FDA Finds Drugs Associated With Fatal Trial Do Not Pose Safety Risks

The FDA says that drugs under investigation in the U.S. that are similar to one involved in a fatal trial in France are not similarly toxic.

A safety review conducted by the agency in the wake of the disastrous trial of Bial Laboratories’ drug — which killed one participant and led to hospitalization of five others — has determined that the Bial drug candidate exhibited a “unique toxicity” that does not apply to similar drugs undergoing testing in the U.S.

The drug, designated as BIA 10-2474, was evaluated as a potential therapy for mood and anxiety disorders before the Phase 1 clinical trial was closed following the tragedy in January.