A patient taking the cholesterol-lowering drug Crestor (search) has died, the drug's manufacturer reported today.

The death occurred in December 2004. Initial reports suggested the patient died of a muscle-damaging disease linked to Crestor and all other members of the family of cholesterol-lowering drugs known as statins. The same side disease, rhabdomyolysis, drove Baycol off the market.

Rhabdomyolysis (search) is a condition in which muscle cells break down. This floods the blood with muscle proteins, sometimes leading to fatal kidney failure.

Neither Crestor nor any of its sister drugs, which include Lipitor (search), Pravachol (search), and Zocor (search), is as deadly as Baycol (search) was. But some experts say Crestor is more dangerous than the rest of the family. The watchdog group Public Citizen has petitioned the FDA to ban Crestor. And Crestor was one of five FDA-approved drugs named in congressional testimony by maverick FDA researcher David Graham as unsafe.

It's not clear whether the Crestor patient actually died of rhabdomyolysis, says AstraZeneca (search) spokeswoman Emily Y. Denney. AstraZeneca makes Crestor.

"We have received a report of a patient death," Denney tells WebMD. "The initial report listed rhabdomyolysis, but additional follow-up shows the clinical picture to be quite complex. The reported symptoms are more in line with malignant neuroleptic syndrome (search) than with rhabdomyolysis."

Patients with malignant neuroleptic syndrome may have rhabdomyolysis along with a very high temperature and rigidity, but it isn't a common side effect of statin drugs. It's linked to the use of some psychiatric medications.

Despite the death, Denney says Crestor's safety profile is similar to that of other cholesterol-lowering drugs.

"Even if it does turn out to be a case of rhabdomyolysis, it is a very rare side effect with all statins — less than one case in 10,000 patients," Denney says. "Approximately 10 percent of these one-in-10,000 cases are reported as fatal for all statins (search). The documentation of one such death for Crestor must be understood in the context that there are more than 14 million Crestor prescriptions in over 4 million patients."

Public Citizen's Sidney Wolfe, MD, is less sanguine about the existing data. Wolfe says Crestor is linked not just to rhabdomyolysis but to direct kidney damage.

"This drug causes primary renal failure. It is the only statin that does so," Wolfe told WebMD in a May 2004 interview. "Most of the cases are very low dosage. No other statin does this — it is uniquely dangerous. It is competing with Baycol in terms of a large number of cases of rhabdomyolysis shortly after the drug went on the market."

John P. Cooke, professor of medicine and director of vascular medicine and biology at Stanford University, says Public Citizen is doing a good job of making people aware of potential drug hazards. But in a May 2004 interview, he said it was too soon to say that Crestor is particularly dangerous. Fortunately, clinical trials will soon provide more information.

"It is too soon to knock this drug off the market," Cooke told WebMD. "It has the potential to save lots of lives. So let's go forward with these clinical trials and see what the answer is."

By Daniel J. DeNoon, reviewed by Brunilda Nazario, MD

SOURCES: Emily Y. Denney, spokeswoman, AstraZeneca. John P. Cooke, professor of medicine and director of vascular medicine and biology, Stanford University, interviewed May 18, 2004. Sidney M. Wolfe, MD, director, Public Citizen Health Research Group, interviewed May 18, 2004.