FDA statin changes
February 29, 2012
THE US Food and Drug
Administration has today
announced labelling changes for a
range of statins including
atorvastatin, fluvasatin, lovastatin,
pitavastatin, pravastatin,
rosuvastatin and simvastatin.
The labels have been revised to
remove the need for routine
periodic monitoring of liver
enzymes in patients taking statins.
The FDA is now recommending
that liver enzyme tests should be
performed before starting statin
therapy, and “as clinically indicated
thereafter”.
The agency says it’s concluded
that serious liver injury with statins
is unpredictable, and routine
periodic monitoring is not effective
in detecting or preventing the “rare
side effect”.
Statin labels will also now include
information about some patients
experiencing memory loss as well
as increases in blood sugar levels.
Changes to the lovastatin label
also warn about some interactions
and contraindications.
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