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Saturday, March 3, 2012

US FDA approves new changes for labeling of cholesterol lowering drugs of statin group.


New saftey labeling requirements for class of drug statin:

Cholesterol is very important constituent of human body, it is used by our body for building tissue and for synthesis of various hormones and vitamins like vitamin D which helps in regulating calcium in bone, cholesterol is also used by our body in synthesis of bile acid which help in digestion of fat and oily food.

However higher blood cholesterol level increases risk of heart disease and stroke, therefore blood cholesterol lowering drugs are used to treat higher cholesterol level to reduce the risk of coronary heart disease and stroke.

Statin group of drugs have very important role in managing hypercholesterolemia, and have proved life saving drugs over the period of time. There are some serious side effects associated with statin group of drugs as well, therefore to improve on saftey aspects associated with use of cholesterol lowering drug of class statin, US FDA has introduced new labeling changes.

US FDA has approved new labeling requirement for these group of drugs which are as follows.

1.) No need of routine monitoring of liver enzyme for patients taking statin group of drugs.
Earlier it was required that patients taking statin drugs should be monitored for signs of liver damage , to identify that , changes in liver enzyme were required to be monitored , it is not required now as serious liver injuries with use of statin group of drugs are rare.How ever patient should inform if doctor if they have increased level of fatigue , yellow urine, and skin terning yellowish.

2) Addition of information about Adverse Reaction, it requires now label should have information on non serious adverse events like, increased blood sugar level and glycosylated hemoglobin (HbA1c) and feeling of loss of memory and confusion which are reversible and cease with discontinuation of therapy, since protection offered by these drugs over coronary and cardiovascular disease and stroke is of greater value patients should not discontinue drug unless asked by physician.

However new label will now have to provide information about increase in fasting plasma glucose and increases in HbA1c associated with statin drugs.


3) Drug interactions :
Statin class of drug do pose risk of developing muscle injury and rhabdomylosis, in certain statin drugs and the risk of  muscle injury and rhabdomylosis is increased when combined with other drugs therefore to provide additional saftey information about use cholesterol loweriung drug of statin  US FDA has published following table of drugs with which statins should not be combined. Therefore statin group of drugs will now have to provide information about newly added contraindications along with some of earlier listed drugs when it should not be combined with other drugs which increase risk of muscle injury.

Earlier in 2010 US FDA had issued a saftey alert about drug simvastatin  which may cause muscle injury rhbdomylosis, kideny failuer in patients taking simvastatin in higher dose more than 80 mg. 


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