A new case study finds that Zofran may be fatal in children, especially those at an already increased risk of cardiovascular problems. This may add fuel to the fire surrounding the potential risk for Zofran heart defects in babies whose mothers took the anti-nausea drug during their first trimester of pregnancy.
The report was published on January 26th in the medical journal Pediatric Emergency Care, and found two heart-related deaths in children who took the medication. The research was led by doctors in Pennsylvania’s Lehigh Valley Health Network, who paid special attention to two cases.
The first involved a 10-year old who was exhibiting symptoms of gastroenteritis, also known as the common stomach flu. After taking two doses of Zofran, along with morphine, antibiotics, intravenous fluid and antibiotics, he became unresponsive and was showing signs of an elevated heart rate, a condition known as tachycardia.
The second case involved a child who was significantly younger, at just 86 days old. He was also given Zofran for symptoms of gastroenteritis, and also began experiencing supraventricular tachycardia. This resulted in ventricular fibrillation, before it was determined that the baby had undiagnosed congenital cardiomyopathy.
The children in both cases died as a result of these episodes, which could lend evidence to Zofran’s potentially harmful effects on the heart, kidneys, and other body parts of newborns and young children.
Zofran belongs to a class of medications that affect the central nervous system and are referred to as 5-HT3 antagonists. The medication was originally approved by the U.S. Food and Drug Administration (FDA) in 1991 as an anti-nausea treatment for chemotherapy and radiation patients, as well as those who underwent surgery. Over the years, however, it has often been prescribed to alleviate extreme nausea in women who may be experiencing extreme sickness during their first trimester of pregnancy, which is considered an off-label use not cleared by the federal agency. The drug’s manufacturer, GlaxoSmithKline, has been charged with paying doctors to promote the medication for pregnant women with extreme nausea by the U.S. federal government and a number of Zofran cases that have been filed. In 2012, the manufacturer paid $3 billion to resolve claims involving this medication and several others.
may be eligible to pursue a complaint against GlaxoSmithKline: .