Various Topics on Medicine - Cardiology

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Cholesterol drug faces new regulation

"It will come off the market; it's just a matter of how many people
will be injured or killed before it does."

European officials change AstraZeneca's Crestor label
By Kristen Gerencher, CBS.Marke****ch.com


SAN FRANCISCO (CBS.MW) -- European regulators strengthened labeling
requirements on AstraZeneca's cholesterol-lowering drug Crestor this
week due to concerns about a rare side effect.

The new label is to tell doctors in the 22 European Union member
countries to start all patients on the 10-milligram dose instead of
higher doses for an initial four-week trial, according to the Dutch
Medicines Evaluation Board, which approved the drug in Europe.

Crestor, also known as rosuvastatin and part of the popular statin
family of anticholesterol drugs, has caused concern amid some reports
of rhabdomyolysis --severe muscle toxicity that can lead to kidney
damage.

The agency also called for revising package labels to advise
restricting use of the high-dose 40 milligram prescription to patients
who have no risk factors for muscle toxicity, something that should be
determined by specialists.

Shares of AstraZeneca fell 21 cents to close at $47.45 Thursday.

Last month, the company sent a "Dear Doctor" letter to British
physicians, warning them to adhere to prescribing guidelines and avoid
starting patients at higher doses.

"There were some inappropriate prescription patterns in Europe where
physicians were starting out patients on the 20- or 40-milligram"
version, AstraZeneca (AZN: news, chart, profile) spokesman Gary Bruell
said.

The U.S. Food and Drug Administration, which approved Crestor for U.S.
consumers in August 2003, issued a public health advisory in response
to the European regulators' move.

The FDA reiterated that doctors need to "carefully read the Crestor
product label and follow the recommendations for starting doses, dose
adjustments and maximum daily doses to minimize the risk of [muscle
damage] in individual patients," according to the agency's Web site.

AstraZeneca stands behind the drug's safety, according to Bruell. "We
have data continuing in over 2 million patients in 5 million
prescriptions, and the safety profile continues to be similar to all
the other marketed statins. The FDA has monitored this product very
closely and [is] in agreement."

Bruell declined to reveal how much the company is paying to market
Crestor, a competitor to more established statins such as Pfizer's
market-leading Lipitor, which accounted for $9.2 billion in sales last
year. Sales of Crestor could be crucial to AstraZeneca to offset
losses from a patent expiration on Losec, its ulcer medication.

In 2001, the FDA removed Bayer's statin Baycol from the market after
more than 100 people died from complications.

But Baycol never showed problems prior to FDA approval, unlike
Crestor, which produced several cases of rhabdomyolysis before winning
the agency's approval, according to Dr. Sidney Wolfe, health research
group director for Public Citizen, a U.S. consumer group.

What's more, there are now seven new cases in the United States among
those who used Crestor at the low-dose 10 milligram level, Wolfe
indicated.

"Things are really boding poorly for this drug. It should never have
been approved," he said. "It will come off the market; it's just a
matter of how many people will be injured or killed before it does."

In March, Public Citizen petitioned the FDA to take Crestor off the
market.


Kristen Gerencher is a reporter for CBS.Marke****ch.com in San
Francisco.