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March 2, 2005 04:44

The evidence is very, very strong," said Dr. Steven Nissen, vice chairman of cardiology at the Cleveland Clinic and lead investigator of the second study. Both analyses found that CRP points to elevated inflammation in the arteries and that cholesterol-lowering statin drugs can diminish levels of the protein.

The two research projects have paved the way for potentially hundreds of thousands of new patients to take cholesterol-lowering medications such as Lipitor, Crestor, Mevacor, Zocor and Pravachol.

Q: I am 69 years old and have always been physically fit. I was a marathon runner from age 40 to 55. Now I run for fitness.

I was dismayed to learn that I have high cholesterol despite my exercise. My doctor prescribed Lipitor and I have taken it for two years. I am experiencing leg pains for the first time in my life. I've also noticed some alarming memory gaps and loss of feeling in my right hand fingertips. Could any of these symptoms be side effects of Lipitor?

A: Cholesterol lowering drugs like Crestor, Lescol, Lipitor, Pravachol and Zocor save lives by reducing the risk of heart attacks and strokes. But as effective as such statins are at lowering cholesterol and inflammation they can have side effects.

Some people have reported muscle or joint pain, cognitive problems and peripheral neuropathy (nerve damage signaled by burning, tingling or loss of sensation). Such symptoms are not always recognized as reactions to statins.

http://www.tristateneighbor.com/articles/2005/03/01/tri_state_news/country_living/news9.txt

According to Astra Zeneca, in the STELLAR Study, one of the largest head-to-head studies of its kind, the usual starting dose of CRESTOR lowered bad cholesterol more effectively than the most common doses of the other leading medications1,2. This study was a major medical trial comparing cholesterol medications taken with a healthy diet.

http://www.crestorfacts.com/questions.aspx

In the STELLAR study, the usual starting dose of CRESTOR was more effective at lowering bad cholesterol than the most common doses of the other leading medications.* This study was a major medical trial comparing cholesterol medications taken with healthy diet. See: http://www.crestor.com/

What Crestor Side Effects should you know about?
According to its manufacturer, "like all medicines, CRESTOR? (rosuvastatin calcium) may cause side effects in some people. These side effects are usually mild to moderate and usually go away after a short time. The most common side effects are muscle pain, constipation, weakness, stomach pain, and nausea. For a complete list of side effects, see the full Prescribing Information for CRESTOR."

If you develop any unexplained muscle pain, tenderness, or weakness at any time during treatment with CRESTOR (especially if you also have a fever or feel ill), call your doctor right away.

For further information from AstraZeneca, see: http://www.crestor.com/c/crestor/sideeffects.asp

Washington Post - USA The popular new cholesterol-lowering drug Crestor may cause an increased risk of potentially life-threatening muscle damage, especially in people of Asian ... <http://www.washingtonpost.com/wp-dyn/articles/A2787-2005Mar2.html>

- USA TOKYO (MarketWatch) - The US Food and Drug Administration said popular cholesterol-lowering drug Crestor may cause an increased risk of muscle damage in people ... <http://cbs.marketwatch.com/news/story.asp?guid=%7B7AE710AF-BD2F-4305-A54F-C08EC90EBD23%7D&siteid=google&dist=google>

MSN Money - USA LONDON (Reuters) - Leading brokers slashed sales forecasts for AstraZeneca Plc's cholesterol drug Crestor on Friday, lopping more than 1.5 percent off shares ... <http://moneycentral.msn.com/inc/news/breakingredir.asp?feed=OBR&Date=20050225&ID=4266344>

The News Journal - Wilmington,DE,USA A leading broker cut its sales estimates for AstraZeneca's anti-cholesterol drug Crestor on Friday after a survey it sponsored found that many doctors are ...

USA ... AstraZeneca Plc may gain after the US Food and Drug Administration said the drugmaker's cholesterol treatment Crestor has a risk similar to competitors. ... <http://www.bloomberg.com/apps/news?pid=10000100&sid=abkuxsE2TQo8&refer=germany>

FDA: A Warning was issued on use of crestor by Asians. The cholesterol drug Crestor is being relabeled to add a caution that starter doses should be reduced in Asian-Americans and some other patients. The FDA issued Crestor warnings to the public Wednesday about risks of muscle damage from AstraZeneca Plc's cholesterol-lowering drug Crestor but said the risks were like those of similar drugs in the family called statins. The Food and Drug Administration warned the public Wednesday about the chances of muscle damage from AstraZeneca Plc.'s cholesterol-lowering drug Crestor but said the risks were like those of similar drugs.The drug maker AstraZeneca PLC reported Wednesday that the Food and Drug Administration approved revised labeling for its cholesterol-lowering statin Crestor based on 15 months of postmarket data.

Thus, there is no Black Box for Crestor. Labeling Revisions for CRESTOR(R) were approved by the FDA. AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) approved revisions to the prescribing information for its cholesterol-lowering medication, CRESTOR(R) (rosuvastatin calcium), based on submissions made by AstraZeneca. The FDA provided this updated patient and healthcare Provider Information Concerning Crestor. In order to provide Americans with earlier access to emerging safety information about their medicines, the Food and Drug Administration (FDA) today issued a public health advisory, a patient information sheet and a corresponding healthcare professional information sheet further explaining the identified risks and benefits of Crestor (Rosuvastatin calcium), a cholesterol-lowering drug.

When was Crestor approved?
Crestor (rosuvastatin calcium) received final approval for use in the United States in August, 2003.

What class of medication is Crestor?
Crestor is a member of a family of drugs known as "Statins". Other members of the statin family include: Lipitor, Zocor, Pravachol, Lovastatin, Advicor.

What does Crestor do?
Crestor reduces your cholesterol by blocking the liver from manufacturing cholesterol. In humans, the liver creates cholesterol at night while you are sleeping. For this reason, Crestor (as well as all of the other statins) should be taken at night.

Who makes Crestor?
Crestor is marketed by the AstraZeneca Corporation (a large British pharmaceutical company).

