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New Caution On High-Dose Crestor
posted 05/29/04
AstraZeneca Plc has warned British doctors to stick to the
label and not start patients on high doses of new cholesterol drug Crestor
following four cases of kidney damage.
The company said on Monday it had told healthcare professionals in a letter that
patients should not be started directly on the higher 40-mg dose but should be
given 10 mg initially, with doses increasing to 20-40 mg as required. The move
follows four incidents of rhabdomyolysis in 110,000 Britons given the medicine,
said company spokeswoman Kirsty Walker.
That rate of adverse incidents was in line with the side effect profile seen
among competing statin drugs and all the cases occurred after patients were
initiated on a high dose, contrary to the advice on the label, she said. "All
four patients have fully recovered," Walker added.
Concerns about muscle toxicity have overshadowed Crestor and other statins
following the withdrawal of Bayer AG's Baycol in 2001 after it was linked to
more than 100 deaths. But Walker said there was no parallel with the position
with Crestor.
"The Baycol situation was quite different because the rate of rhabdo seen with
Baycol was 20-to 30-fold higher than seen with any of the other statins," she
said.
Source: Diabetes In Control.com.
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