(April 14, 2012)
Crestor is a high-powered statin drug used for lowering cholesterol levels. The risks associated with Crestor have been known and discussed for a long time, even before Crestor was on the market. Crestor is linked to severe, life-threatening muscle damage, especially in people of Asian ancestry, as reported by the FDA. It seems that the risks of developing side effects from Crestor is much higher than any other statin drug such as Lipitor, Pravachol, or Zocor. The FDA has received more reports of adverse side effects from Crestor than any other statin, (except Baycol, which was removed from the market by the FDA. Bayer, the parent company of Baycol, paid hundreds of millions of dollars in settlements from Baycol cases). Crestor can cause intense muscle damage that can progress into kidney damage and then failure. Crestor can damage the muscles of your body to such an extent that the muscle decays and dies, flooding your bloodstream with toxins. The kidneys cannot handle such a large amount of toxins and substances, and become either severely damaged or failed. Kidney failure usually is fatal. The Washington Post reported that after much criticism, the FDA has issued an advisory warning about the risks posed by the statin Crestor. Sidney Wolfe, of Public Citizen’s Health Research Group, petitioned the FDA to ban Crestor. He said that since the drug came on the market in September, 2003, it has been linked to 117 cases of rhabdomyolysis, and 41 cases of kidney failure, which he said are higher totals than for any other statin on the market. Wolfe called the FDA action “yet another example of the agency’s dangerous cowardice in failing to adequately protect people in this country from uniquely dangerous prescriptions drugs.”
Germany, Norway, and Spain, have not approved Crestor because of these safety concerns. In a formal advisory, the FDA said that the risk of life-threatening muscle damage is small, and was largely identified and understood when the drug was approved in 2003. But due to new post-market studies that underscored the concerns, the FDA concluded that the public should be informed and warning on the label should be strengthened. The advisory, and new instructions to physicians, reflect a recent change in how and when FDA releases potentially troublesome information about a product. After the criticism that the agency did not move quickly enough in communicating possible problems with COX painkillers, including Merck’s Vioxx, FDA officials stated that they plan to give out more preliminary information than they have in the past. “Today’s FDA advisory on Crestor is part of an ongoing effort to notify the public of potentially significant emerging safety data so that they can make more informed choices about their medical care,” said Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research. In their statements, the FDA and AstraZeneca said patients should no longer be started at what had been the highest approved dose of 40 milligrams, but at 20 milligrams. The FDA said that at higher doses, Crestor appeared to cause more bits of protein and blood in the urine, a precursor to possible kidney trouble. In his statement, Wolfe said Crestor is the only statin for which higher doses are linked to a higher rate of these side effects. The FDA also said that in a study of a broad range of Asians, Crestor levels in the blood were found to be twice as high as with white people given the same dosage. Crestor risk signs include muscle aches, tenderness, weakness, fatigue, fever, and dark urine. Crestor risk factors also include liver damage. This risk is increased with Crestor is taken with other medications. Routine blood tests must be done to monitor liver damage when patients are taking Crestor. Crestor side effects include constipation, stomach pain, and nausea. It is recommended that when taking Crestor with other medications, you should check with your pharmacist. Crestor has interactions with many medications, as well as simple antacids, such as Maalox. Crestor risks are higher in patients who are heavy drinkers, Asians and Asian-Americans, and patients with existing liver and kidney problems. If you or someone you know has been affected by Crestor, you may be entitled to monetary compensation from the drug company.