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Crestor: Lawyer: Monheit Law : Crestor News Blog Home : February 2005
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.
Dangerous Practices: Crestor issues and side-effectsFebruary 5, 2005 14:59 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. ...
"Crestor advertisments must go," says FDAFebruary 6, 2005 14:23
http://www.newstarget.com/003537.html
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Last year, Public Citizen, a consumer group that has demanded that Crestor be withdrawn, identified a Crestor patient who developed rhabdomyolysis and later died.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.
Experts opposed high dose of cholesterol drug CrestorFebruary 10, 2005 14:58
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
Regulators did not want the top 40 milligram dose of Crestor to be approved, arguing it was unsafeFebruary 12, 2005 14:55 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
David Graham's comments on Crestor.February 12, 2005 15:02 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.
How should I take Crestor?February 14, 2005 17:45 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.
Crestor and Other Statins: Are They Really Worth the RiskFebruary 15, 2005 17:48
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.
What are the possible side effects of Crestor?February 16, 2005 17:47
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
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.
Can I get Crestor for free?February 18, 2005 17:29 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 should only be used as last resort, says FDA chiefFebruary 19, 2005 14:52
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.
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 .
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.
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.
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
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/questions.aspx
Q: There has been a lot of attention lately about CRESTOR - should I stop taking it?
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
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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