AstraZeneca's Crestor doubles side effects

By Maggie Fox, Health and Science Correspondent 1 hour, 59 minutes ago

WASHINGTON (Reuters) - AstraZeneca's cholesterol-lowering drug Crestor
has more than double the side effects of rival statin drugs, including
deaths, U.S. researchers reported on Monday.

Adverse effects include muscle damage known as myopathy, including a
severe form known as rhabdomyolysis; proteinuria or protein in the
urine; nephropathy, a reduced ability of the kidneys to filter toxins
from the blood; and kidney failure.

But the American Heart Association, which published the study in its
journal Circulation, said the drug was still generally safe if
prescribed properly and urged patients not to panic or stop taking the
drug.

And AstraZeneca said it strongly disagreed with the study's
conclusions.

Dr. Richard Karas of the Tuft-New England Medical Center in Boston, who
led the study, said his team found a rate of 28 adverse events per
million prescriptions of Crestor, known generically as rosuvastatin.

That was about 2.2 times more than the adverse events seen with
simvastatin, made by Merck and Co. under the brand name Zocor and 6.8
times higher than atorvastatin, made by Pfizer Inc. under the brand
name
Lipitor, he said..

Karas said there were 6 per million deaths on Crestor as compared to 3
per million for Zocor, 1 per million with Bristol Myers Squibb's
Pravachol and 2 per million for Lipitor.

"It would seem prudent at the current time for healthcare providers to
consider other statins as first-line therapy, to initiate therapy in
appropriate patients at lower doses, to consider combination LDL-C
lowering therapy (eg, statin combined with ezetimibe), and to
vigilantly monitor for adverse events if rosuvastatin is used," they
concluded.

REFUSAL TO BAN

"We strongly disagree with the conclusions of this study," the company
said in a statement.

"The study implies that because post-marketing rates of spontaneous
adverse event reports were higher, the risk is also higher. This is
factually incorrect,' it added.

" ... These reports are just that, reports, not medically confirmed
cases."

In March, the U.S.
Food and Drug Administration denied a petition by the consumer group
Public Citizen to ban Crestor, saying it disagreed with arguments that
Crestor was more dangerous than other statins.

For the study, Karas and colleagues looked at adverse events reported
to the
FDA between October 2003 and the end of September 2004.

They broke the data down in several ways but found that overall,
Crestor was associated with many more adverse event reports than its
rivals.

Nonetheless, several heart experts said the drug was safe overall and
should be prescribed for some patients.

"Importantly, most side effects, including myopathy, disappear upon
withdrawal of medication," said Dr. Scott Grundy, director of the
Center for Human Nutrition at the University of Texas Southwestern
Medical Center in Dallas, who wrote a commentary on the report in
Circulation.

Karas said it was important to note that there is no way to prove
Crestor caused the side effects reported to the FDA.

"One of the limitations is that the current surveillance system does
not require the reporting of all the drugs that patients are taking,"
he told reporters in a telephone news briefing.

Crestor is considered a more powerful statin than the others and Karas
and other experts said it may be the only way to get cholesterol down
to desirable levels in some people. But he also noted that 62 percent
of the adverse events were seen at the very lowest dose of the drug.

Statin drugs lower low density lipoprotein or LDL -- the so-called bad
cholesterol that clogs arteries. Patients who take them lower their
risk of heart attacks, stroke and also some cancer such as breast and
prostate cancer, as well as
Alzheimer's disease.

Another statin, Bayer AG's Baycol, was pulled from the market in 2001
after it was linked to more 100 deaths, many of them from
rhabdomyolysis.

Karas said Crestor did not seem to cause as much muscle damage as
Baycol.