LONDON (AFX) - AstraZeneca PLC's Crestor anti-cholesterol drug should only be used after every other alternative has failed, according to David Graham, the outspoken government scientist in the US Food and Drug Administration.
In an interview in Saturday's edition the The Independent newspaper, Graham said Crestor has a "unique toxicity", caused by the fact that, in a small number of patients, it has two adverse side-effects: muscle wasting and kidney failure.
For this reason, Crestor should only be used "as a second-line drug when people have failed to respond to other statins", he said.
"Why would you push a drug that you know has potentially a high risk of muscle disease and renal failure when there are other drugs that you know work well?" Graham added.
AstraZeneca strongly rejects Graham's views. Gunnar Olsson, the head of cardiovascular therapies at the company, said Crestor has a "very good efficacy in lowering bad cholesterol and increasing good cholesterol and, at the same time, has a safety profile that is very much in line with all other marketed statins".
He added that other statins - a class of drug used to prevent ailments including chest pain and strokes - also have side-effects which could include muscle wasting and kidney failure.
Crestor has been on the market in the US and UK since 2003. After Dr Graham first told a Senate hearing last year that Crestor was one of five drugs that required further testing, AstraZeneca's share of the anti-cholesterol drug market in the US fell to 6 pct from 8 pct, the newspaper said. AstraZeneca's target for Crestor is nearer 20 pct.
Graham, who works in the FDA's office of drug safety, emphasised his opinion is a personal one and not the official view of the agency, which is still evaluating data being collected now Crestor is on the market.
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In an interview in Saturday's edition the The Independent newspaper, Graham said Crestor has a "unique toxicity", caused by the fact that, in a small number of patients, it has two adverse side-effects: muscle wasting and kidney failure.
For this reason, Crestor should only be used "as a second-line drug when people have failed to respond to other statins", he said.
"Why would you push a drug that you know has potentially a high risk of muscle disease and renal failure when there are other drugs that you know work well?" Graham added.
AstraZeneca strongly rejects Graham's views. Gunnar Olsson, the head of cardiovascular therapies at the company, said Crestor has a "very good efficacy in lowering bad cholesterol and increasing good cholesterol and, at the same time, has a safety profile that is very much in line with all other marketed statins".
He added that other statins - a class of drug used to prevent ailments including chest pain and strokes - also have side-effects which could include muscle wasting and kidney failure.
Crestor has been on the market in the US and UK since 2003. After Dr Graham first told a Senate hearing last year that Crestor was one of five drugs that required further testing, AstraZeneca's share of the anti-cholesterol drug market in the US fell to 6 pct from 8 pct, the newspaper said. AstraZeneca's target for Crestor is nearer 20 pct.
Graham, who works in the FDA's office of drug safety, emphasised his opinion is a personal one and not the official view of the agency, which is still evaluating data being collected now Crestor is on the market.
newsdesk@afxnews.com
jlw
For more information and to contact AFX: www.afxnews.com and www.afxpress.com
© 2005 AFX News