How does Crestor work?
Crestor works on lowering cholesterol by acting on the liver. The liver produces enzymes. Crestor inhibits an enzyme that is present in the liver which is necessary to manufacture the bad cholesterol (LDL).

What Crestor dosages are safe?
The ordinary starting dose of Crestor is 10mg per day. The maximum dose of Crestor is 40 mg per day. Dosages above this have been shown to cause rhabdomyolysis.

What side effects does Crestor cause?
Some people have stated that Crestor causes dangerous side effects such as proteinuria (protein in the urine) and rhabdomyolysis, (a dangerous condition where the muscles break down and release toxic chemicals into the bloodstream that hurt the kidneys).

What Are Some Possible Side Effects of Crestor?
The more common side effects of Crestor are usually mild and may go away:

• Nausea
• Headache
• Constipation
• Diarrhea
• Gas
• Upset stomach and stomach pain
• Rash
• Muscle and joint pain

• Muscle weakness, tenderness, or pain
• Nausea, vomiting, and stomach pain
• Brown or dark urine
• Tiredness
• Yellowness of the skin and whites of the eyes
• Neuropathy (numbness and tingling) affecting the hands, arms, feet, and legs

What is the complete list of Crestor side-effects?
See: Crestor Side Effects PDF from AstraZeneca

What are some Natural alternatives to Crestor that would not have the same side effects?
Policosanol - a natural extract from sugar cane which has been shown to lower LDL (bad) cholesterol levels as well as raise HDL (good) cholesterol. More importantly policosanol has been proven to be free of side effects, unlike the statins.
Guggulipid Extract - an ancient herb from India recently shown to lower cholesterol levels and can also reduce triglyceride levels, another risk factor for heart disease.
Tumeric Extract - much evidence points to the fact that tumeric may lower cholesterol and triglyceride levels, in addition to its antioxidant and anti-inflammatory properties.
Green Tea Extract - green tea is widely used for many medicinal purposes, and has been shown to reduce triglycerides as well as LDL cholesterol, and increase HDL (good) cholesterol. Green tea also has antioxidants that can prevent heart disease, cancer and other illnesses.

What is Creatine?
Creatinine is a breakdown product of creatine, which is an important constituent of muscle. A serum creatinine test measures the amount of creatinine in the blood.

A creatine serum test is used to determine kidney function. If kidney function is abnormal, the creatinine levels will increase in the blood, due to decreased excretion of creatinine in the urine. Creatinine levels also vary according to a persons size and muscle mass.

CPK levels indicate the status of kidney function.

Creatinine is a breakdown product of creatine, which is an important constituent of muscle. Creatinine can be converted to the ATP molecule, which is a high-energy source. The daily production of creatine and subsequently creatinine, depends on muscle mass, which fluctuates very little.

According to Astra Zeneca, data from clinical trials with CRESTOR and reports from actual patient experience confirm that CRESTOR has a safety profile that is in line with other currently marketed statins.

CRESTOR has been approved and is available for use in 52 countries and has been prescribed more than 16 million times worldwide. You should also know that more than 45,000 patients have taken CRESTOR in clinical trials, including patients on continuous therapy for nearly 4 years. In fact, more patients were studied for the approval of CRESTOR than were studied for any other statin's approval.

http://www.crestorfacts.com/questions.aspx

AstraZeneca, the pharmaceutical company who developed the Crestor medication, has aggressively marketed this Crestor medication, and sold $1 billion in sales in the first year.

Public Citizen has tried to ban Crestor medication, because some studies indicate that under certain circumstance, some people taking Crestor medication suffer harmful side effects. Publice Citizen says that these Crestor medication side effects were present before Crestor gained approval by the US government. A medication similar to the Crestor medication in form and function was recalled in August of 2001 because the serious health risks associated with taking this medication outweighed its intended benefits. Baycol was taken off the medicaiton market when it was shown to cause a serious degenerative muscle disease in its patients.

Crestor medication was approved by the Federal Drug Administration in August 2003.

Crestor Medication Rhabdomyolysis
Adverse reactions from Crestor medication include Crestor medication rhabdomyolysis and kidney failure. Crestor medication rhabdomyolysis is the breakdown of muscle fibers resulting in the release of muscle fiber contents into the blood circulation which can be toxic to the kidneys and can result in myoglobinuria and kidney damage.

Myoglobin is a damaging oxygen-binding protein pigment found in the skeletal muscle. When the skeletal muscle is damaged, myoglobin is released into the bloodstream. It is filtered out of the bloodstream by the kidneys. Myoglobin breaks down into potentially toxic compounds causing kidney failure. Myoglobinuria symptoms include:

• Abnormal urine color (dark, red, or cola colored)
• Muscle tenderness
• Weakness of the affected muscles Generalized weakness
• Muscle stiffness or aching (myalgia)

Health agencies in Canada and the United Kingdom brought to light seven cases of life-threatening Crestor medication rhabdomyolysis and nine cases of kidney failure or Crestor medication kidney damage in patients mostly using lower doses of Crestor medication.

Pharmaceutical watchdog -- the Public Citizen -- representing 160,000 consumers nationwide petitioned the FDA to immediately remove rosuvastatin (Crestor medication) from the marketplace before additional cases of life-threatening Crestor medication rhabdomyolysis, kidney failure and Crestor medication kidney damage occur.

Also, decisions by a few major U.S. health insurers urged doctors that they would not be reimbursed for the medication Crestor due to the high degree of Crestor medication rhabdomyolysis risk, hoping to squelch prescriptions. Based on this information, the Public Citizen strongly urged the FDA not to approve the medicaiton Crestor and subsequently advised people not to use the drug once it was approved. The drug also was linked to some cases of Crestor medication kidney abnormalities not seen with other statins.

