In a major safety announcement for some of the most widely prescribed drugs in the world, the FDA has announced sweeping label changes for statin medicines for cholesterol. The full release can be found at www.fda.gov.
Importantly, requirements for testing liver function have been revised to say that periodic monitoring of liver enzymes is no longer needed. What is now recommended is testing of liver enzymes (baseline) BEFORE treatment is started, then as clinically needed thereafter. This was based on FDA findings that liver effects were rare and that the testing did not appear effective.Patients are still encouraged to call their doctor immediately if they have unusual weakness or fatigue, upper belly pain, dark colored urine, yellowing of the skin or eyes or other signs of liver problems.
The FDA also noted that increases in blood sugar (hyperglycemia) have been reported. The drug labels will now warn professionals and consumers about this newer risk (although the benefits of the drugs outweigh the risks of this problem).
Some memory loss and confusion (usually mild and reversable if the drug is stopped) have been seen with statins. The new labels will reflect this information and the FDA encourages patients to call their doctors if these symptoms happen.
Lastly, the FDA has broadened the labeling for drug interactions and lovastatin. Crucial ones include some HIV treatments (protease inhibitors) and some drugs or bacterial and fungal infections. The current Essential Guide to Prescription Drugs, a new look at cholesterol on Amazon (www.amazon.com/dp/B005LPSUOM ) has many of these elements already and will be updated to reflect the new FDA label changes.