What is Zofran®?
Zofran is approved by the Food and Drug Administration (FDA) to prevent nausea and vomiting caused by chemotherapy and radiation therapy. It is also used to prevent morning sickness during pregnancy as an off-label use. An off label use is when the drug is approved for the treatment of a condition through the FDA, but through clinical trials, the company deems the drug safe for other uses. Between 2002 and 2004, Zofran manufacturer GlaxoSmithKline began promoting Zofran as an off-label treatment for morning sickness despite the fact that the drug was never approved for this use and that there had been no real studies on the side effects in pregnant woemn. In 2012, the U.S. Department of Justice accused GlaxoSmithKline of marketing Zofran and other drugs for off-label uses. The drug company agreed to pay $3 billion to the U.S. government.
Zofran Birth Defects
In 2012, a study conducted at the Sloan Epidemiology Center involving more than 9,000 pregnant women, found that women who were treated with Zofran during their first trimester had twice the risk of deliver a baby with a cleft palate. A second study conducted by researchers in Denmark involving more than 900,000 births from 1997 to 2010 found that pregnant women treated with Zofran during the first trimester were twice as likely to give birth to a baby with a serious congenital heart condition.
In November 2013, the journal BioMed Research International published a study during which Australian researchers found a 20 percent increase in major birth defects for babies when the mother took Zofran during the first trimester.
Zofran Lawsuit Lawyer
If your child has been born with a cleft palate or heart issues as a result of the mother’s potential use of Zofran, please call the Mobile Alabama Zofran Lawyers at Moore Law Firm today for a free consultation. 251-445-7602.