The Great Danish Registry Debate Over Zofran

Published on May 5, 2015 by

In the February 2014 issue of the journal Therapeutic Drug Monitoring, Dr. Gideon Koren, director of a patient’s advocacy group called Motherisk, discussed a hotly contested analysis of the Zofran birth injury issue. In his piece, “Scary Science: Ondansetron Safety in Pregnancy—Two Opposing Results From the Same Danish Registry” he took a look at data collected on over 2,000 pregnant women. Some researchers examined these data and published a piece in the New England Journal of Medicine in February 2013, saying that they couldn’t find an association between Zofran use and birth injuries.

Critics, however, took issue with the fact that researchers began looking for evidence of birth injuries 10+ weeks after the fetus started developing – beyond the window when such defects typically appear. Other researchers looked at similar data and said that they found a dramatic 2.4 increase in the incidence of cleft palate among children as well as the following:

“[We found] a 2-fold increased risk of cardiac malformations with ondansetron (Zofran), leading to an overall 30 percent increased risk of major congenital malformations.”

Assessing the complex situation, Dr. Koren had this to say:

While perceived safe in pregnancy, several recent studies raise concerns about both fetal and maternal safety of ondansetron. Until more data are available, it should not be a first-line medication for morning sickness.”

In a separate article, he went on to say: (bold is ours)

[Here is a drug not meant for pregnancy, given in pregnancy, with no data. So how do you know it’s safe for a baby?] It’s an extrapolation that doctors do… They think it’s the last chance for your patient. They think that there’s an edge for that drug compared to other drugs.”

In our next post we will discuss how Zofran effects not only the baby but the mother as well.

To explore the possibility of bringing legal action right away to obtain compensation for Zofran-related birth defects please call the experienced attorneys here at Marc Whitehead & Associates, LLP at (855)-423-3666.

For more information regarding Zofran please download a copy of our free E-book, The Zofran Tragedy.