New Safety Concerns Over Crestor

June 15, 2004 -- Safety problems with the widely used cholesterol drug Crestor have prompted European regulators to tighten prescription guidelines, but experts warn U.S. physicians may not be fully aware of the potentially deadly hazards for some of the more than 1 million American users of the drug.

Higher doses of Crestor, one of a family of cholesterol-lowering drugs known as statins, could increase risk of myopathy, a potentially life-threatening muscle disease that can affect the heart. In Europe, the drug's maker, AstraZeneca, changed the medication's label to warn doctors of the risk after cases of myopathy were reported there.

AstraZeneca notes these patients were already predisposed to having muscle disease. With the new label, patients who are prescribed Crestor must begin taking the drug at 10 milligrams. Dose increases to 20 milligrams or 40 milligrams — 40 milligrams being the highest dose available — will only be allowed if necessary, such as with patients with severely high cholesterol who are not at risk for muscle disease.

"It really relates to the issue of starting dose," explains Dr. Steven Nissen, vice-chairman of cardiology at The Cleveland Clinic Foundation. "If a person has high cholesterol you start at a higher dose. Now EU [the European Union] says don't ever start Crestor at a higher dose."

In the United States, the Food and Drug Administration is still reviewing reports it has received on the drug's association with muscle disease. But they do not currently have plans to change the U.S. labeling, stating, "these risk factors and many of the recommendations for how to minimize the risk of myopathy are already captured in the FDA-approved label."

Heeding the Warning

Doctors feel that the label change in Europe will affect how they prescribe Crestor. "I will avoid using the 40 milligrams, whereas in the past, I would put them on the top dose available," says Dr. Joe Breault, senior staff physician in Family Medicine at Ochsner Clinic Foundation in New Orleans, La.

Doctors agree side effects can occur with any cholesterol-lowering drug, including statins.