Crestor Warnings Not Strong Enough?

March 14, 2005

Friday, Mar 11, 2005 11:24 AM • Permalink

You may recall an blog I posted last week about this long-overdue

warning from the FDA about Crestor that it may cause an increased risk

of potentially life-threatening muscle damage, particularly among

those of Asian ancestry. Even more maddening: The FDA knew about the

risk they regarded a " small one " two years ago.

Public Citizen, the consumer group founded by Ralph Nader, sent a

letter yesterday to FDA's Lester Crawford, blasting the agency for

what it believed to be a severe understatement of Crestor's risks in

addition to calling for its removal from the market.

Their analysis of adverse reactions over 12 months found Crestor was

linked to the dangerous muscle condition rhabdomyolysis (a risk voiced

by my hero Dr. David Graham) some six times more than any other statin

being sold. Based on adverse-event information submitted to the FDA

from patients, doctors and drugmakers, the incidence of muscle damage

due to Crestor was 13.1 per million prescriptions.

Another tweaking of the numbers may show why AstraZeneca may be

fighting behind the scenes to keep Crestor on the market. Although

Crestor lags way behind Lipitor and Zocor, U.S. sales amounted to more

than $600 million in 2004, an increase of more than 1,000 percent,

from its debut the year before.

Just another reminder, the best way to treat high cholesterol isn't

with a drug that could potentially do great harm. Two primary

strategies that work well over 99 percent of the time if properly

implemented.

* Daily cardiovascular exercise

* Low grain diet

USA Today March 11, 2005

PublicCitizen.org March 10, 2005

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