By Rachelle Matherne
Rosuvastatin calcium is a medication sold by pharmaceutical company AstraZeneca under the brand name Crestor. Touted as a “super statin,” it is prescribed to treat high cholesterol and prevent cardivascular disease. The U.S. Food and Drug and Administration (FDA) issued approval for the drug in August 2003, and in the years since, Crestor has been linked to potentially fatal side effects.
Upon its arrival to the market, Crestor was one of the many drugs involved in major direct-to-consumer advertising campaigns. In October 2003, shortly after its European introduction, the editor of medical journal The Lancet, Richard Horton, criticized AstraZenca’s marketing approach for the drug. Horton wrote that the company’s tactics “raise disturbing questions about how drugs enter clinical practice and what measures exist to protect patients from inadequately investigated medicines.” AstraZeneca’s CEO, Sir Tom McKillop, called Horton’s editoral “flawed and incorrect” and “an outrageous critique of serious, well-studied medicine.”
Dr. Whitaker, a physician licensed in California and Washington, led the efforts to convince the FDA to change the labeling of all statin drugs in order to reduce the risk of myopathies, including cardiomyopathy and congestive heart failure.
In May 2002, before Crestor was approved for the U.S. market, Dr. Julian M. Whitaker filed a citizen’s petition with the FDA regarding other statins. Dr. Whitaker, a physician licensed in California and Washington, led the efforts to convince the FDA to change the labeling of all statin drugs in order to reduce the risk of myopathies, including cardiomyopathy and congestive heart failure. Dr. Whitaker maintained that 100-200mg per day of supplemental CoQ10 should be co-prescribed with any statin, as deficiency of the chemical in the blood can contribute to the onset of cardiomyopathy.
The Life Extension Foundation, a non-profit organization involved in anti-aging research, has a long history of challenging the FDA. In the February 2004 issue of the foundation’s Life Extension magazine, one of the organization’s principals, William Faloon, explores potential reasons why Dr. Whitaker’s petition was ignored by the FDA. Faloon writes:
Our opinion as to why drug companies may not want this label change is that it could reduce sales of their statin drugs. After all, if doctors told patients that statin drugs could cause heart muscle degeneration, many cardiac patients would refuse to take this class of drug. There is also an economic issue. Those covered by health insurance often have their prescription drugs subsidized, while government programs provide low-income people with free drugs. If these patients were told they had to buy coenzyme Q10 supplements if they are prescribed a statin drug, many would not be willing or able to bear this extra cost.
The article cites numerous references to support Faloon’s claims.
In 2004, the nonprofit public interest group Public Citizen Health Research Group filed a citizen’s petition with the FDA to ban Crestor. The petition, urging for immediate recall, was addressed to the FDA Commissioner at the time, Dr. Mark McClellan, and signed by Public Citizen director Dr. Sidney M. Wolfe. The petition cited, among other things, the decisions by major U.S. health insurers and the Swedish government not to reimburse for Crestor as proof of the drug’s dangers.
In March 2005, the FDA issued a response to Dr. Wolfe that denied the petition and indicated that Crestor posed no greater threat than other drugs like it. In a 2005 alert, the FDA said that “it does not appear that the risk [of rhabdomyolysis] is greater with Crestor than with other marketed statins.” A product label change about the potential side effect was mandated by the FDA, however, along with a warning to start some patients on lower doses and to screen for certain medical conditions before prescribing.
In the years since, there has still been no FDA recall of the drug. Although there has been no class action lawsuit initiated, there are numerous law firms who are investigating the matter and seem prepared to represent patients who believe they have developed additional health issues as a result of using Crestor.
Source: “Rosuvastatin Calcium (marketed as Crestor) Information,” FDA via WebArchive.org, March 2005
Source: “Petition to Ban Cholesterol-Lowering Drug Rosuvastatin (Crestor),” Public Citizen, 03/04/04
Source: “Citizen Petition To Change The Labeling For All Statin Drugs…” (PDF), FDA.gov, 05/24/02
Source: “The statin wars: why AstraZeneca must retreat,” The Lancet, 10/25/03
Source: “FDA issues warning label for AstraZeneca’s Crestor,” Medical Marketing and Media, 03/03/05
Source: “FDA Updates Crestor Warning Information,” WebMD, 03/03/05
Source: “Cardiologists Overlook Lifesaving Discovery,” Life Extension, February 2004
Source: “FDA rejects Crestor petition,” USA Today, 03/14/05
Image by colros (Sandra Cohen-Rose and Colin Rose), used under its Creative Commons license.