Despite the Crestor medication rhabdomyolysis risks, the FDA approved the medication Crestor in August 2003 which had a 2% market share after only three weeks. The manufacturer, AstraZeneca launched an estimated $1 billion first year promotional campaign to persuade doctors to prescribe the medication Crestor, despite the risks of rhabdomyolysis.

AstraZeneca's Crestor dodges an FDA bullet. But, safety issues aside, can the drug compete? And do we really want the safety issues of Crestor to be put aside? Consider the safety of your statin drugs and discuss the alternatives with your doctor. Consider that a warning was issued on use of Crestor by Asians.

The cholesterol drug Crestor is being relabeled to add a caution that starter doses should be reduced in Asian-Americans and some other patients. The FDA has issued a public health advisory to further explain the risks and benefits of the cholesterol-lowering drug Crestor. The drug will now carry a new label that includes new recommended doses for patients at a higher risk of muscle damage, including Asian patients. The U.S. Food and Drug Administration said yesterday the company's cholesterol drug Crestor is no more dangerous than similar treatments such as Pfizer Inc.'s Lipitor, the world's best- selling medicine.

Of course, Baycol, a statin was pulled from the market after many people died or were seriously injured from taking it. And, Crestor is not "just as safe" for all people. The U.S. Food and Drug Administration warned Wednesday that health risks are higher for Asian people than other racial groups using the cholesterol-lowering drug Crestor.
For more: AstraZeneca Rises as FDA Eases Worry of Crestor Risk

FDA issued a public health advisory describing revisions to the WARNINGS, DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY, and PRECAUTIONS sections of the labeling. The revisions include results from a Phase 4 pharmacokinetic study in Asian-Americans and highlight important information on the safe use of Crestor to reduce the risk for serious muscle toxicity (myopathy/rhabdomyolysis), especially at the highest approved dose of 40 mg. At this time, the FDA is also making statements about the muscle and kidney safety of Crestor based on extensive review of available information.

Crestor Side Effects and Symptoms List

Crestor (Rosuvastatin) may cause serious side effects. The symptoms for these side effects of Crestor are listed below. You should consult your doctor if any of these Crestor side effect symptoms are severe or do not go away:

• muscle pain, tenderness, or weakness
• joint pain
• fever, sore throat, chills, or other signs of infection
• dark urine
• numbness or tingling in fingers or toes
• flu-like symptoms
• weakness
• back pain
• joint pain or weakness
• rash
• swelling of the hands, feet, ankles, or lower legs
• chest pain
• pain in upper right part of stomach
• yellowing of the skin or eyes
• painful or difficult urination
• sinus infection
• constipation
• stomach pain
• upset stomach
• heartburn
• diarrhea
• headache
• dizziness
• difficulty falling asleep or staying asleep
• depression
• cough

Rosuvastatin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

In rare cases symptoms of muscle problems and liver or kidney problems have been associated as side effects from the use of rosuvastatin and other similar medicines.

While the FDA has not issued a Crestor recall, Crestor side effect and syptom warnings about the drug's safety continue to bring attention to the dangerous Crestor symptoms of these side effects. The FDA issued a warning on March 4, 2005 about the side effects and symptoms of Crestor.

Studies have shown that blood levels of Crestor in Asian patients were twice those of white patients on the same drug. Crestor, like other statins, has rarely been linked to the Crestor side effects and symptoms of serious muscle damage (rhabdomyolysis). In its warning, the FDA recommended that Asians be started on lower doses to reduce the risk of side effects. The same symptom warning also applies to patients with severe kidney disease and those on cyclosporine. In addition, you should contact your doctor immediately if you experience the symptoms of unexplained muscle pain, tenderness, or weakness, especially if these symptoms are accompanied by a fever or flulike symptoms or yellowing of the skin or eyes, abdominal pain, unexplained fatigue, dark colored urine or pale colored stools. These may be early symptoms of muscle, kidney, or liver problems.

FDA Shows Dangerous Cowardice in Crestor Announcement

Statement of Sidney M. Wolfe, MD, Director, Public Citizen's Health Research Group : For Immediate Release: March 2, 2005

Today's announcement by the U.S. Food and Drug Administration (FDA) concerning revised labeling of the cholesterol-lowering drug Crestor is yet another example of the agency's dangerous cowardice in failing to adequately protect people in this country from uniquely dangerous prescription drugs. Like statements from AstraZeneca, the FDA's statement is replete with false and misleading information. Rather than responding in a public health-positive manner to our March 2004 petition and banning this drug, the FDA has done exactly what AstraZeneca wanted with minimal labeling changes and surely has pleased one of the drug companies contributing to the $150 million in drug industry funding that the FDA is receiving this year for drug review.

Since the last supplement to our petition to ban Crestor (submitted in October 2004), which was based on adverse reaction reports through August 26 of last year, there have been an additional 52 U.S. cases of life-threatening muscle damage (rhabdomyolysis) reported to the FDA and an additional 12 U.S. cases of kidney failure or impairment in people not having rhabdomyolysis reported to the agency up to the end of January of this year. The total of such U.S. cases reported since the drug was first marketed in September 2003 is now 117 cases of rhabdomyolysis and 41 cases of kidney failure, both higher than seen with the other currently marketed statins. Because of concerns about the safety of Crestor, several countries, including Germany, Norway and Spain, have not approved the drug.

Although the increased rate of rhabdomyolysis is not as high as that of the now-banned Baycol, the FDA is well aware that the rate is higher than that of the other statins, a fact it covers up by saying the rate is "similar." The FDA statement also includes other "facts" that are extremely misleading if not false:

FDA Statement: "Data available to date from controlled trials, as well as post-marketing safety information, indicate that the risk of serious muscle damage is similar with Crestor compared to other marketed statins."

Response: Crestor was the only statin that caused rhabdomyolysis at any dose in clinical trials prior to approval. (The cases occurred at 80 mg, a dosage not approved, but most of the post-marketing cases are occurring at 10 or 20 mg.)

