Crestor® and Healthy Hearts

When the U.S. Food and Drug Administration (FDA) last year approved the use of Crestor® (rosuvastatin) to prevent heart attacks or strokes in healthy people, some experts disagreed with the agency’s decision.

"It’s a good thing to be skeptical about whether there may be long-term harm from healthy people taking a drug like this," Dr. Mark A. Hlatky, a professor of health research and cardiovascular medicine at the Stanford University medical school told the New York Times.

Recently published data indicate that statins, a category of drug that includes Crestor®, might increase someone’s risk of developing Type 2 diabetes by 9 percent. While the FDA acknowledged this risk, it still approved the new use for Crestor®. The agency is requiring that this risk information be added to the drug label.

FDA Approval for Crestor®

The FDA approved Crestor® (rosuvastatin), the blockbuster cholesterol-lowering medication, for use in patients with no history of heart disease but who met certain criteria. These patients can be identified by a blood test called high-sensitivity C-reactive protein or CRP.

Under the new FDA guidelines, men over 50 and women over 60 with high levels of CRP are eligible to take Crestor®, even though they have no history of heart disease. Some researchers and doctors dispute the validity of using a test for CRP to predict heart and blood vessel problems.

The FDA approved the new use for Crestor® based on a clinical trial which studied almost 18,000 people who had low cholesterol and elevated CRP levels. The inventor of the CRP test, Dr. Paul M. Ridker, a professor of medicine at Harvard and a cardiologist at Brigham and Women’s Hospital in Boston, was funded to conduct the study by AstraZeneca, the manufacturer of Crestor®.

Crestor® doesn’t go off-label (that is, lose its patent protection) until 2016. The patient population eligible for taking Crestor® under the new FDA criteria is thought to be about 6.5 million people. About 40 million people already took statins for high cholesterol before this 6.5 million group of people was added.

Crestor® sales reached $4.5 billion in 2009. The medication, taken as a daily tablet, sells for a minimum of $3.50 a day.

Crestor® Side Effects Affect Health

Besides the more recently found risk of diabetes among patients taking Crestor®, side effects can include:

  • Constipation
  • Weakness
  • Headache
  • Nausea
  • Muscle pain

Serious risks associated with Crestor® include:

  • A dangerous muscle condition that can lead to kidney damage; symptoms include muscle weakness, pain and tenderness
  • Liver damage
  • Possible damage to the heart, including cardiomyopathy

If you are suffering from what you believe is a side effect of Crestor® (rosuvastatin), we may be able to help you. We will evaluate your circumstances in a free case review to determine if we believe you have a legitimate claim. Contact a Crestor® attorney for more information today.