Crestor problems support urgent need for FDA safety reform

Monday, May 23, 2005

Crestor problems support urgent need for FDA safety reform
Washington, D.C. — In response to today’s release of a new study in Circulation, a journal of the American Heart Association, that found elevated and serious risks for Crestor relative to other cholesterol-lowering drugs, Consumers Union called upon Congress to create a strong postmarket safety office within the Food and Drug Administration that would have the authority, funding and independence to investigate and act on such safety risks.
“The public expects the FDA to aggressively investigate safety concerns, but Congress needs to act to make safety a priority,” said Bill Vaughan, senior policy analyst for Consumers Union. “Congress must create a tough postmarket safety office that has both the ability and the will to protect the public health.”
The FDA Safety Act, introduced by Senators Charles Grassley (R-IA) and Chris Dodd (D-CT) and pending before Congress, establishes a new Center for Postmarket Drug Research and Evaluation that is independent of the division that approves drugs. It would be empowered to take action to restrict drug distribution, use and advertising when serious safety concerns arise and require further study of unanswered safety questions.
“The elevated risk of muscle damage from Crestor is not news,” Vaughan said. “Had the Grassley/Dodd bill been the law of the land, FDA could have taken early action to manage the increased risk from Crestor.”
The study’s findings come just two months after FDA made minor revisions to Crestor’s label while assuring healthcare providers that the risks of muscle damage were no greater than for other statins, and nearly a year after the agency promised to monitor the safety of the drug. The study released in Circulation today analyzed adverse event data collected by FDA from AstraZeneca and healthcare providers.
Consumers taking cholesterol-lowering drugs should consult Consumer Reports Best Buy Drugs for more information (www.CRBestBuyDrugs.org) and talk with their doctors about the best treatment for them.
For more information contact: Bill Vaughan, 202.462.6262