'Very Low' Risk From Statin Cholesterol Drugs
Study Says Kidney and Muscle Damage Seen Mostly in People Vulnerable to Those Problems
Screening Recommended Before Prescription
Most of the muscle and kidney side effects occurred in people who were particularly vulnerable to those problems and generally went away when the medications were stopped, said Grundy. He encourages doctors to screen for risk factors before prescribing any statin.
Patients should also talk to their doctors about any issues that come up, such as brown urine, an indication that muscle damage or liver problems may be occurring. Also, "very dramatic [muscle pain] that doesn't go away" is something Karas recommends that patients should discuss with their doctors. Those may be symptoms of a severe and potentially fatal condition called rhabdomyolysis, in which massive muscle damage occurs.
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.