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Why Did the FDA Impose a Black Box Warning on Actos?

The U.S. Food and Drug Administration (FDA) has imposed a black box warning on Actos (pioglitazone). Why? Because although the risks associated with Actos are relatively mild for short-term patients, long-term patients face a distinctly different – and more dangerous – risk profile.


French and German health officials, noting the dramatically increased risk of bladder cancer for patients using Actos for longer than one year, have recommended that their governments remove this powerful Type 2 diabetes medication from the market. In the United States, Actos remains available. However, some patients remain so tragically and unjustly under-informed about the risks this medication may impose that they may have the basis for a lawsuit if they’ve experienced physical harm.


Want to find out more information about the risks associated with Actos and the way that those risks may give rise to legal liability? The attorneys at Fears Nachawati can answer your questions and guide your thinking about what to do next. For your free consultation, call us at 1.866.545.8364 or email We’re ready to fight for you.

Drug Litigation

Why Did the FDA Impose a Black Box Warning on Actos?