If you are pregnant and suffering from morning sickness DO NOT TAKE ZOFRAN.
The anti-nausea drug causes heart defects, cleft palate, cleft lip and possibly other birth defects.
Women who took Zofran (ondansetron) in the early stages of pregnancy need to understand that this drug was never approved by the FDA for use during pregnancy. It had only been approved by the FDA for post-operative nausea and nausea in cancer patients. Zofran passes through the placenta membrane to the fetus. Despite this fact, Zofran has been marketed by Big Pharma for off label use in the treatment of morning sickness during pregnancy.
The manufacturer of the drug, Glaxo Smith Kline, pled guilty to federal criminal/civil charges in 2012 and paid billions in fines for promoting Zofran (and several other drugs) for non-FDA approved use (e.g. morning sickness) and for paying kickbacks to doctors to prescribe these drugs.
Zofran can alleviate nausea because it essentially blocks chemicals in the brain such as Serotonin that cause vomiting. Recent medical studies, including a 2013 Denmark study involving 900 women suggests that there is about a twofold increase in heart defects when women take Zofran early on in their pregnancy. A separate study from the Center for Birth Defects Research and Prevention concluded that there was a significant increased risk for cleft palate when Zofran is taken during the first trimester of pregnancy. There are hundreds of Adverse Even Reports on file with the FDA related to birth defects and Zofran.
If you or your family member was prescribed Zofran during pregnancy, and your child has birth defects, contact us for a free consultation. A personal injury lawyer Silver Spring, MD can be reached at (888) 213-8140. If we take your case, there is no attorney fee if there is no recovery.