Recently the FDA enhanced its required labeling on statin drugs to include a warning the there might be a link between the use of statins and some forms of reversible cognitive impairment. But last week, in an article in the Annals of Internal Medicine, Dr. Karl Richardson and colleagues from the University of Pennsylvania and Stanford University presented a study that cast doubt on the validity of the FDA s warning.
In a systematic review of previous studies, the researchers noted a dearth of well-controlled, randomized studies of statins and cognitive impairment. In addition, an examination of the FDA s own postmarketing surveillance databases revealed a low reporting rate for cognitive-related adverse events with statins.
They concluded that while better studies are needed to draw strong conclusions about any link between statin use and cognitive impairments, Published data do not suggest an adverse effect of statins on cognition.
ACSH s Dr. Gilbert Ross had this opinion: People should not be scared away from taking prescribed statins to lower cholesterol levels and thus lower the risk of cardiovascular disease, in spite of the FDA s statement. The value of this class of drugs has been proven time and time again, and any fears of impaired cognition are still just theoretical. It s too bad the FDA chose this beneficial class of drugs to get all alarmist about, without due cause, and we should be thankful to Dr. Richardson and his group for setting the record straight. I hope the FDA issues a retraction.