Kathi 2012-05-06 05:00:32
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 (that presentation is available on the Web at
www.citizen.org/publications/release.cfm?ID=7262). 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
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.
The article warning readers to not take rosuvastatin is on the Worst
Pills, Best Pills site at www.worstpills.org; 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.
Public Citizen is a nonprofit consumer advocacy organization based in
Washington, D.C. Dr. Sidney Wolfe is author of the best-selling Worst
Pills Best Pills. For more information, go to www.worstpills.org.