Statin drugs : update

Changes for statin drugs ( cholesterol lowering drug)

In late February 2012, the U.S.Food and Drug Administration (FDA) approved safety label changes for statin drugs. In summary,  the FDA changes are as follows:

1. Monitoring Liver Enzymes

Removal of the need for periodic monitoring of liver enzymes. Liver enzyme tests should now be performed before commencing statins and as clinically indicated thereafter, due to the rare and unpredictable nature of serious liver injury with statins.

 

2 Adverse Event Information

Addition of information about the potential for :

 

A)Cognitive adverse events

The FDA report suggests that rare post-marketing reports of cognitive impairment have been made, including reports of memory loss, forgetfulness, amnesia and confusion, associated with statin use. These are generally non-serious and reversible

 

**I have heard of the memory loss experience from a customer .**

 

B) Increases in glycosylated haemoglobin (HbA1c) and fasting plasma glucose

 

 

 

 

 

The Australian Therapeutics Goods Administration (TGA) is currently reviewing the evidence for these safety-related changes and will update the Product Information for these medicines where necessary.

 

 

Reference: RGH Pharmacy E-Bulletin Volume 45 (12): April 16, 2012