the drug maker started its marketing campaign targeting women suffering from morning sickness, including the more severe type of morning sickness, hyperemesis gravidarum.
Birth Injury Risks of Zofran
Even though Zofran has been prescribed for treating morning sickness, the drug label doesn’t provide a list of the increased risk of potential birth defects. Because of this, there has been a growing list of lawsuits that allege the drug maker marketed Zofran illegally and was negligent in not warning consumers and health care workers about the risks of using it while pregnant.
Data from recent studies has detected an increasing risk of birth defects when pregnant mothers took Zofran for morning sickness. Some of these defects include:
- cleft lip
- cleft palate
- heart defects
- renal agenesis (baby born with only one kidney)
Medical Studies on Zofran
As previously stated, Zofran has not been approved for treating morning sickness. Also, not much is known about how safe Zofran is to use during pregnancy. The studies that have been done are suggesting that using Zofran increases the risk of major birth defects, especially when used in the first trimester of pregnancy. The unfortunate fact is that morning sickness is usually the worst during the first trimester, making it very likely that it will be prescribed during that extremely critical time of the baby’s development.
A Danish study in 2013 looked at a registry of 900,000 birth records that ranged from 1997 to 2010. The study found a 30% risk increase of birth defects and a doubled increase in heart defect risks linked to the mother using Zofran.
A safety warning was issued by the FDA in 2012 that warned patients using Zofran about the increased risk of suffering from Torsade de points, a potentially fatal arrhythmia of the heart. The warning also recommended that patients with a certain type of electrolyte abnormality caused by severe vomiting and nausea, should have their ECG be monitored while using Zofran.
If you or someone you love has taken Zofran during pregnancy and the baby was born with a cleft lip, cleft palate, or a kidney or heart problem, you need to speak with an experienced personal injury lawyer as soon as possible.
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