Skip to content

Cholesterol & Triglycerides Health Center

FDA Rejects Bid to Ban Cholesterol Drug

Agency Says Crestor Is No Riskier Than Other Cholesterol-Lowering Drugs
Font Size
A
A
A
By
WebMD Health News

March 14, 2005 - Federal health regulators on Monday rejected a consumer group's call to ban the cholesterol-lowering statin drug Crestora consumer group's call to ban the cholesterol-lowering statin drug Crestor because of fears that it puts users at a high risk for muscle and kidney damage.

The FDA said it was rejecting a petition from drug industry watchdog Public Citizen because there was no evidence that Crestor was any more dangerous than other cholesterol-lowering statins already on the market.

The group filed a petition with the FDA in March of last year urging the agency to pull Crestor from the market because of a high rate of kidney failure and the muscle-damaging disease rhabdomyolysis associated with its use.

The group says 68 cases of rhabdomyolysis and 15 cases of kidney failure were reported to the agency and drug companies in the year ending October 2004. Some 5.2 million Crestor prescriptions were written in that time, though the majority of reports did not conclusively identify the drug as the cause of the reactions.

An FDA statement accompanying the rejection says the agency found no evidence in clinical trials or in postmarket safety monitoring that Crestor was more dangerous than other statin drugs, including Lipitor and Zocor.

"Our review of all of the available evidence ... indicates that Crestor does not pose a risk of muscle toxicity greater than that of other approved statins," an agency statement reads.

Crestor manufacturer, AstraZeneca, last week revised the drug's label,AstraZeneca, last week revised the drug's label, urging doctors to use the low 5-milligram dose of the drug in some patients at higher risk for complications. Such patients included Asians, those taking immune-suppressant drugs like cyclosporine, and those with kidney disease.

The company also said doctors should reserve the drug's highest dose, 40 milligrams, for patients who do not achieve sufficient cholesterol lowering at lower doses.

"This should reassure the millions of people who have been unnecessarily alarmed by Public Citizen," says AstraZeneca spokeswoman Rachel Bloom-Baglin.

Sidney Wolfe, MD, director of Public Citizen's Health Research Group, says the FDA's refusal to order Crestor off the market had a "familiar ring" to its action with Vioxx and other drugs, where it refused to act on early safety warnings.

"Once again, when faced with concerns about the safety of a drug, the FDA has sided with the drug company," he says in a news release.

"This response should give no comfort to either physicians or patients who are using or considering using Crestor," Wolfe says.

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

woman pulling supplements from shelf
Can they help lower yours?
bowl of yogurt with heart shape
What it can do for you.
 
woman exercising
14 practical tips.
chocolate glazed donut and avocado
What your levels mean.
 
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