The Drugs Controller General of India (DCGI) has directed the state drugs controllers to implement the safety label changes by the manufacturers marketing the cholesterol-lowering statin drugs in the country.

A decision to make this important safety label changes to cholesterol-lowering statin drugs was taken by the health ministry following a recommendation to this effect by the New Drugs Advisory Committee (NDAC) in its meeting held on April 21 this year. The NDAC after deliberations agreed the line of action as taken by US FDA. The NDAC expressed its opinion that in the light of the decision taken by the US FDA, India should also implement the safety changes as recommended for the statins.

The proposal was based on US FDA news release dated Feb. 28, 2012. These changes are made by US FDA to provide the public with more information for the safe and effective use of statins.

As per the new recommendations, the drug labels' have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. FDA now recommends that liver enzyme tests should be performed before starting statin therapy and as clinically indicated thereafter. FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect. Patients should notify their health care professional immediately if they have the following symptoms of liver problems: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-coloured urine; yellowing of the skin or the whites of the eyes.

Certain cognitive (brain-related) effects have been reported with statins use.  Statin labels will now include information about some patients experiencing memory loss and confusion. These reports generally have not been serious and the patients' symptoms were reversed by stopping the statin. However, patients should still alert their healthcare professional if these symptoms occur.

Increase in blood sugar levels (hyperglycemia) have been reported with statin use. The FDA is also aware of studies showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus. The labels will now warn healthcare professionals and patients of this potential risk.

Healthcare professionals should take note of the new recommendations in the lovastatin label. Some medicines may interact with lovastatin, increasing the risk for muscle injury (myopathy/rhabdomyolysis). For example, certain medicines should never be taken (are contraindicated) with (Iovastatin) including drugs used to treat H1V (protease inhibitors) and drugs used to treat certain bacterial and fungal infections.