June 29 GlaxoSmithKline has made changes
in the dosage label for its anti-nausea drug Zofran, U.S. health
The U.S. Food and Drug Administration on Friday said interim
data from a clinical study showed a 32 mg single dose of Zofran
could cause a potential risk of abnormal hearth rhythm.
The updated label removes the 32 mg single intravenous dose,
and says that the drug can continue to be used at the lower
recommended intravenous dose.
Glaxo conducted the safety study after regulators had voiced
concerns last September.
The FDA said in a statement it will evaluate the final study
data when available, and will work with Glaxo to explore an
alternative single-dose regimen.