Important Safety Label Changes To Cholesterol-Lowering Statin Drug
Summary: Labelling compliance is an important part of the drug licence application process in India. To ensure the safety of people using statins in India, all manufacturers of drugs and people involved in drug imports in India must comply with the rules and regulations set by the authorities.
The New Drugs Advisory Committee in a meeting held in the year 2012 proposed to impose some vital safety label changes for labelling of some widely used cholesterol-lowering drugs. The proposal was based on USFDA new releases where the changes were made to make the public more alert about the safe and efficient use of statins.
These proposed changes were drafted based upon a news release released by USFDA(United States Food and Drug Administration). FDA made changes to the existing policy for statins so that consumers of such drugs should be well aware of the side effects caused by the drug and all possible drug interactions.
But first, let’s understand what statin is. It is a class of prescription drugs that are consumed along with proper diet and exercise for decreasing the level of LDL cholesterol. Also known as ‘bad cholesterol’ in layman terms.
All the labelling alterations made were to offer the public with all necessary information and warnings about the safe use of statins.
Some of the potential side effects of consuming statins are memory loss, confusion, and enhanced blood sugar along with increased haemoglobin levels. The risk of muscle injury also increases when a statin is used with other cholesterol-lowering drugs like fibrates, a big dose of niacin, ranexa which is a medicine used for the treatment of angina and colchicines, which is a medicine used for treating gout.
USFDA has also determined the levels of liver injury that occurs with the prolonged use of statins. All labels have been revised to eliminate the requirement of routine monitoring of liver enzymes. Patients are advised to refer their healthcare professional for any questions and should also report about the side effects.
After a few deliberations, NDAC(New Drug Advisory Committee) also agreed to this line of action taken by FDA and urged that India should also implement such rules. Hence all the state licensing authorities in the country were to request all manufacturers of the cholesterol-lowering station to comply with and execute these safety label changes.