Anti-Nausea Drug prescribed to treat side effects of chemotherapy and hyperemesis gravidarum a serious form morning sickness in pregnant women, or stomach issues in children.
History – GlaxoSmithKline’s Zofran received FDA approval in 1991. The FDA released a safety warning in 2011 for QT prolongation. QT prolongation is an electrical disturbance in the heart. This disturbance causes a chaotic heart rhythm. In 2013 the FDA issued a warning against using Zofran and generics of Zofran during pregnancy. This warning stemmed from a clinical study associating congenital cardiac malformation and oral clefts with Zofran use.
The first Zofran lawsuit was filed in 2015 by a Minnesota mother. Currently there are more than 500 actions in federal court against GlaxoSmithKline. The claims state the company failed to warn the public about the risks and hid evidence associated with the use of Zofran during pregnancy. GlaxoSmithKline marketed Zofran for the use of morning sickness without FDA approval.
Related Drugs: Zuplenz
Mild Side Effects: Chills, Constipation, Drowsiness, Headache, Tiredness
Serious Side Effects: Abnormal heart rhythms, Blurred vision, Chest pain, Coma, Confusion, Electrolyte imbalance, Hives/Rash, Loss of consciousness, Neuromuscular changes, delivery, Seizures, Serotonin syndrome, Shortness of breath, Swelling
Serious Birth Defects: Kidney malformation, Musculoskeletal anomalies, Mouth deformities, Jaundice, Heart defects, Still birth
Manufacturer: Novartis Pharmaceuticals Corporation