FDA Statement: "Mild, transient proteinuria (or protein in the urine, usually from the tubules), with and without microscopic hematuria (minute amounts of blood in the urine), occurred with Crestor, as it has with other statins, in Crestor's pre-approval trials."

Response: Although the FDA admits that with Crestor, "The frequency of occurrence of proteinuria appeared dose-related," it fails to mention that this dose-related increase in proteinuria and hematuria (blood in the urine) was seen only with Crestor and not with any other statin.

FDA Statement: "In clinical trials with doses from 5 to 40 mg daily, this effect was not associated with renal impairment or renal failure (i.e., damage to the kidneys)."

Response: (from FDA medical officer during the July 2003 FDA hearing on Crestor approval): "These three cases of renal insufficiency of unknown etiology are of concern because they present with a clinical pattern, which is similar to the renal disease seen with rosuvastatin in these clinical trials. ... Proteinuria and hematuria could be potentially managed with regular urinalysis screening. However, if they are the signals for the potential progression to renal failure in a small number of patients, this may represent an unacceptable risk since currently approved statins do not have similar renal effects." (emphasis added)

Rather than being a "Public Health Advisory," as the announcement is titled, this FDA statement is more like an AstraZeneca Health Advisory. In its inability to serve two masters, the FDA has sided once again with its funders in the drug industry.

###

Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org.

Frank Clemente
Director, Public Citizen's Congress Watch
215 Pennsylvania Avenue SE
Washington, DC 20003
202-546-4996
F 202-547-7392
Web site http://www.citizen.org

Heart Center Online, Fri, 04 Mar 2005 6:50 AM PST HeartCenterOnline For Patients
The U.S. Food and Drug Administration (FDA) announced Wednesday that a new warning should be added to Crestor that applies to Asians. Then, Thursday, after the FDA said that the company's cholesterol drug, Crestor, did not carry higher risks than its rival drugs. As a result, shares in pharmaceuticals giant AstraZeneca lifted 4% yesterday after safety fears surrounding one of its blockbuster drugs were dispelled in the US. American regulators said cholesterol-lowering drug Crestor was not more likely to cause muscle damage than similar treatments.

It causes me to wonder what $150,000,000 in political contribtuions buys the Pharma industry in influence over decisions like these!

Health Canada has warned Asians using the cholesterol drug Crestor to reduce their dosage. In its warning, Health Canada warned taht the daily doses of the cholesterol drug Crestor should be severely reduced for people of Asian descent and other patients displaying risk factors for muscular problems. In addition, the FDA issued a caution for the use of cholesterol drug Crestor by Asians. As a result of late FDA actions, the cholesterol drug Crestor is being relabelled to add a caution that starter doses should be reduced in Asian-Americans and some other patients.

What is Chronic Renal Failure? : A gradual and progressive loss of the ability of the kidneys to excrete wastes, concentrate urine, and conserve electrolytes. Chronic renal failure is also known as chronic kidney failure, renal failure, renal insufficiency, and CRF. Chronic renal failure (CRF) is the progressive loss of kidney function. The kidneys attempt to compensate for renal damage by hyperfiltration (excessive straining of the blood) within the remaining functional nephrons (filtering units that consist of a glomerulus and corresponding tubule). Over time, hyperfiltration causes further loss of function.

What causes chronic renal failure? : Chronic renal failure occurs slowly. Rapid loss of kidney function is known as acute renal failure. There are many things that can chronically cause a loss in renal function. Sometimes, this can occur very slowly, with little sign or symptom of failure occurring.

Renal failure can be cause by diabetes, hypertension. It can also be caused by glomerulonephritis of any type (one of the most common causes), polycystic kidney disease, Alport syndrome, reflux nephropathy, obstructive uropathy, kidney stones and infection, and analgesic nephropathy. Some drugs have been known to cause renal failure, such as the drug Baycol, which was withdrawn from the market. Chronic renal failure results in the accumulation of fluid and waste products in the body, causing azotemia and uremia. Azotemia is the build-up of nitrogen waste products in the blood. It may occur without symptoms. Uremia is the state of ill health resulting from renal failure. Most body systems are affected by chronic renal failure. Fluid retention and uremia can cause many complications (see Complications).

According to Public Citizen, "... cases of renal insufficiency of unknown etiology are of concern because they present with a clinical pattern, which is similar to the renal disease seen with rosuvastatin in these clinical trials. Proteinuria and hematuria could be potentially managed with regular urinalysis screening. However, if they are the signals for the potential progression to renal failure in a small number of patients, this may represent an unacceptable risk since currently approved statins do not have similar renal effects."

According to AstraZeneca, the maker of Crestor, rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with CRESTOR and with other drugs in this class. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. Therapy with CRESTOR should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected.

Preventing Renal Failure: AstraZeneca recommends that liver function tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (eg, semiannually) thereafter.

Treatment of the underlying disorders may help prevent or delay development of chronic renal failure. Diabetics should control blood sugar and blood pressure closely and should refrain from smoking.

What are the symptoms of renal failure: Early on, you may see weight loss, nausea, vomiting, general ill feeling, fatigue, headache, frequent hiccups, generalized itching (pruritus). Later, other symptoms can develop as a result of renal failure. THese may include: changes in urine output, the urge to urinate throughout the night, easy bruising or bleeding, blood in the vomit or in stools, decreased alertness, drowsiness, somnolence, lethargy, confusion, delirium, coma, muscle twitching or cramps, seizures, uremic frost--deposits of white crystals in and on the skin, decreased sensation in the hands, feet, or other areas.

What will tests show?

• Protein or other abnormalities which can be detected in tests as early as 10 or more years before symptoms appear.
• Creatinine levels progressively increase.
• BUN is progressively increased.
• Creatinine clearance progressively decreases.
• Potassium test may show elevated levels.
• Arterial blood gas and blood chemistry analysis may show metabolic acidosis.

Public Citizen consumer group petitioned the FDA to immediately remove Crestor from the market because of safety concerns, including Crestor deaths reported after life-threatening instances of rhabdomyolysis developed.

