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 March 10, 2005