It was the best of statins, it was the worst of statins. The anticholesterol drug cerivastatin, sold under the brand name Baycol, was the most potent medicine in its class in the late 1990s. In 2001, however, it was ripped from the marketplace after being linked to an unusually high incidence of a rare, but sometimes deadly, side effect. In certain respects, the compound's meteoric career portended the recent deluge of bad news about one drug after another. ...

Regulatory action may yet kill other effective medications that, used more discerningly, could genuinely benefit an important minority of patients. One drug that might face that fate is the statin rosuvaslatin, which manufacturer AstraZeneca of London launched in September 2003 under the brand name Crestor. ...

Of all statins, Crestor was the one most comprehensively studied before it was marketed, counters AstraZeneca's Gunnar O. Olsson of Mlndal, Sweden. A high dose that caused side effects in early trials was never sold, he notes. ...

If inappropriate use causes preventable side effects, as Wolfe and Graham suggest, then Crestor could get the hook just as Baycol and Vioxx did. For people who truly need Crestor, says Strom, its premature exit would be a step back in medical progress. ...

http://www.newstarget.com/003537.html
FDA asks AstraZaneca to pull its ads for Crestor... The FDA has told AstraZaneca to pull its ads for Crestor, a popular cholesterol reducing drug, because they do not mention its risks of causing acute kidney failure or rhabdomyolysis, a life-threatening muscle disorder. The FDA has been carefully watching the the drug following its approval and have several concerns about its side effects. Though AstraZaneca denies the FDA's claims, they have stopped their advertisements. If you find this article interesting, be sure to also read 'American Medical Association calls for wholesale reforms of the FDA.'

• FDA whistle-blower David Graham, in testimony before a Senate committee Nov. 18, named Crestor as one of five drugs that pose serious safety concerns.
  
• "The scientists at the FDA who are responsible for the approval and ongoing review of CRESTOR have, as recently as last Friday (Nov. 19), publicly confirmed that CRESTOR is safe and effective; and that the concerns that have been raised have no medical or scientific basis," the ad stated, citing the FDA Web site.

AstraZeneca Plc, Europe's third biggest drugmaker, said the doctor treating a patient who died while taking cholesterol reducer Crestor ruled the death was probably caused by an infection rather than a side-effect associated with the medication. http://www.bloomberg.com/apps/news?pid=10000102&sid=a7bNXLy1TF0c&refer=uk

Last year, Public Citizen, a consumer group that has demanded that Crestor be withdrawn, identified a Crestor patient who developed rhabdomyolysis and later died. The patient's death was subsequently ruled to have been because of a heart attack.

Kidney damage was seen in patients during clinical testing of Crestor, although primarily in patients taking an 80-milligram dose, more than the highest dose the company sells.

Health-care regulators did not want the top 40 milligram dose of AstraZeneca's cholesterol drug Crestor to be approved, arguing it was unsafe, according to published committee minutes. The Guardian said on Thursday that members of the Committee on Safety in Medicines expressed concerns that the 40 mg dose could cause a rare and potentially fatal muscle wasting condition
http://today.reuters.co.uk/News/newsArticle.aspx?type=topNews&storyID=2005-02-10T020721Z_01_CAS007283_RTRUKOC_0_HEALTH-ASTRAZENECA-CRESTOR-TOP.xml

AstraZeneca's cholesterol-lowering drug Crestor should only be used after all other alternatives have failed, ... that Crestor had "unique toxicity" caused ... a result Crestor should only be used "as a second line drug when people have failed to respond to other statins," ... safety of Crestor last November when he named it among five medicines on the market that needed closer safety scrutiny.... regulators did not want the top 40 milligram dose of Crestor to be approved, arguing it was unsafe... ...the FDA continues to back the drug despite Graham's comments... confident about Crestor's prospects: "It will certainly take longer, but nothing has changed in the profile (of Crestor) to say that we shouldn't get a very substantial share of the market," he said. http://today.reuters.co.uk/news/newsArticle.aspx?type=businessNews&storyID=2005-02-12T114547Z_01_CUT242001_RTRUKOC_0_HEALTH-ASTRAZENCA-CRESTOR.xml

Dr. Graham has warned that Crestor is among five drugs he thinks should be pulled from the market, or at least considered to be dangerous enough for further study.

