'Very Low' Risk From Statin Cholesterol Drugs
Study Says Kidney and Muscle Damage Seen Mostly in People Vulnerable to Those Problems
Conditions That Carry Higher Risk of Muscle Damage
The following conditions are listed as carrying a higher risk of muscle damage from statin drugs, which require either avoidance of the drugs or use of a lower dose:
- Older age, especially greater than 80 (women more than men)
- Small frame and frailty
- Multiple chronic medical conditions, such as chronic kidney failure (especially with diabetes)
- Use of multiple medications that may change the metabolism of the statin drug, especially antifungal drugs
- People who drink large amounts of grapefruit juice (more than one quart per day), which alters the metabolism of statin drugs
- Alcohol abuse
Because each person is different, doctors and patients should know and discuss the risks and benefits before choosing a statin, Grundy told reporters. Cholesterol-lowering statin drugs include information about possible rare muscle or kidney problems in their prescription information; the possible risk isn't a new discovery.
Karas and colleagues looked at muscle and kidney problems reported to the FDA during Crestor's first year on the market (starting in the latter half of 2003).
During that time, there were 28 such side effects per million Crestor prescriptions, 13 per million Zocor prescriptions, 3.5 per million Pravachol prescriptions, and 4.3 per million Lipitor prescriptions, says Karas.
Deaths were extremely rare for all of the statins.
Because reported side effects might be different during a drug's first year, they also checked reports for the three older drugs -- Pravachol, Lipitor, and Zocor -- in their first year of release. Crestor's number was higher than those drugs during their first year but lower than that of another statin, Baycol, which was pulled form the market in 2001.
Baycol was taken off the market because of concerns about deaths related to rhabdomyolysis.
FDA and Crestor
In March, the FDA issued a public health advisory about Crestor's potential risks and benefits. That followed a January 2005 report by AstraZeneca that a patient died while taking Crestor.
After an extensive review, the FDA said that patients taking recommended doses of Crestor had a similar risk of rhabdomyolysis as other statin drugs. Grundy praised the FDA's review in his editorial.
In March, an AstraZeneca news release said the FDA's letter stated that "all of the available evidence indicates that Crestor does not pose a risk of muscle toxicity greater than the other approved statins, and that with respect to renal toxicity, there is no convincing evidence that Crestor poses a serious risk of renal injury.
"Recently, the FDA approved revisions to the Crestor prescribing information, which strengthened language around the appropriate use of Crestor," the release continues. "At the same time, the FDA issued a statement confirming that the potential benefits of Crestor outweigh the potential risks when taken as directed."