No Black Box for Crestor

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, called the FDA's decision "another example of the agency's dangerous cowardice in failing to adequately protect people in this country from uniquely dangerous prescription drugs."

Approved by the FDA in August 2003, Crestor hasn't achieved the sales growth that the company or financial analysts had expected thanks in part to critics such as Public Citizen, the British medical journal The Lancet and the veteran FDA researcher Dr. David Graham. During a Senate hearing in November about Merck's arthritis drug Vioxx, Graham told legislators that several other drugs on the market, including Crestor, should be reviewed, restricted or removed.

AstraZeneca has vigorously defended the safety of the drug -- sometimes too vigorously. In December, the FDA told it to stop running a Crestor advertisement, even thought AstraZeneca already had halted the ad.

New Cautions

The FDA's public health advisory says the new label contains a bolstering of the warning that people who take the highest daily dose -- 40 milligrams -- have the highest risk of the muscle disease. The agency said doctors should never prescribe 40 milligrams as a starting dose; it should be prescribed only if a patient hadn't achieved success with 20 milligrams.

The revised label tells doctors to start patients on the lowest daily dose -- 5 milligrams -- if they don't need aggressive lowering of their serum cholesterol. The lowest dose also should be prescribed for patients most at risk for the muscle disease -- Asians; people with kidney problems; or people taking the drug cyclosporine, a treatment for patients with transplated organs and with some autoimmune diseases.

The FDA also said doctors should monitor patients for protein in the urine, a potential indicator for kidney problems. The frequency of this condition -- called proteinuria -- appears to be related to the dose, said the FDA. It said clinical tests for Crestor at daily doses below 40 milligrams didn't show a link between this condition and kidney disease.

"If a patient on Crestor develops unexplained, persistent proteinuria," doctors should cut the dose and look for other possible causes, the FDA said.

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