However, AstraZeneca denies Crestor linked to any deaths. http://www.laleva.org/eng/2004/05/astrazeneca_denies_crestor_linked_to_any_deaths.html

Other statins include Pravachol, Mevacor, and Lescol -- and now ultra-potent Crestor. Until 2001, there was another statin: Baycol. It was then the newest statin and a potent statin -- until it was withdrawn because of dozens of deaths. Is Crestor another Lipitor or another Baycol? Although Crestor has been on the market only a year, it has already been linked to numerous cases of severe muscle breakdown, kidney toxicity, and deaths. Public Citizen recently petitioned the FDA to ban Crestor. http://www.medicationsense.com/articles/july_sept_04/crestor_truth.html

When Baycol was withdrawn because of dozens of deaths, Newsweek asked me what I thought. My response: "I think it's frightening that 800,000 people were taking Baycol. Baycol was the newest and least known statin, and it offered nothing superior to other statins. No one should have been exposed to Baycol unless the other five statins had been tried first unsuccessfully, and that is very few people.22" My opinion remains exactly the same about Crestor. http://www.medicationsense.com/articles/july_sept_04/crestor_truth.html

What is the significance of Muscle Pain from crestor?

Crestor can cause muscle pain. This muscle paind can be a symptom that Crestor is not being properly utilized by your body. Among the more serious side effects is the symptom of muscle pain from taking Crestor.

Crestor muscle pain symptoms indicate that there is waste product in the blood stream -- this waste product is often protein from the muscles. The muscle pain occures because the body is metabolizing the muscles. This may also indicate a more serious condition known as Rhabdomyolosis. Rhabdomyolosis is a painful condition, and can result in fatal degenerative muscle disease. The condition causes damage to both the bones and muscles -- and causes the muscles to atrophy.

Crestor muscle pain is caused by high levels of potassium and myoglobin being released into the blood stream. These protiens then reduce circulation which can also cause kidney damage. THe filtering ability of the kidneys become impaired.

Crestor muscle pain is a warning sign of more serious problems such as acute renal failure or extensive damage to other organs of the body. Anyone taking Crestor, who is experiencing muscle pain should consult their physician immediately. The Crestor muscle pain may be a sign of rhabdomyolosis. Crestor muscle pain may also be accompanied by weakness or tenderness in the body, nausea and vomiting, a fever, and abnormally dark urine.

Muscle pain is a symptom that occurs with certain statin drugs. In fact, Baycol was pulled off of the market due to these side effects.

Please call your doctor as soon as possible and tell him how bad the leg pain is. This muscle pain is a tell-tale sign of potential danger. The most common side effects of rosuvastatin are headache, nausea, vomiting, diarrhea and muscle pain. The most serious side effects are liver failure, muscle breakdown (rhabdomyolysis) and kidney failure. Muscle pain is a sign that Crestor may be a problem for you. Speak to your doctor about this, immediately.

AstraZeneca Crestor should be required for the statin?s highest proposed dose of 40 mg, FDA?s Endocrinologic & Metabolic Drugs Advisory Committee recommended June 9.

... "In this group of patients who are getting statins, many of them will have comorbid conditions that require renal function monitoring anyway [such as] hypertension [or] diabetes but I do think that there should be a clear statement in the labeling that individuals who receive 40 mg" should be monitored, he said.

Crestor and Kidney hemorrhage - What is the relation?

Did you know that Crestor interacted dangerously with the blood-thinner Coumadin, commonly used by heart-disease patients; one Crestor-Coumadin interaction resulted in a hemorrhage according to reports listed in FDA materials.

Also, among six patients, Crestor interacted dangerously with the blood-thinner Coumadin, commonly used by heart-disease patients. One had a hemorrhage, Sidney Wolfe of Public Citizen has said.

The FDA sees a higher Crestor risks for Asians. Despite this fact, Crestor won approval in January from the Japanese government, allowing for marketing in Japan of Crestor for treating high cholesterol.

CAUTION IS ADVISED when using this medicine in Japanese or Chinese patients because they may more sensitive to the effects of this medicine, especially the effects on the muscles. Therefore, you should tell your doctor if you are of Japanese or Chinese descent. You may need a slightly different dose of this medicine.

There are many factors related to how Crestor will be tolerated. These factors include: kidney problems, an underactive thyroid gland, alcohol abuse, a past history of significant muscle pain or significant muscle weakness while on statin therapy, a personal or family history of inherited muscle problems, and Japanese or Chinese ethnicity.

A study summarized in the original product labeling for Crestor, had found a twofold increase in drug exposure among Japanese residents of Japan and Chinese residents of Singapore, compared with Caucasians in North America and Europe. The new study, according to the labeling (PDF) released today by FDA, involved U.S. residents of Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian origin.

Asian-Americans Among Groups More at Risk of Serious Muscle Damage

The FDA has issued a public health advisory to further explain the risks and benefits of the cholesterol-lowering drug Crestor. The drug will now carry a new label that includes new recommended doses for patients at a higher risk of muscle damage, including Asian patients. The new label adds a clearer warning regarding the risk of rare muscle-weakening side effects that can lead to kidney damage or death.

The Food and Drug Administration warned the public Wednesday about risks of muscle damage from AstraZeneca Plc's cholesterol-lowering drug Crestor but said the risks were like those of similar drugs in the family called statins.

Reuters via Yahoo! News, Tue, 08 Mar 2005 1:31 PM An unusual cholesterol drug study focusing on black Americans shows that AstraZeneca Plc's Crestor lowers levels of a protein that may predict a person's risk of serious heart disease. AstraZeneca Presents New Data Demonstrating CRESTOR(R) Reduced C-Reactive Protein Levels in African-American Patients. In an African American Rosuvastatin Investigation of Efficacy and Safety, data presented today at the American College of Cardiology's Annual Meeting (ACC) show that AstraZeneca's CRESTOR(R) (rosuvastatin calcium) at 10 and 20 mg reduced levels of C-Reactive Protein (CRP) by 14 and 19 percent, respectively, while atorvastatin 10 and 20 mg.

