FDA Pressed To Ban CrestorJun 25, 2004 | Newsday
A consumer advocacy group yesterday called for a ban on the cholesterol drug Crestor, saying almost 50 people worldwide have experienced serious adverse effects and two people in the United States have died.
The drug's maker, AstraZeneca, insists the medication is safe.
Crestor is the newest member of the class of drugs known as statins, medications that some doctors have dubbed vitamins for the heart because of their effectiveness in controlling the bad form of cholesterol in the blood.
But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group in Washington, D.C., has petitioned the Food and Drug Administration to ban Crestor, saying it can cause serious harm.
Writing in today's issue of the British medical journal The Lancet, Wolfe says Crestor the generic name is rosuvastatin can cause muscle deterioration, a condition known as rhabdomyolysis, as well as kidney failure.
The drug's potential for rhabdomyolysis "is probably higher than the highest of any other currently marketed statin," he wrote.
Primary kidney failure, Wolfe said, occurs when the medication directly damages the organs. Secondary damage occurs, he said, when proteins released during muscle breakdown infiltrate the kidneys.
Other statins include Lipitor, Zocor and Pravachol. Muscle deterioration is a known side effect of any statin, but has been particularly severe with Crestor, Wolfe said yesterday.
"This drug [Crestor] is inherently dangerous and it should not be used," Wolfe said in an interview. "Crestor has unique risks because of its effects on the muscles and the kidneys."
Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, fever, dark urine, nausea and vomiting. In severe cases, rhabdomyolysis can result in kidney failure.
Gary Bruell, spokesman for AstraZeneca, said Wolfe is being alarmist. "Sidney Wolfe continues to make misleading claims based on inappropriate interpretation of the data," Bruell said.
He added that Wolfe's "views are well known and have not changed since the [drug's] approval," Bruell said. "Crestor has a safety profile comparable to that of other marketed statins." The drug was approved in August 2003.
Wolfe's claims and data involving patients' adverse reactions are being reviewed by the FDA.
Last August, Wolfe argued before an FDA panel that the drug should not be approved because muscle deterioration had occurred among people during clinical testing.
Wolfe compared Crestor's performance with that of Baycol, a statin developed by the Bayer Group that was banned in 2001 by the FDA after 31 people died.
Dr. David Orloff, director of the metabolic and endocrine drug products division at the FDA, said in a telephone interview, "There is no evidence that Crestor's label needs to be changed or that there are any safety signals that make Crestor like Baycol."
Bruell added that Crestor "is a totally different molecule."
Although Wolfe's charges come days after Canadian health authorities advised patients to take only the lowest possible Crestor doses, following eight cases of muscle deterioration, Orloff said the Canadians are now making their rules as tight as those in the U.S. Crestor dosages can range as low as five milligrams.
"Crestor is a potent statin. All statins cause muscle injury," Orloff said. "We feel comfortable that [information regarding use on] our label is for safe and effective use."