Skip to content
My WebMD Sign In, Sign Up

Cholesterol & Triglycerides Health Center

Font Size

FDA Expert Examines Cholesterol Drug Safety

Most Statin Drugs Have Low Chance of Muscle Disorder
By
WebMD Health News

Nov. 22, 2004 -- Despite concerns about popular cholesterol-lowering "statin" drugs, a new study shows that most of these drugs have a low risk of a serious muscle disorder.

The study was released early in response to controversial statements from an FDA scientist last week. That scientist, David J. Graham, MD, MPH, is also the lead researcher of the new study.

Last Thursday, Graham spoke to Congress about drug safety and the problems with the arthritis drug Vioxx, which was removed from the shelves in October due to concerns it increases the risk of heart attacks and strokes. At that hearing, he also implicated five other drugs, as having safety concerns.

One of those drugs was the cholesterol-lowering drug Crestor, a member of the class of drugs called statins. Graham tells WebMD that the new study was started before Crestor became available in August 2003 and, therefore, he did not look at that statin drug.

Graham's study looked at the risk of a potentially serious muscle disorder called rhabdomyolysis among patients taking a statin drug -- either Baycol, Lipitor, Pravachol, or Zocor. Baycol was removed from the market in 2001 in the wake of reports that it had led to rhabdomyolysis and death in 31 people.

Rhabdomyolysis occurs when muscle tissue breaks down, releasing high levels of chemicals in the bloodstream that can cause kidney failure.

Statin Drug Risk "Similar and Low"

Graham's study included data based on more than 252,000 people treated with a statin drug or another cholesterol-lowering drug.

Graham found that nearly one out of every 23,000 people taking a statin drug alone developed rhabdomyolysis. The risk jumped tenfold in people taking Baycol, supporting the theory that this statin drug carried a much larger risk.

The researchers found that when a statin drug was combined with other cholesterol-lowering drugs called fibrates, such as Lopid and Tricor, about 60 of every 100,000 people developed rhabdomyolysis.

Graham says the risk of the muscle problem was "similar and low" for the statin drugs Lipitor, Pravachol, and Zocor. The study will appear in the Dec. 1 issue of The Journal of the American Medical Association.

However, Graham says the risk may be significantly higher in older patients with diabetes, where roughly one in 500 patients per year could develop muscle injury.

What About Crestor?

In June, the FDA advised doctors to be careful about how they prescribe Crestor.

The advisory followed label changes in Europe reflecting cautions for patients older than 65, those with underactive thyroids, and people with kidney problems, especially at the drug's highest dose, 40 milligrams. Those risks were already included on U.S. labels, according to news reports at the time.

Crestor's maker, AstraZeneca, released a statement in response to Graham's congressional hearing comments saying it is "fully confident in the safety profile of Crestor, which has now been approved in more than 65 countries worldwide.

"To date, the FDA has not given the company any indication of a major concern regarding Crestor, and the comments today are inconsistent with past public statements from the FDA and our understanding of its current view of the safety and efficacy of Crestor."

What Should Patients Do?

If patients develop muscle soreness, they should stop their medicine and call their doctor to be checked out for muscle injury, Graham tells WebMD. He says the typical patient in his study developed muscle soreness and pain about five to six days before being hospitalized with muscle injury.

Dark urine is another sign of possible muscle injury that should alert patients to call their doctor.

Is This Normal? Get the Facts Fast!

Is Your Cholesterol Level Heart Healthy?
What is your LDL (low-density lipoprotein) level?

Get the latest Cholesterol Management newsletter delivered to your inbox!


or
Answer:
Desirable
0-199
Borderline
200-239
High
240+

Your level is currently

Congratulations! Your total cholesterol level is in the Desirable range, and your level of "bad" LDL cholesterol is optimal.

Congratulations! Your total cholesterol level is in the Desirable range, and your level of "bad" LDL cholesterol is near optimal.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is borderline high. If your LDL goes higher, your total cholesterol level could become Borderline High. Consider reducing the amount of foods you eat with saturated fats and increasing physical activity. If you get more exercise, your level of "good" HDL cholesterol may increase, which could also help to keep your levels of LDL and total cholesterol in check.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is High. This may mean that your level of high-density lipoprotein (HDL), or "good" cholesterol, is too low. It is best to have a high level of "good" HDL and a low level of "bad" LDL. The HDL helps keep your LDL level in check. Ask your doctor for your HDL level. If your HDL is low, increasing your physical activity can increase it, which may help reduce your LDL level.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is Very High. This may mean that your level of high-density lipoprotein (HDL), or "good" cholesterol, is too low. It is best to have a high level of "good" HDL and a low level of "bad" LDL because the HDL helps keep your LDL level in check. Ask your doctor for your HDL level. If your HDL is low, increasing your physical activity can increase it, which may help reduce your LDL level.

Your total cholesterol level is Borderline High, but fortunately your level of "bad" LDL cholesterol is optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have other non-measured increases in LDL-like particles that can increase heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is Borderline High, but fortunately your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have other non-measured increases in LDL-like particles that can increase heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is Borderline High. Your level of "bad" LDL cholesterol is Borderline High, too. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is Borderline High. Your level of "bad" LDL cholesterol is High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is Borderline High. But your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol is High, but your level of "bad" LDL cholesterol is optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol is High, but your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is High. Your level of "bad" LDL cholesterol is Borderline High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is High. Your level of "bad" LDL cholesterol is High, too. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe medication, such as statins. Following medication, dietary, and exercise instructions should result in improvements.

Your total cholesterol level is High, and your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe statins or other cholesterol-lowering medications.

Start Over

Step:  of 

Today on WebMD

cholesterol lab test report
Article
Compressed heart
Article
 
Compressed heart
Article
chocolate glazed donut and avocado
SLIDESHOW
 
Heart Foods Slideshow
Slideshow
Cholesterol Fact or Fiction
Quiz
 
Food & Fitness Planner
TOOL
Attractive salad
ARTICLE
 
Heart Disease Overview Slideshow
SLIDESHOW
worst sandwich slideshow
SLIDESHOW
 
Fat Foods Fit Foods
SLIDESHOW
Bad Cholesterol
VIDEO
 

WebMD Special Sections