UPDATE 1-GSK updates nausea drug label on safety concerns - FDA
June 29 |
June 29 (Reuters) - GlaxoSmithKline has made changes in the dosage label for its anti-nausea drug Zofran, U.S. health regulators said.
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.
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