But a Food and Drug Administration (news - web sites) analysis published last week concluded that while Crestor could cause serious muscle damage, it was no worse than other statin drugs.

Bayer AG's statin Baycol was pulled from the market in 2001 after it was linked to more than 100 deaths, many from a severe muscle-damaging condition called rhabdomyolysis.

The best online resource for information about drugs like this is the one operated by Public Citizen. They post well-researched warnings about dangerous medicine week, months, or even years before the information becomes widely known and the FDA is forced to do something about them.

Kidney damage is associated with muscle damage and elevated levels of an enzyme. http://www.uspharmacist.com/index.asp?show=article&page=8_1214.htm See Adverse Reactions

Clinical study data for rosuvastatin document a 0.2% incidence of clinically significant but transient elevations of liver enzyme alanine transaminase.

Jones PH, Davidson MH, Stein EA, et al. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Amer J Cardiology 2003;92:152-160.

http://www.veritasmedicine.com/d_home.cfm?did=174&type=WU&cid=0
Google search term: Crestor kidney damage mechanism
http://www.uspharmacist.com/index.asp?show=article&page=8_1214.htm

Crestor is 75 times more likely to cause kidney damage than other drugs.
http://worstpills.org/results.cfm?drug_id=1025

(December 2004) The letter was prompted by a new Public Citizen analysis of adverse drug reaction reports to the FDA. The analysis found that the rate of reports of kidney failure or damage among patients taking Crestor is 75 times higher than in all patients taking all other statin drugs.
http://www.emedicine.com/recalls-alerts.asp?year=2004

Crestor was contra-indicated for those with: kidney disease and pregnant women.

And, on February 12, 2005, the head of the FDA said Crestor should be a last resort drug, which means almost no one should be taking it.

Google search term: greatest risk for crestor complications rhabdomyolysis

Since there is no requirement for doctors to report this information and no way a medical examiner would be aware of it in most cases, precise information is not possible but here are some links with useful information on mortality rates.

Between August 2003 and mid-April, one study showed that 28 people suffered from rhabdomyolysis. (FDA)

Here is the vendor?s information: http://www.crestor.info/index.asp?did=3430&aid=42234&l1=9&l2=0&ch=Congress+Reports
www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Stories/070903_rosuvastatinR.htm

Additional information www.fda.gov/cder/drug/advisory/rosuvastatin.htm
http://www.emedicine.com/recalls-alerts.asp?year=2004
http://pharma-help.com/crestor

ASTRAZENECA presented new data demonstrating that Crestor? reduced cholestrerol. At the same time, elsewhere, the FDA asked Asians to cut down on Crestor usage, and the Food and Drug Administration (FDA) has asked doctors to severely cut down on daily doses of cholesterol drug Crestor (rosuvastatin calcium). This comes on the heal of label revisions for CRESTOR? being approved by the FDA.

It not clear if the new labels are good or bad for AstrZeneca. AstraZeneca strengthened the warnings on its cholesterol-lowering drug Crestor, which has been dogged by criticism regarding safety since its launch.

Should you participate in a class action for Crestor?

Our belief is that Class Actions are not appropriate for this type of injury. We believe that our clients are better served by filing their claim individually. It is our opinion that as an individual plaintiff, you will get better representation for your case. You will not have the problem of having your case lumped together with all of the other claims in the Crestor class action.

If you have suffered from the serious side effects of kidney damage, renal failure, liver damage, or rhabdomyolysis or if your CPK levels are elevated, we do not think you should go the route of a class action case. Rather, we think your Crestor case is best handled as an individual claim.

Crestor risks are higher than other statins according to muscle damage reports submitted to Astra Zeneca. The rate of serious muscle damage reported in patients who took the cholesterol drug Crestor was six times higher than with similar medicines, a consumer group said on Thursday. Thus, Crestor may be riskier than similar meds. The consumer group that sparked a recent effort to ban the anti-cholesterol drug Crestor says the drug's ability to cause serious muscle damage in users is supported by the U.S. Food and Drug Administration's own adverse event reporting system. US consumer group Public Citizen has claimed that patients using AstraZeneca's cholesterol drug Crestor are six times more likely to suffer muscle damage than other similar drugs.

Meanwhile, AstraZeneca is out promoting the use of its drug. Astrazeneca presented new data demonstrating that Crestor reduced C-reactive protein levels In African-American patients.

No. Crestor has not been the subject of a recall, although some consumer advocates, such as Public Citizen, are calling for a recall (withdrawal of the drug from the market).

Several consumer groups are asking the FDA to recall Crestor due in part to the reported serious complications within five months of Crestor's approval. Advocates of a Crestor recall are pressuring the FDA to reacll this drug from the US market. AstraZeneca continues to maintain that Crestor is safe and does not need to be the subject of a recall. The company has done nothing to suggest that they are considering a Crestor recall.

Public Citizen, a reputable consumer advocate group in the United States, has made several statements calling for a Crestor recall since the drug was approved for sale in the United States. Sidney M. Wolfe, MD, Director, Public Citizen's Health Research Group, criticized the FDA and said that inaction to recall Crestor is yet another example of "the agency's dangerous cowardice in failing to adequately protect people in this country from uniquely dangerous prescription drugs". Below are excerpts from Dr. Wolfe's statement:

In light of the pressure for a Crestor recall by consumer advocates, the FDA has agreed to monitor reports of safety problems associated with Crestor use, but has made no indication that they intend to issue a Crestor recall. Crestor attorneys are representing victims associated with the potential recall of Crestor. To learn more about the side effects of Crestor and the calls for a recall, contact one of our lawyers.

