Crestor Side Effects: Reports to FDA MedWatch Analyzed by Tufts Doctors
Crestor-Rhabdomyolysis Link: New Study May Support Allegations by Public Citizen Group
Rhabdomyolysis, proteinuria, nephropathy, and kidney or renal failure are serious side effects which apparently occur more often with the use of Crestor (rosuvastatin) than with other leading cholesterol drugs known as statins. Moreover, when serious side effects did occur, they tended to be within the first three months of Crestor use and not necessarily associated with higher dosages of Crestor. This analysis comes from a new study done by researchers affiliated with Tufts University School of Medicine and the Tufts-New England Medical Center. The new analysis supports the mounting concern about the relative safety of Crestor at the range of dosage levels commonly prescribed to patients in the U.S. Intererstingly, this analysis seems to challenge a recent U.S. Food and Drug Administration decision related to the Crestor's safety, and certainly runs contrary to recent safety claims by AstraZeneca, the manufacturer of Crestor.
In March 2005, the FDA had contended Crestor's side effect risks were no greater than the other statins available for use in the U.S., and it rejected consumer efforts to have Crestor pulled from the market. Instead, the FDA ordered AstraZeneca to put a stronger warning on the Crestor label, which now states that Crestor could cause serious muscle problems and kidney damage, especially among Asians.
The lead researcher for this new study is Richard Karas, director of the preventive cardiology at Tufts-New England Medical Center in Boston. The Tufts study was published May 24, 2005 on an expedited basis by the American Heart Association's journal Circulation by making it available online before the print version was available. An abstract of this new Crestor study can be viewed by use of this link:
For this Crestor study, the Tufts researchers analyzed adverse event reports (AERs) regarding alleged Crestor serious side effects which had been sent to the FDA MedWatch program for the first year that Crestor was available for use in the U.S. The primary analysis examined MedWatch reports concerning Crestor AERs of rhabdomyolysis, proteinuria, nephropaty, and renal or kidney failure. Secondary analyses by the Tufts researchers examined ohter categories of Crestor AERs, including adverse events with serious outcomes, liver toxicity, and muscle toxicity such as myopathy without rhabdomyolysis. In turn, this FDA data was compared to those MedWatch reports of serious side effects made by doctors and patients to the FDA during the same time period for three other statins: Lipitor (atorvastatin), Zocor (simvastatin), and Pravachol (pravastatin). Comparison was also made to adverse events reported to the FDA for the first year of marketing of Baycol (cerivastatin), a statin which was recalled in August 2001 due to an unacceptable high-incidence rate of rhabdomyolysis among patients taking Baycol.
The year after Crestor came on the market in October 2003, more than 5 million prescriptions were filled for the drug. An estimated 20 million Americans are believed to be taking drugs called statins, which researchers say are still the best drugs for lowering high cholesterol and reducing the risk of heart disease and stroke.
An expert and the study's authors agree there were practical, real-world limitations to the new Tufts study. On one side, there is the possible underreporting of Crestor side effects. On the other side, some theorized that the removal of Baycol from the market likely heightened public awareness of safety concerns involving statins, resulting in an increased reporting rate. This situation was summed up by Benjamin Ansell, co-director of the cholesterol treatment program at UCLA medical center in Los Angeles. He acknowledged that is there a general tendency to underreport prescription drug side effects to the FDA; however, there is also a tendency to overreport when controversial prescription drug, like Crestor, has gotten a lot of media attention.
In the wake of this new Crestor safety report being published, the consumer advocacy group Public Citizen announced it would try, again, to get the drug off the market. "This will be further reason to take the drug off the market," said Sidney M. Wolfe, M.D., director of the Health Research Group at Public Citizen. A March 2005 letter by Public Citizen to the FDA regarding Public Citizen's allegation that Crestor has higher rates of rhabdomyolysis compared to other statins can be viewed here:
http://www.citizen.org/publications/release.cfm?ID=7370
- Read more about the Crestor safety controversy
http://www.drug-injury.com/druginjurycom/2005/05/crestor_safety_.html
http://www.druginjurylaw.com/Crestor-information.html
(Posted by: Tom Lamb)
