Sept. 16, 2003
Public Citizen Warns Against New Statin Drug Crestor
Cholesterol Drug Potentially More Dangerous Than Baycol; FDA Should Not Have Allowed on Market
WASHINGTON, D.C. – Patients should not take the newly approved cholesterol drug, rosuvastatin, which AstraZeneca will sell under the name Crestor, because it has a significant potential to cause kidney damage and failure, as well as muscle destruction (rhabdomyolysis), Public Citizen’s Health Research Group said today. The U.S. Food and Drug Administration (FDA) approved the drug on Aug. 13 and it is just now becoming available by prescription.
Public Citizen will issue a "Do Not Use!" warning about Crestor in the October issue of Worst Pills, Best Pills News, an online service and monthly newsletter that contains information on drug safety and effectiveness, dangerous dietary supplements, drug-induced symptoms and drug interactions. Although the site, www.worstpills.org, usually requires that users subscribe to read its articles, the full text of the warning on Crestor was posted today at no charge because of the serious danger that Crestor users may face.
Public Citizen made a formal presentation to an FDA advisory committee in July, strongly opposing the drug’s approval based on its unique kidney toxicity (click here to view). The drug was approved on the condition that it be available only in five, 10 and 20 milligram strengths, with restricted distribution of a 40 milligram dose. Such restrictions, however, will not adequately protect patients.
"It was irresponsible of the FDA to approve this drug without requiring routine urine testing for protein and blood to monitor for the early signs of kidney damage, " said Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group. "This drug is already showing signs that it is too dangerous for people to take, and it is only a matter of time, after ‘enough’ people have been injured or killed, that it will have to be pulled from the market."
In studies before its approval, seven people were struck by cases of rhabdomyolysis, an adverse reaction involving the destruction of muscle tissue that can lead to kidney failure. Baycol, another statin, was removed from the market in the fall of 2001 after at least 31 reports of fatal rhabdomyolysis. For more than three years before it was banned, Public Citizen warned patients not to use Baycol. Even so, Baycol did not show life-threatening rhabdomyolysis in pre-approval clinical trials. Crestor is the only statin to have the reaction arise before its approval.
In addition to the risks of kidney damage, patients should avoid Crestor because it has not been shown to reduce the risk of heart attacks and strokes, which is a benefit of lower cholesterol levels. Three other statins – lovastatin, pravastatin and simvastatin – have shown such a benefit.
In the past, Public Citizen’s Do Not Use! warnings have preceded safety-related withdrawals of drugs such as Baycol, Propulsid and Rezulin by months, sometimes years. The Health Research Group has listed more than 200 drugs as Do Not Use! during the past 15 years.
Click here to read the article warning readers to not take rosuvastatin on the Worst Pills, Best Pills site; although non-subscribers will be able access this particular article, reporters can obtain a complimentary subscription to the full online newsletter by calling the Public Citizen press office.