Take Crestor exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. Take each dose with a full glass of water. Crestor can be taken with or without food. Crestor is usually taken once a day. Try to take each dose at the same time daily. Follow your doctor's instructions. It is important to take Crestor regularly to get the most benefit. Do not stop taking Crestor without first talking to your doctor. It may be weeks or months before beneficial effects are seen from this medication. Your doctor may want to monitor your liver function with blood tests before starting treatment with Crestor, at twelve weeks after start of treatment and after any increase in dose, and periodically (every 6 months) thereafter. Depending on the results of these tests, your doctor can determine how much monitoring you will require. Eat a low-fat, low-cholesterol diet. To realize beneficial effects from Crestor, avoid fatty, high-cholesterol foods. Store Crestor at room temperature away from moisture and heat.

According to: http://www.mercola.com/2003/nov/8/crestor_statins.htm# In August 2003, AstraZeneca released their new statin called Crestor (generic name rosuvastatin). According to the company, Crestor is less expensive and more effective than similar drugs like Pfizer?s Lipitor, which is currently the statin market leader, taking in about $8 billion of the $13 billion total statin sales in 2002.

Of course, all statins pose risks, so the question of which statin is most dangerous is somewhat tongue-in-cheek. Dangers of statin drugs include, but are not limited to, a potential increase in liver enzymes so patients must be monitored for normal liver function, muscle aches, weakness, immune system suppression, an increase in cancer risk, and a serious degenerative muscle tissue condition called rhabdomyolysis.

In light of these reports, and the known dangers of statin drugs, you would expect some major news in the area of statins, but the studies received hardly any mainstream media coverage. As with many health care issues, you?ll have to sort out the truth for yourself.

Rare cases of muscle problems and liver problems have been associated with the use of Crestor and other similar medicines. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if 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 or liver problems.

If you experience a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) stop taking Crestor and seek emergency medical attention or contact your doctor immediately.

Other, less serious side effects may be more likely to occur. Continue to take Crestor and talk to your doctor if you experience
? headache;
? diarrhea or constipation; or
? nausea or upset stomach.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

According to Astra Zeneca, 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. Get a free 15-day trial of CRESTOR 10 mg when you print a voucher and ask your doctor about CRESTOR.

Crestor, AstraZeneca's most important new drug, should only be used after every other alternative has failed, David Graham, the outspoken government scientist in America's Food and Drug Administration, has said...

The FDA approved CRESTOR in August 2003 after a rigorous examination of CRESTOR safety and efficacy data from clinical trials involving more than 10,000 patients.
http://www.crestorfacts.com

As with all statin drugs, 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), tell your doctor right away .
http://www.crestorfacts.com

The annual report shows the group is facing a number of legal actions. The first writs from patients claiming they were injured by taking the cholesterol-lowering drug Crestor have been filed in the US and a class-action suit has been filed in Canada... http://www.guardian.co.uk/business/story/0,3604,1423079,00.html

However, the company said yesterday: "Lawsuits seeking damages from pharmaceutical companies are commonplace in the United States, especially if the drugs in question are widely prescribed. That doesn't mean the claims asserted in those cases have any merit."

WELL... it could also mean that those Crestor claims do have merit!

CRESTOR dose was double recommendation Guardian - UK The UK's drug regulator recommended that patients start on the controversial cholesterol-lowering drug Crestor at half the dose that ultimately went on the ... <http://www.guardian.co.uk/business/story/0,3604,1419060,00.html>

BUSINESS Editor's commentary Time to gamble on the retailers? Times Online - UK ... The furore over the problems with Exanta, which prevents blood clots, and Crestor, the lipid-lowering drug, distracted attention from the overall performance ... <http://business.timesonline.co.uk/article/0,,8210-1496229,00.html>

The UK's drug regulator recommended that patients start on the controversial cholesterol-lowering drug Crestor at half the dose that ultimately went on the market, the Guardian has learned. ...

