PFPC Daily - March 10, 2005

Crestor warnings too weak, group says

USA TODAY, March 10, 2005

By Julie Appleby

Warnings added to anti-cholesterol drug Crestor last week sharply
understate the drug's risk, the consumer group Public Citizen said
Thursday in a letter to the FDA reiterating its request to have the
drug pulled from the market.

Debate over Crestor is set against a backdrop of growing concern over
drug safety and comes four years after another cholesterol drug,
Baycol, was pulled from the market after being linked to at least 31
deaths from a condition that causes muscle tissue to die.

Public Citizen says its analysis of adverse events reported to the
Food and Drug Administration during a yearlong period ended in
September linked Crestor to that muscle condition, called
rhabdomyolysis, at a rate 6.2 times that of all currently marketed
statin drugs combined.

But AstraZeneca (AZN), which makes the drug, said Public Citizen's
report is based on "unscientific information and incomplete analysis."

Just last week, the FDA approved a new label for Crestor that, while
warning of a higher risk in Asian patients, said the drug's rate of
muscle problems among people using the recommended dosages is similar
to that of other statins. On Thursday, the FDA said it stood by those
comments.

In November, an FDA scientist revived debate over the drug when he
told Congress that it was linked to kidney failure and
rhabdomyolysis, a statement the agency later distanced itself from.

Sales of Crestor, launched in 2003, have been dampened by Public
Citizen's petition in March 2004 for the FDA to withdraw the drug,
and media attention around the congressional hearings into drug
safety.

Still, the drug brought in $908 million in sales worldwide last year,
according to AstraZeneca's annual report. U.S. sales were $608
million, and it ranked fifth in total prescriptions in the statin
drug category, well behind top players Lipitor and Zocor, according
to IMS Health, which tracks the industry.

Physician Sidney Wolfe of Public Citizen says his analysis of
adverse-event information given to the FDA by drugmakers, doctors and
patients shows 13.1 reports of the muscle damage per million
prescriptions of Crestor. All other statins combined had a rate of
2.1 million reports during that same time period.

"Six times higher is not my definition of similar," says Wolfe, a
longtime critic of the FDA.

Still, researchers caution that the data gathered from adverse-event
reports are not definitive because the reports are voluntary, may be
duplicative and are not independently verified. The reports can be
useful, particularly when they spot rare side effects, as warning
flags showing a drug may warrant additional study.