In August 2001 the statin drug, Baycol, was removed from the market after causing at least 60 deaths. As a result, the safety of all statin drugs has subsequently come into question. While the Food and Drug Administration (FDA) maintains that statins in common use cause considerably fewer adverse side effects than Baycol, the agency acknowledges that their use does pose some risk.
All statins increase a patient's chances of developing myositis and rhabdomyolysis, potentially fatal conditions that cause muscle pain and muscle deterioration and may lead to kidney failure. According to the FDA, the chances of developing myositis or rhabdomyolysis from statins are low. As such, they remain on the market.It should be noted that with the exception of Baycol, most doctors believe that the benefits of statin therapy far outweigh the risks associated with this class of drugs. No small part of this belief is based on ignorance, for deaths and disability from rhabdomyolysis is often not effectively communicated to the busy practicing physician.
Until recently my own access to this kind of information was derived primarily from my hundreds of reports from disgruntled statin users. Even some of my astronaut friends have been ravaged by statins with disabling aches and pains, persisting years after the offending statin was discontinued. Many of the letters I receive report this kind of problem, muscle pain appearing shortly after starting their statin that appears to be permanent in that it does not go away even after years.
Reports of rhabdomyolysis have been sparse but I put that in the category of "dead men tell no tales" for deaths are rarely reported to me. The letters I have received have been mostly narrow escapes from rhabdomyolysis of the type publicized in Smart Money magazine of the unfortunate husband of Sharon Hope, who only now is becoming somewhat functional but not at all like he was in his former CEO capacity.
Since so many of these cases were associated with the use of Lipitor I had come to think of Lipitor as a primary cause of this problem. I have since learned that this is not so for FDA records reveal the surprising truth that all of the powerful statins share the potential for severe muscle damage, occasionally with kidney failure and death.
A review of FDA records on statin use up to the year 2000 revealed that a surprising 81 rhabdomyolysis deaths and over 385 hospitalizations for rhabdomyolysis were caused by a statin other than Baycol (cerivastatin). Of these 81 deaths, 13 were due to Lipitor (atorvastatin), 27 were due to Mevacor (lovastatin) 10 were due to Pravachol (pravastatin) and 30 deaths were due to Zocor (simvastatin).These rather astonishing figures were those up to the year 2000. Since that time promotion and sales of all statins have sky-rocketed, higher and higher dosage levels are in vogue and the super-powerful statin, Crestor, has been added. When the FDA finally sees fit to release current figures for rhabdomyolysis deaths and hospitalizations, I should not be surprised to learn that the pre 2000 figures will be quadrupled.
All this to lower one's cholesterol in a research environment that increasingly is telling us of cholesterol's irrelevancy in the atherosclerotic process. We now increasingly think that inflammation is the culprit. Why then this misguided focus on cholesterol? Yes, statin drugs are powerful anti-inflammatory agents. That appears to be their mechanism of action in cardiovascular risk reduction. It makes sense to me that dosing of these powerful drugs should be based on inflammatory markers not cholesterol levels.
Duane Graveline MD MPH
Former USAF Flight Surgeon
Former NASA Astronaut
Retired Family Doctor