WEDNESDAY, Aug. 13 (HealthDayNews)-- Only a month after getting a government advisory committee's go-ahead, Crestor (rosuvastatin) has received approval from the Food and Drug Administration (FDA) to be used to fight high cholesterol.
Crestor, a prescription medication, is in a class of drugs known asHMG-CoA reductase inhibitors (statins).The FDA, in granting its approval, said:
"Rosuvastatin was approved based on multiple trials of at least 6 weeks duration in which Rosuvastatin treatment was compared to placebo and other marketed statins. In these trials, rosuvastatin reduced total-C, LDL-C, and TG and increased HDL-C with therapeutic response occurring within one week and maximum response seen at four weeks. Approximately 12,000 patients received rosuvastatin at different doses in clinical trials submitted to FDA."
Statins work by partially blocking the synthesis of cholesterol in the liver. This, in turn, leads to increased removal of cholesterol from the blood.
The FDA notes that there are other factors that may contribute to the risk of atherosclerosis, hardening of the arteries: high blood pressure, diabetes, smoking, and a family history of early heart attack.
Manufactured by the pharmaceutical firm AstraZeneca, Crestor can cause some side effects, including muscle aches, stomach pain, constipation, nausea, and weakness. The FDA recommends contacting your physician if general muscle aches persist.
Here is the FDA Talk Paper announcing the Crestor approval.