Bangalore: US health regulators said they are reviewing the safety of GlaxoSmithKline`s anti-nausea drug Zofran to ascertain whether there is a potential risk of abnormal heart rhythm.
The drug may increase the risk of developing abnormal changes in the electric activity of the heart, leading to a potentially fatal heart rhythm, the U.S. Food and Drug Administration said in a statement.
GSK will be required to conduct a study on whether Zofran could prolong a patient`s QT interval, a measure of heart rhythm. The results of the study are expected in summer of 2012.
In the meanwhile, the FDA said it was making interim changes to the drug`s labels to include a warning that Zofran be avoided in patients with congenital long QT syndrome.