AstraZeneca Cautions Doctors on High Dose Crestor
Mon May 17, 2004 05:39 PM ET
By Mark Potter and Ben Hirschler
LONDON (Reuters) - 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 a condition that can lead to kidney damage.
The company said on Monday it had told health-care 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 -- muscle toxicity that can lead to kidney damage -- 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.
AstraZeneca shares fell 1.57 percent in London trading.
In the United States, consumer group Public Citizen renewed its call for Crestor to be banned.
The group said it had obtained new data showing that seven U.S. patients who were taking the 10 mg dose experienced rhabdomyolysis.
Industry analyst Craig Maxwell of JP Morgan said Crestor's rhabdomyolysis rate did not appear unduly alarming and he saw no reason to change his global sales forecast for the product of $3.5 billion by 2008.
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.
Morgan Stanley analysts also noted there had been no rhabdomyolysis-related fatalities with Crestor, in contrast with Baycol, and the U.S. Food and Drug Administration -- guardian of the world's biggest drug market -- was comfortable with the drug's safety profile.
News of a handful of rhabdomyolysis cases in Britain may not help AstraZeneca in negotiations with German officials, however. Germany has yet to agree the wording of Crestor's label because of lingering worries among regulators about its safety.
AstraZeneca Chief Executive Tom McKillop told Reuters earlier this month he still hoped Crestor would go on sale in Europe's biggest drug market but he was ready not to launch in Germany if the label and price were not right.
(Additional reporting by Alison Tudor in London and Lisa Richwine in Washington)