Though tolerated well by the great majority of statin users, rhabdomyolysis has proven to be a very significant side effect. This condition is due to extreme muscle cell inflammation with rupture of the cell wall, spillage of cellular contents into the blood stream and secondary renal tubule obstruction.
Some feel this process is related to excess coenzyme Q10 inhibition fostering loss of cell wall integrity. Others show research findings suggesting that cholesterol insufficiency within the muscle cells leading to altered cell signaling is the dominant factor. Still others feel that unrecognized predisposing genetic factors are contributing.
Starting historically, from the period October 1997 to December 2000, 772 cases of statin associated rhabdomyolysis were reported to the FDA. Of this number 387 or 50% of these cases were associated with the use of Baycol, a relative newcomer at the time. During this same time period, 72 deaths resulted from rhabdomyolysis.
These observations prompted the consideration of withdrawing Baycol from the market. However, by the time action was finally taken, seven months later, in August 2001, Baycol was found to be associated with approximately 100 rhabdomyolysis deaths.
The withdrawal of Baycol by no means eliminated the statin associated rhabdomyolysis problem, for all statin drugs share this tendency, especially Zocor and Lipitor. Of the 772 hospitalizations during this time period, 24% were associated with the use of Zocor and 11% with the use of Lipitor. Although the concomitant use of fibrates has been a factor with many of the rhabdomyolysis cases, especially with Baycol, this effect is considered to be somewhat additive only without changing the statin drug tendency in this regard.
Further review of the FDA results reveal that of the total number of rhabdomyolysis cases reported in their database, 42.7% were found to be statin associated cases, representing a near sevenfold over-representation of statin use among the total cases, strongly supporting the causal role of these drugs. I recently found an article written by a medical doctor stating unequivocally that the statin effect on rhabdomyolysis was about the same as the normal, non-statin incidence. Nothing could be further from the truth.
The overall reported incidence of fatal rhabdomyolysis, excluding Baycol, was felt to be close to 0.15 deaths per one million prescriptions for the other statins commonly used. Following Baycol's withdrawal in 2001, this rate of fatal cases, associated primarily with the use of Zocor, Lipitor and Pravachol, continued unchanged until the arrival in 2003 of Crestor.
In October 2003, this powerful new statin drug was approved for marketing after a somewhat stormy approval period during which time its highest strength (80mg) pill was withdrawn because of the several cases of rhabdomyolysis seen and reported during the clinical phase of Crestor evaluation. Troubles were just beginning for this newcomer to the incredibly profitable statin market.
The FDA soon learned that Crestor had a unique renal toxicity problem independent of an obvious rhabdomyolysis problem from the very beginning. The new data comparisons showed that the rate of acute renal failure reports in people not having rhabdomyolysis was 75 times higher for Crestor than for the other statins combined.
In addition during the period from October 1, 2003 through September 30, 2004, it was found that the rate of reports of rhabdomyolysis sent to FDA was 6.2 times higher than the rate for all of the other statins combined. This is separate from the specific renal toxicity mentioned above.
This, readers, is the true, thoroughly documented, state of affairs today after numerous attempts by Public Citizens and other patient welfare groups to withdraw this drug as both toxic to kidneys and unnecessarily powerful for cardiovascular risk control unless restricted to very small doses.
Physicians must also understand that just behind Crestor in rhabdomyolysis potential is Zocor accounting for close to 25% of rhabdomyolysis deaths. Lipitor is just as powerful as Zocor but only half as likely to cause rhabdomyolysis.
Duane Graveline MD MPH
Former USAF Flight Surgeon
Former NASA Astronaut
Retired Family Doctor
Updated January 2016