WASHINGTON (Kyodo) The U.S. Food and Drug Administration warned Wednesday that health risks are higher for Asian people than other racial groups using the cholesterol-lowering drug Crestor.
Crestor was developed by Japan’s Shionogi & Co. and is marketed by Britain’s Astra-Zeneca Pharmaceutical LP.
The finding is likely to call into question the health risks on Japanese as Shionogi has said it used overseas clinical test data in applying for Crestor’s approval in Japan. Its production and sales in Japan were approved in January.
In Japan, a Shionogi spokesman said: “The U.S. Food and Drug Administration took the issue this time of a dosage of 40 mg. In Japan, we have only been authorized to offer up to 20 mg. We don’t think this would pose a major problem.”
The official acknowledged there is little empirical data on the effect of the drug in Japan and said the company will carefully monitor the effects through postsales analysis.
The FDA said in a press statement that clinical trial data taken after the drug went on the U.S. market in 2003 suggest that Asian-American patients “may have higher drug levels and therefore be at greater risk for muscle injury due to Crestor than the general population.”
In a separate public health advisory updating the risks and benefits of Crestor, the FDA said the study on a diverse population of Asians residing in the United States has found that drug levels for the Asians were about twice as high as for Caucasians.
Crestor, genetically called rosuvastatin calcium, is a new family of the cholesterol-lowering statins, which are all known to carry a rare adverse effect of serious muscle damage.
A group monitoring problems of approved drugs has been urging the FDA to stop Crestor, claiming it has higher health risks, including kidney failure, than other statins.
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