September 8, 2011
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Mounting concerns over Actos safety
For almost 10 years, worldwide concerns have escalated regarding the serious complications and side effects pioglitazone may cause:
- 2002: The FDA begins a ten-year epidemiological study designed to evaluate the risk of bladder cancer associated with the use of this drug.
- 2007: The FDA issues a “black box” warning about the serious risk of adverse cardiovascular events, including heart attack, heart failure, and cardiovascular-related deaths.
- August 2011: The FDA informs the public that it updated Actos drug labels to include safety information regarding the increases risk of bladder cancer.
- Actos is now banned in both France and Germany. The European Medicines Agency (EMA) issued warnings about the increased cancer risk.
Moderator Instructions
W. Roger Smith, III, AL
History of Actos
Hunter J. Shkolnik, NY
Recent Studies and Regulatory Action
Dawn M. Chmielewski, OH
Status of Current Litigation
Richard J. Arsenault, LA
Venue Considerations
Stacy K. Hauer, MN
Questions and Answers
