Zofran® (ondansetron) is produced by GlaxoSmithKline and approved by the FDA in 1991 to prevent nausea and vomiting that some patients suffer when receiving chemotherapy, radiation or anesthesia. A generic version of this drug was produced in 2001. The product comes of 4 mg, 8mg tablets and in liquid form. The drug was never approved to treat morning sickness and nausea while pregnant, however there is belief that the drug was widely used by for this purpose. In 2012, GlaxoSmithKline, plead guilty and agreed to pay $3 Billion to resolve fraud allegations and failure to report safety data.1 According to the United States Justice Department Press Release, “This settlement resolved allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.” It is important to note that GSK no doubt so a huge opportunity because between 1983, when Bendectin was voluntarily taken off the market by Merrel Dow and April, 2013, when it was reintroduced and approved under the name Diclegis, there was no FDA-approved drug to treat the pregnancy-related symptoms of nausea and vomiting.2
In August, 2013, researchers reported a two-fold increase in cardiovascular defects in children born to mothers who took Zofran during their first trimester of pregnancy. The study went on to find women taking Zofran during the first trimester of their pregnancy were 30% more likely to have a child with birth defects,3 including:
- Cleft lip
- Cleft palate
- Heart defects
- Musculoskeletal defects
- Kidney defects
- Fetal death
In June, 2012 the Food and Drug Administration issued an updated warning about a potential risk of issued an updated warning about the possible increased risk of prolongation of the QT interval, which can result in the potentially fatal arrhythmia.
If you took Zofran during your pregnancy to control nausea and vomiting and suffered an arrhythmia that required medical treatment or delivered a baby that was born with any of the above conditions, we would like to speak with you.
3 http://www.clinicalendocrinologynews.com/index.php?id=12242&type=98&tx_ttnews [tt_news]=221089&cHash=da03e20e36