TABLE OF CONTENTS
Executive summary 5
Introduction 6
Mechanisms of drug withdrawals 6
Recent withdrawals 9
Baycol (cerivastatin) 9
Rezulin (troglitazone) 12
Posicor (mibefradil) 14
The impact of drug withdrawals 17
Changes to the drug approval process 17
Safety investigations 18
Consequences for pharmaceutical companies 20
The future for cardiovascular drug approvals 21
Conclusion 22
Case study: Baycol (cerivastatin) 23
What will be the effect on other statins? 24
Big blow for Bayer but low impact on global statin market 24
Reactions in the US to the withdrawal of Baycol 27
EU review of statins 28
The future for Baycol 29
Appendix 31
Datamonitor's Cardiovascular Business Unit 31
Bibliography 31
Association and company links 32
Further reading 33