The Food and Drug Administration (FDA) in the US is responsible for making decisions about which drugs should be licensed. It also keeps a database of information regarding the adverse effects of drugs, and occasionally revises the warnings issued with prescription medication. On the 28th of February, the FDA issued new guidelines regarding the management of individuals taking statins. You can read these guidelines here.
One of the potential adverse effects of statins is liver damage (statins actually work in the liver to impair cholesterol production there). Some doctors would therefore routinely monitor liver function in people on statins with blood tests. The FDA maintains that “serious liver injury” is “rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing serious liver injury.”
The FDA remains aware, of course, that liver damage is a possibility, advising that: “There have been rare reports of serious liver problems in patients taking statins. Patients should notify their healthcare professional right away if they have the following symptoms: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-coloured urine; or yellowing of the skin or the whites of the eyes.”
The FDA guidelines also highlight the fact that statins can, in some, induce mental problems such as memory loss and confusion. Here’s what they have to say about this: “There have been rare post-marketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These reported symptoms are generally not serious and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).”
The fact that such symptoms can take a long time to come on is a concern, because many doctors will not suspect that statins may be causing a symptom that develops years after a drug is commenced. There’s a good chance, therefore, that many problems genuinely induced by statins will go undetected. In other words, such mental problems may not be as “rare” as the FDA and many medical practitioners think.
The FDA, in its new guidelines, also draws our attention to the evidence which links statin use with impaired blood sugar control. The new guidelines warn doctors and patients alike about this. It adds, though, that: “[the] FDA continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.”
Just to remind ourselves, many individuals need to take statins for several years for one to avoid having a heart attack. What this means, is that the vast majority of people who take statins will not benefit from them at all. Also, the majority of people who take statins are essentially healthy (no history of, say, heart disease or stroke). In these people, statins do not reduce overall risk of death over time. What this means is that for the great majority of people, taking statins will not extend their life by a single day.
The new guidelines issued by the FDA only serve, I think, to remind us that the risk/benefit ratio of statins is not so stacked in favour of ‘benefit’ as we have been led to believe.
Here’s to a healthy heart
Dr John Briffa
for The Cholesterol Truth
Bear in mind we are not addressing anyone’s personal situation and you should rely on this for informational purposes only. Please consult with your own physician before acting on any recommendations contained herein.
Category: Statin Drugs Side Effects