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Research Chemical SciencesUGFREAKeudomestic
napsgeargenezapharmateuticals domestic-supplypuritysourcelabsResearch Chemical SciencesUGFREAKeudomestic

Crestor on Cycle?

some info i have found on this
Crestor is in the popular family of cholesterol-lowering drugs called statins.

It won Food and Drug Administration approval in August, after a delay because of safety concerns: Seven cases of the potentially fatal, muscle-destroying condition called rhabdomyolysis occurred during studies involving patients on an 80-milligram dose. For that rare condition to pop up in clinical trials was unusual — and particularly worrisome since another statin, Baycol, had been pulled off the market in 2001, linked to dozens of rhabdomyolysis-caused deaths worldwide.

In studies, Crestor also was linked to some cases of kidney abnormalities not seen with other statins.


Still, FDA ultimately decided to approve Crestor, saying it appeared to be slightly more potent than other statins and thus may be important for some patients. To lower the risk of side effects, FDA recommended starting doses of 5 mg. to 10 mg, and said patients should never exceed 40 mg.

But records from the FDA and health agencies in Canada and Britain show life-threatening side effects occur even at those lower doses, said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen, in a petition filed with FDA Thursday seeking a ban.

Among the records:

Seven patients with rhabdomyolysis, including the 39-year-old American who died after using a 20-mg dose, and a second death from an unspecified country.
Four patients with acute kidney failure, including a 79-year-old U.S. man who died.
Five additional patients with less severe kidney damage.
Also, among six patients, Crestor interacted dangerously with the blood-thinner Coumadin, commonly used by heart-disease patients. One had a hemorrhage, Wolfe said.
Crestor maker AstraZeneca wouldn’t comment on the deaths or other serious side effects except to say “the safety profile is totally comparable” to what pre-marketing studies had predicted, said spokesman Gary Bruell.

“We’re very pleased with the performance of the drug thus far,” he said, noting that 1 million patients worldwide have tried Crestor, including 600,000 in the United States. The company is about to begin major television advertising for the drug.

But Wolfe contended that Crestor “has no unique advantage, but some unique risks” over other statins. He told the FDA there is growing concern about the drug, citing two major U.S. insurers who refuse to pay for it because of the muscle risk and a recent recommendation against use by Sweden’s drug advisers.

The FDA will evaluate the petition, said spokeswoman Laura Bradbard.

Source

This entry was posted on Friday, March 5th, 2004 at 8:34 am and is filed under Medicine. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. Tags: cholesterol, Crestor, rhabdomyolysis
 
If you have a doctor monitoring you with your CRESTOR you should be fine.

My apologies, not trying to debate here. Just been in the med field and know that statins are horrible.

Yes prescription drugs effect every person differently, however I am in full belief that while they help one issue they create or magnify another. Why not go all natural root with the cholesterol, such as fish oil, etc?? Why take a statin and then run the HIGH chance of frequent urination, muscle aches, back pain, kidney problems,etc..These are not the typical symptoms, therefor there are more than what I just listed.

Do you honestly feel as though a physician is going to monitor someone closely because they are on a Cholesterol med? I seriously doubt it very much. They will wait for the patient to call/book an appointment because of sides. However, how many people are going to pay attention to side effects on the first alarm?? They typically will wait until their next check up whether 6 months away or 1 yr away, and then it could be too late!
 
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