Updated Safety Information for Crestor (May 2005)

FDA recently provided health care practitioners and patients with updated information about the risks and benefits of Crestor (rosuvastatin calcium), a cholesterol-lowering drug made by Astra-Zeneca Pharmaceuticals.

Crestor, like all other statins, has been associated with rhabdomyolysis. The incidence of this effect is low, and the risk of serious muscle damage doesn't appear to be greater for Crestor than for other statins.

But as with all statins, the risk of myopathy increases with higher drug levels. So Crestor's labeling has been changed to re-emphasize the risk of myopathy, particularly at the highest approved dose of 40 mg. The labeling also stresses the need to consider using lower starting doses in some patients.

This may be particularly important when treating Asian Americans, since a large pharmacokinetic study found that this group of patients had drug levels about twice as high as a Caucasian control group, and that could increase their risk for myopathy. The revised labeling now recommends that the 5 mg dose of Crestor be considered as the starting dose for Asian-Americans, and also for others with predisposing factors for myopathy, including patients on cyclosporine and those with severe renal insufficiency.

Category:

Science & Technology

Tags:

• Updated
• Safety
• Information
• Crestor
• Cholesterol-Lowering
• Drug
• FDA
• Statins
• Rhabdomyolysis
• Myopathy
• Asian
• Americans

[tickyul]

I truly believe that statins caused my father to have a stroke. At 75 his doctor said he had some plaque in his arteries (never effected him from what I saw) and prescribed a statin. After that it was all downhill, muscle wasting, weight loss, pain, eventually onto oxygen, amnesia, dementia and eventually a fatal bleeding stroke at 79.

[fairhillnorrie]

thank you. i have recently been on lipitor for cholesterol... then after a holiday my col' went up to 7 so i was put on Crestor.. to be quite honest i overindulged on holiday. my col' before was 4.. but on hols thing went wrong.. i had bad turn.. faint, pins and needles in my face and hands and very bad in my shoulders.. i was GREY in my face with a cold sweat.. blood tests showed i was a heart prob' as i have CHD. and AS. So when i returned home i was put on Crestor. why? thanks a mill'