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The Public Citizen consumer group petitioned the FDA on March 4, 2004 to ban the cholesterol-lowering drug Crestor. Crestor had only been on the market for a little over five months but the consumer group had been against its approval from the start. Based on pre-approval studies, the Crestor patient information that had surfaced was evidence enough not to approve the drug, according to Public Citizen.

With Crestor marketer AstraZeneca getting ready to launch major direct to consumer advertising to promote Crestor, Public Citizen does not want Crestor patient information released with all the adverse effects that have been reported amongst Crestor users thus far. Crestor is a statin drug, the most widely used prescription drug with approximately 11 million Americans using a form of it daily. Alarming, is the early warning signs that Crestor was linked to rare instances of rhabdomyolysis, a side effect of all statin drugs but found to occur in so many Baycol statin users that it led to a fall 2001 recall.

So far, the Crestor patient information reports made have linked the drug to seven instances of rhabdomyolysis and nine instances of kidney failure or damage in the U.S., including the death of a 39-year old woman from kidney damage and rhabdomyolysis. The way that physicians choose prescriptions for patients have been questioned more and more as marketing of drugs continues to increase. Baycol was believed to be a safe additional statin drug but was linked to 31 deaths from rhabdomyolysis before it was recalled.

When the FDA approved Crestor, the agency had concluded after a one-year delay that it was safe when used as directed. The Crestor patient information labeling contains warnings about the potential for rhabdomyolysis and kidney problems, but this information is not enough for the consumer group. According to the director of Public Citizen, Crestor is the only statin on the market that has been linked to kidney problems not caused by rhabdomyolysis, which is a "unique toxicity".

AstraZeneca has been dismissing any concern for the potentially deadly risks saying that it is similar to other marketed statins, but Baycol turned out to be very different. The Crestor patient information appears to have little variation from other statin drugs, but the consumer group thinks that in addition to the risks of rhabdomyolysis and kidney damage, the drug has not been shown to reduce the risk of heart attacks and strokes, as well as to lower cholesterol levels.

As Crestor marketers AstraZeneca will have to face the FDA while the agency determines the future of the drug, consumers may not be receiving all of this Crestor patient information. Billions of dollars are spent on marketing new drugs to physicians and consumers, and drug companies want to highlight the potential benefits of a drug over emphasizing potential risks. The result of efforts has been effective for drug companies that see its new drug go from a virtual unknown to blockbuster hit, but some critics believe this comes with serious risks. With Crestor, some experts believe that the Crestor patient information is not indicating the deadly risks that have been and can be associated to it.

For consumers that are unable to see and comprehend the full parameters of patient information may proceed to request the latest drug believing because they have become familiar with its name through extensive advertising efforts. Since Crestor patient information, in addition to other drug information, is not always provided in simple terms that do not require a physician''s specialized knowledge, deadly and dangerous potential effects are often overlooked. New drugs entering the market have been tested on several hundred to several thousand people, but Crestor, which has so far been prescribed to one million people already, may not have enough information yet to more accurately determine the dangerous effects.

"Possible Crestor®-Heart Failure Link"

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

Coenzyme Q10 (CoQ10), pro...

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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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