17 August 2012, USA, California( Xmaspharmacy.com): The FDA (Food and Drug Administration) has reported GlaxoSmithKline (GSK) pharmaceutical company to make some changes to the labels of its drug Zofran, by adding the results of the risk of arrhythmia safety study.
Zofran is a drug product of the GSK pharma company that has been approved for use in chemotherapy to relieve the patients from nausea and vomiting.
As per the results obtained from the clinical study conducted by the FDA, it has been found that a 32 mg dose of the drug Zofran given by intravenous route of administration may cause interference in the heart’s electrical activity. This prolongation of the QT interval may predispose the individual to acquire an abnormal and a fatal heart rhythm complication that is commonly known as Torsades de Pointes.
According to the notice issued in this regard, the company is supposed to update the label of its drug Zofran by removing the recommended single IV dose of 32 mg. Whereas, no changes are recommended for the other lower intravenous doses of 0.15 mg per kg body weight that is prescribed to be taken every 4 hours as three doses and no single IV dose should exceed the 16 mg level.
Currently, no changes have been reported pertaining to the instructions of oral doses and the approved usual recommended oral dose of Zofran ranges to the maximum limit of 24 mg. The medication Zofran has been approved long before and is in use for quite some time.
The drug regulatory agency has previously issued a warning to the GSK back in September, to check the dangerous and fatal complications of heart rhythm changes, which caused the change of label to include a precautionary warning to avoid its use in congenital long QT syndrome patients.
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