The FDA has once again failed to act in the interests of American people. If readers may recall, Dr. David Graham, the world-renowned expert at the FDA has charged that apart from Vioxx (and sister drugs like Celebrex and Bextra), there were four other dangerous drugs on the market. Crestor was one of them. Crestor, a member of a class of cholesterol-lowering drugs commonly referred to as 'statins', was approved in the U.S. in August 2003. Many consumer rights group have demanded a Crestor recall. On November 19, 2004 FDA associate director of drug safety and 20-year veteran, David J. Graham, suggested strict curbs or a complete recall of 5 drugs that are known to have serious or fatal side effects. The 5 drugs that are of concern include: Accutane, Bextra, Crestor, Meridia, and Serevent.

However, the while FDA has not issued a Crestor recall, it has issued warnings about the drug's safety continue to bring attention to the dangerous Crestor side effects.

What is the Problem with Crestor?

We believe that there is a problem, such as we have seen recently in the news with Vioxx, in that the FDA has not always been a good regulator in recent years. This may leave people at risk of taking drugs that may later turn out to be dangerous. For example, on March 4, 2004, Public Citizen called on the U.S. Food and Drug Administration (FDA) to immediately remove the cholesterol-lowering drug rosuvastatin from the market. The drug, marketed by AstraZeneca as Crestor, has been linked to cases of life-threatening muscle damage and kidney failure or damage.

However, according to counsel for AstraZeneca, there is no Crestor problem. In a letter to this firm, they believe, and we agree, that patients should not be discouraged from following the advice of their physicians.

Despite the problems we have seen, we agree with AstraZeneca's attorney that patients should follow the "advice of their physicians that they use FDA-approved therapies." Further, according to AstraZeneca's attorney "[f]or persons taking Crestor on their physicians' advice," they should not "stop taking the drug without the knowledge of their physician" as this "may result in serious complications and injury." We agree with AstraZeneca that it is important that the medical community maintain the "ability to convey accurate information to patients and to provide needed professional medical assistance." Please consult your physician regarding any questions or concerns that you have regarding medications and medical treatment.

The problem according to another press release from Public Citizen, is that "[i]t becomes clearer by the day that this drug is uniquely toxic without offering any unique benefit, and that it must be removed from the market". However, according to counsel for AstraZeneca, in a letter to this firm, "studies have shown that Crestor offers features unique among the currently marketed statins, including: (1) the greatest efficacy for lowering serum LDL cholesterol; and (2) significant increases in beneficial HDL-C."

Is it a Crestor problem? Or is the problem bigger than Crestor? The problem is that the pharmaceutical lobbyists give astronomical sums of money to presidential and other political candidates. Just as these pharmaceutical manufacturers complain of the monies given by Trial Lawyers to political candidates in order to help maintain access to the civil justice system for individuals who have been harmed by unsafe drugs, one can only wonder what the pharmaceutical lobbyists expect as a result of making their large political contributions.

Crestor is the only statin to display these problems during its pre-approval studies and still gain approval by the FDA. The approval of rosuvastatin (Crestor) is problematic because it follows the recall of Bayer?s cerivastatin (Baycol) which was also a super-statin. In 2001, Baycol was removed from the market because it caused life threatening side effects like rhabdomyolysis, a fatal muscle disorder. Side effect problems were reported with Crestor that appeared reminiscent of the Baycol experience. Cases of rhabdomyolysis were seen with Crestor during drug trials, particularly with the 80 mg. dose.

What is rhabdomyolysis? Rhabdomyolysis is the breakdown of muscle tissue that is accompanied by the release of muscle cell contents into the bloodstream resulting in blood problems and sometimes, serious kidney damage. According to the FDA, do not take Crestor if you: have certain liver problems .

Yet again, the FDA has warned AstraZeneca on Crestor. On the heels of prior warnings to AstraZeneca, and in response to further problems, AstraZeneca PLC has received a second warning in four months from the U.S. Food and Drug Administration over what the agency says are misleading claims in its ads for cholesterol-lowering medicine Crestor. Warnings added to anti-cholesterol drug Crestor last week sharply understate the drug's risk, the consumer group Public Citizen said Thursday in a letter to the FDA reiterating its request to have the drug pulled from the market. Yet, Crestor warnings remain too weak says Public Citizen. Now, in a warning letter, an FDA official says some ads were misleading about the cholesterol drug's superiority. In fact, the rate of serious muscle damage reported in patients who took AstraZeneca Plc's cholesterol-lowering statin drug Crestor was six times higher than with similar medicines, a consumer group said on Thursday.

This just reinforces the facts that the Food and Drug Administration needs an independent office that would monitor the safety of drugs it approves and warn the public of emerging risks. There are now even Senators who are Republican that are calling for this, new reports said Thursday.

AstraZeneca PLC has received its second warning in four months from the U.S. Food and Drug Administration over what the agency says are misleading claims in its ads for cholesterol-lowering medicine Crestor. THe FDA Warned AstraZeneca on the cholesterol drug's advertisements. The report issued by The U.S. Food and Drug Administration has again warned the drugmaker AstraZeneca about misleading advertisements that claim its cholesterol-lowering drug Crestor is more effective than Pfizer's Lipitor, Forbes.com reported. It marks the second time in four months the agency has warned the company about misleading ads for the drug, Forbes.com

PUBLIC CITIZEN PRESS RELEASE March 14, 2005

In Refusing to Ban Crestor, FDA Chooses Drug Company Over Safety

Statement of Sidney M. Wolfe, MD, Director, Public Citizen's Health Research Group

The U.S. Food and Drug Administration's (FDA) denial today of our petition to ban Crestor has a familiar ring in its similarity to the agency's initial response to the dangers of many other drugs that were eventually banned. This response should give no comfort to either physicians or patients who are using or considering using Crestor. More than a year before Baycol was banned because of its uniquely high rate of rhabdomyolysis compared to other statins, the FDA was aware of this difference, as was the agency more than two years before the diabetes drug Rezulin was banned because of liver toxicity. Four years before Vioxx was banned, the FDA refused to even require a black box warning about known increased risk of heart attacks.

