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The FDA delayed approval of Crestor for a year after the drug agency expressed concern about Crestor side effects associated with 80-milligram doses. In May 2002, the FDA told AstraZeneca that it would need to resolve the agency's concerns of potential kidney and muscle damage prior to being granted sales in the U.S. While all statins are associated to rare instances of rhabdomyolysis, a breakdown of muscle cells, Crestor had shown in studies before its approval that the potentially deadly disease had surfaced in seven people.

Public Citizen represents about 160,000 U.S. consumers and has been warning consumers about dangerous and deadly drugs since 1996, including cholesterol drug Baycol. Baycol was recalled in the fall of 2001 after at least 31 reports of fatal instances of rhabdomyolysis. Dangerous and deadly as Baycol was, it still was not linked to rhabdomyolysis in pre-approval clinical studies like Crestor was. In addition, Crestor side effects include instances of kidney problems not caused by rhabdomyolysis, the only statin on the market with this link.

The consumer group strongly urged the FDA not to approve the drug in July 2003 because of the concerns of deadly Crestor side effects. Crestor side effects included risks of muscle and kidney damage while failing to show the ability to reduce the risk of heart attacks and strokes, as well as to lower cholesterol levels, according to Public Citizen. The allowance of Crestor on the market despite what Public Citizen director Sidney Wolfe describes as a "unique toxicity that distinguishes this drug from the other statins" is part of the reason the group petitioned the FDA to immediately remove Crestor from the market on March 4, 2004.

Crestor & Kidney Pain

Crestor side effects have been reported in three U.S. patients taking approved doses within just over five months Crestor has been on the market. The patients suffered kidney failure or muscle damage, including a 39-year old woman that died of kidney failure and rhabdomyolysis. There have also been seven cases of rhabdomyolysis and nine cases of kidney damage or failure that has occurred based on data obtained from the U.S., UK, and Canada.

Even though the FDA was initially concerned with Crestor side effects occurring with 80-milligram doses, when the agency approved Crestor it had concluded it was safe for use at doses up to 40 milligrams. In the Public Citizen petition, it was noted that the Crestor side effects suffered in all but one of the 22 reports occurred at doses between 10 milligrams and 40 milligrams. An FDA spokeswoman commented that based on the data at hand, Crestor side effects are not posing enough of a risk to classify it as an unsafe and ineffective drug.

The Public Citizen, on the other hand, believes deadly Crestor side effects have been evident before FDA approval and it was enough evidence to show it should never have been allowed onto the market. There have been over 2 million Crestor prescriptions written. The FDA is currently reviewing Public Citizen's latest request regarding Crestor side effects and the removal of it from the shelves. Due to the launch of major direct to consumer advertising that AstraZeneca is launching to promote Crestor, the advocacy group believes there is a more immediate urgency to resolving the matter.

If you or a loved one has been harmed by the cholesterol drug, Crestor, you should contact a defective drug lawyer right away.

"Possible Crestor®-Heart Failure Link"

Some researchers believe the cholesterol medication Crestor® (rosuvastatin) can increase the severity of heart failure in certain patients.

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"FDA rejects petition to ban Crestor"

The consumer advocacy group Public Citizen submitted a petition to the FDA a year ago asking the agency to immediately withdraw the anti-cholesterol drug Crestor, but the agency has denied its request.

Crestor belongs to a group of drugs ...

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"Asians taking Crestor may be at higher risk for rhabdomyolysis"

The FDA has announced that Crestor is being relabeled to add a warning that starter doses should be reduced in Asian-American patients, as well as some other higher risk patients.

A clinical trial found that levels in Asian patients were d...

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