GlaxoSmithKline faces a slew of lawsuits after women taking Zofran gave birth to children with heart defects. Victims allege the pharmaceutical company’s anti-nausea medication Zofran may have caused their children’s medical conditions. Women who took Zofran while pregnant report fetal side effects such as heart and kidney conditions, low birth weight, and even infant death. The lawsuits claim that GlaxoSmithKline illegally marketed the medication to pregnant women, despite knowing of links between pregnant women taking Zofran and their children developing serious cardiac defects.
In January 2012, the medical journal “Birth Defects Research” published a study linking the use of Zofran during the first trimester of pregnancy with a 2.37-fold higher risk of developing a cleft palate.
Zofran-linked pregnancy risks and side effects
Zofran is approved to treat chemotherapy-associated nausea and vomiting, but is routinely prescribed for off-label use to treat morning sickness in pregnant women. Zofran works to treat nausea and vomiting by affecting the brain’s serotonin levels. While doctors are allowed to prescribe Zofran for the treatment of off-label conditions, it is illegal for drug manufacturers to market their products for uses other than those approved by the Food and Drug Administration (FDA).
In 2012, GlaxoSmithKline agreed to a $1 billion settlement with the federal government over claims it illegally marketed Zofran as a treatment for morning sickness in pregnant women. GlaxoSmithKline’s Zofran settlement with federal authorities was part of a much larger $3 billion settlement it reached for illegally promoting one other drug and concealing safety information of a diabetes study from the FDA.
In recent years, Zofran maker GlaxoSmithKline has come under increased scrutiny as revelations emerged the world’s sixth-largest drug manufacturer was bribing doctors to prescribe its medications. GlaxoSmithKline was found guilty by Chinese authorities 2014 and fined almost $500 million for bribing doctors to prescribe its drugs. Several doctors and a regional manager for GlaxoSmithKline have also been charged in Poland for taking part in a similar bribery scandal.