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Many of the adverse events listed on the labels for statin drugs may not be supported by good evidence of a causal relationship, according to an analysis in The Lancet. Adverse events examined from 19 double-blind trials do not seem to show statin therapy causes cognitive impairment, depression, sleep disturbance, and peripheral neuropathy. Four events did have significance in the study. The authors say their analysis “has confirmed that statin therapy increases hepatic transaminase and other liver function tests in a statin intensity-related manner, although the absolute excess risks and clinical consequences appear to be low. However, no evidence of causality was found for the vast majority (62 of 66) of other outcomes listed as potential undesirable effects of treatment in statin labels.
”Now what? The authors suggest possible revisions to the drug labeling, and observers believe the perception of statin drugs’ safety has been skewed by the adverse effects listed on drug labels, which could deter prescribing practices. What’s more, some symptoms caused by unrecognized conditions could be misattributed to a patient’s use of statin drugs and create delays in proper diagnosis. Statins are widely prescribed in the United States. The number of individuals who reported taking any statin climbed from 31 million in 2008 to 92 million in 2018.