We are aware that because of its concerns about the increased rate of rhabdomyolysis and unique kidney toxicity of Crestor, the agency at least considered warning that the drug should be a last-choice drug for lowering cholesterol. Although this would not have been preferable to banning the drug, it would have been a much less reckless choice than merely allowing cosmetic labeling changes to be made.

*On page 16 of its response to Public Citizen's petition to ban Crestor, the agency admits that although "estimates of the reporting rate [for rhabdomyolysis] are higher than those of other marketed statins, the time period [post-Baycol] conceivably contributed to the enhanced reporting ... because of publicity." This is absurd since our recent analysis of the most recent year of rhabdomyolysis data on all of the statins, showing the rate for Crestor to be 6.2 times higher than other statins combined, covered a period from 10/03 through 9/04, during which the reporting of all statins would have been affected by the "Baycol effect."

*While acknowledging (page 27) that as many as 15 cases of kidney failure with Crestor had a "history supporting possible direct causation by Crestor," a similar analysis was not done for cases of renal failure reported with other statins. The agency also states (p. 30) that "neither does a review of the cases fully dispel concerns of possible renal effects of Crestor that might, in some instances, result in renal insufficiency or failure." Thus, our earlier statement that the rate of such reports is much higher with Crestor compared to other statins is not rebutted.

Once again, when faced with concerns about the safety of a drug, the FDA has sided with the drug company, AstraZeneca, instead of the public. When Crestor is taken off the market, if not before, this will represent yet another blow to the agency's badly tarnished reputation.

Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org .

AP via Yahoo! News, Mon, 14 Mar 2005 1:51 PM PST
FDA Rejects Petition to Ban Crestor.

The Food and Drug Administration said Monday it has rejected a petition to remove the cholesterol drug Crestor from the market. The Food and Drug Administration on Monday rejected a petition from a consumer group that sought the ban of the cholesterol fighting drug Crestor manufactured by AstraZeneca. This means that the FDA formally denied Public Citizen's Health Research Group's petition to have Crestor removed from the market. Public Citizen's Health Research Group's (HRG) had filed a petition to remove CRESTOR(R) (rosuvastatin calcium) from the market.

How can this be?

The FDA has rejected a petition to ban Crestor, and goes as far as saying that the anti-cholesterol drug Crestor does not pose a greater risk of muscle damage than other drugs like it.

Dr. Sidney M. Wolfe of the consumer group Public Citizen had petitioned the agency to remove the drug from sale, citing reports of muscle toxicity and kidney damage.

Wolfe goes on to say, "We are aware that because of its concerns about the increased rate of rhabdomyolysis and unique kidney toxicity of Crestor, the agency at least considered warning that the drug should be a last-choice drug for lowering cholesterol. Although this would not have been preferable to banning the drug, it would have been a much less reckless choice than merely allowing cosmetic labeling changes to be made.

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http://www.thestreet.com/stocks/robertsteyer/10213507.html

Pressure on Crestor is mounting with the FDA's second warning about Crestor. The Food and Drug Administration has issued a second warning letter to AstraZeneca regarding the marketing of its cholesterol-lowering drug Crestor. However, AstraZeneca shares closed up after the US FDA formally denied a petition to remove the group's Crestor cholesterol drug from the market. But the FDA warned AstraZeneca on Crestor Marketing. This marks the second time in four months from the US Food and Drug Administration over what the agency says are misleading claims in its ads for cholesterol-lowering medicine Crestor. The FDA sent AstraZeneca a letter regarding Crestor advertisements. The Food and Drug Administration today posted a letter sent to AstraZeneca Pharmaceuticals LP regarding direct to consumer advertisements for the drug Crestor.

The warnings added to anti-cholesterol drug Crestor last week sharply understate the drug's risk, the consumer group Public Citizen said Thursday in a letter to the FDA. The rate of serious muscle damage reported in patients who took AstraZeneca Plc's cholesterol drug Crestor was six times higher than with other statins, says the group.

FDA rejects Public Citizen's petition for AstraZeneca's Crestor. AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has formally denied Public Citizen's Health Research Group's (HRG) petition to remove CRESTOR(r) (rosuvastatin calcium) from the market.

The Star Online, Mon, 21 Mar 2005 4:45 PM PST

RESEARCHERS in Singapore have raised the alarm over a cholesterol-lowering drug which a landmark study indicates has potentially more harmful side-effects in Asians than in Caucasians.

Different doses of the same drug have to be prescribed for Asians and Caucasians. It has come to light that the popular cholesterol-reducing drug Crestor (rosuvastatin) induces more harmful side-effects in Chinese than in Caucasians.

The study found that the concentration of the popular drug Crestor (rosuvastatin) that lingered in Chinese people was twice that in Caucasians, despite both taking the same dosage of the medicine

The American Food and Drug Administration (FDA) advised doctors to reduce the dosage of rosuvastatin in Asians late last year, and the Health Sciences Authority (HSA) in Singapore was also alerted, said Prof Lee.

The FDA says it will not pull the cholesterol pill Crestor from the U.S. market. The announcement comes in response to a petition from the consumer group Public Citizen, which said Crestor leads to increased risk of muscle and kidney damage in some patients. The FDA rejected the claims in a 36-page report responding to the petition. To learn more on this topic, be sure to also read the related article, Pharmaceutical advertising turns national newspapers into drug industry puppets.

Meanwhile, a New York Times headline blares, "Health Officials Urge Sharply Lower Cholesterol Levels," and the article discusses all the reasons why more and more people should be on statin drugs. Changes in diet, nutrition and levels of physical exercise are utterly absent from the story, leaving the reader with only one conclusion: statin drugs are the only way to lower cholesterol. While to the right of the story, a giant tower banner ad demands, "Talk to your doctor today!" Right above that giant quote, a large logo advertises "Crestor," a popular statin drug. The tower banner takes up almost as much screen space as the article, and the message of the two -- in combination -- is quite clear: everybody needs lower cholesterol, and the only way to do that is to take Crestor.