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FDA removes warning of liver problems from statin labels

Category: Liver Diseases

Since statin medications first became a popular way for individuals to lower their cholesterol levels, the Food and Drug Administration has placed warnings on the labels of drugs advising patients to consider regular liver panel testing. However, the agency has now decided to remove this warning.

Statins have been linked in some patients to increases in potentially dangerous liver enzymes. These compounds have the potential to cause liver damage. However, the FDA now says that this problem is rare and too difficult to predict, even when an individual does undergo regular liver panel testing.

The agency issued a statement saying that it is removing the warning label because routine testing in does not appear to make a meaningful difference in the number of statin patients who develop liver problems. However, that does not mean there is no risk.

Warning labels on statins will still instruct physicians to conduct liver panel testing on patients before prescribing the drugs to ensure the individual is healthy enough. Furthermore, patients are advised to contact their healthcare provider if they start noticing symptoms of liver problems, which may include weakness, upper-belly pain or yellowing of the skin.
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