GSK anti-nausea drug may pose risk to heart rhythm: FDA
Sep 15, 2011, 1:56 p.m.
(Reuters) - U.S. 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 hearth 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.
(Reporting by Shravya Jain in Bangalore; Editing by Viraj Nair)
- BANGALORE (Reuters) - U.S. health regulators said they are reviewing the safety ...
- When shopping for the right walk-in tub company to handle your Arizona ...
- March 23, 2010, is a date that will live in infamy.
- One of the most interesting real estate concepts in recent years is ...
- The American Lung Association recently published the State of the Air Report, ...
- Last year, financial analysts observed a strange but encouraging phenomenon on opposite ...