Rare cases of muscle problems and liver problems have been associated with the use of Crestor and other similar medicines. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if 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 or liver problems.

More than 16 million prescriptions for CRESTOR have been written by doctors worldwide.
http://www.crestorfacts.com

Injured by Crestor?
  Contact a Lawyer at Monheit Law.
    Now! m/evidence.asp

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Crestor.tv new Blog is featured in Blog Street
February 26, 2005 04:36

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What is Crestor?
February 26, 2005 17:44

Crestor blocks the production of cholesterol (a type of fat) in the body. Crestor is used to reduce the amounts of LDL (bad) cholesterol, total cholesterol, triglycerides (another type of fat), and apolipoprotein B (a protein needed to make cholesterol) in the blood. Crestor also increases the level of HDL (good) cholesterol in the blood. These actions are important in reducing the risk of atherosclerosis (fatty deposits in the arteries), which can lead to heart attack, stroke, and peripheral vascular disease. Crestor may also be used for purposes other than those listed in this medication guide.

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What does Astra Zeneca say about side effects of Crestor?
February 27, 2005 17:19

Rhabdomyolysis is a rare but serious side effect of all statins

Rhabdomyolysis is a serious condition that involves muscle damage and affects the kidneys. This condition is known to be a rare side effect of all currently marketed statins, the class of cholesterol medicines that includes CRESTOR.

Although rhabdomyolysis occurs in fewer than 1 in every 10,000 patients taking statins, people at increased risk include those with

• Advanced age (65 years or older)
• An underactive thyroid
• Kidney disease

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. This may be a sign of rhabdomyolysis.

The information on this Web site should not take the place of talking with your doctor or health care professional about how to manage and treat high cholesterol. If you have any questions about your condition, or if you would like more information about CRESTOR or cholesterol, talk to your doctor or pharmacist. Only your doctor can decide if CRESTOR is right for you.

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

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What does Astra Zeneca say about whether you should stop taking Crestor?
February 27, 2005 17:21

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

Q: There has been a lot of attention lately about CRESTOR - should I stop taking it?
A: No, do not discontinue medications without consulting your doctor. Your doctor is fully informed about the benefits and risks of using statins and made an informed decision when he/she chose CRESTOR to lower your cholesterol.

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Should you continue to take Crestor? Why?
February 27, 2005 17:23

According to Astra Zeneca, High cholesterol cannot be cured - but, for many, it can be managed successfully. CRESTOR, together with a healthy diet and regular exercise can be a highly effective combination in cholesterol management. Remember, if you get good results with CRESTOR, and you stop taking it, your cholesterol will likely go back up. To get the most benefit from CRESTOR you should take it every day, exactly as your physician has prescribed - even after any improvement in your cholesterol levels. http://www.crestorfacts.com/questions.aspx

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Crestor Safety - Is Crestor Safe?
February 28, 2005 17:39

AstraZeneca says that Crestor is "proven safety similar to other leading statins".

However, AZ also states, "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."

Crestor statin drug was FDA approved in August 2003. Even before it ever reached approval status, Crestor safety was in question. Public Citizen consumer group strongly urged the FDA not to approve the drug, which resulted in a one-year delay because the agency questioned its safety as well. While the Crestor safety was mainly associated with the 80-milligram doses, all of the adverse event reports but one have so far been made for 40-milligram doses or less of Crestor a day. See: http://www.onlinelawyersource.com/crestor/safety.html

Further, "Asians taking Crestor may be at higher risk for rhabdomyolysis" according to the FDA. A clinical trial found that levels in Asian patients were double those of Caucasians taking the same dose, which can increase the chance of suffering serious muscle damage called rhabdomyolysis.

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