Seroquel Dropped From NIMH Funded Study

August 5, 2009 at 1:18 am

   In a letter to the American Journal of Psychiatry, a group of researchers detailed problems with quetiapine (Seroquel) which led to their dropping it from a comparative five year study of atypical antipsychotics. They decided at the recommendation of their Data and Safety Monitoring Board to perform an unplanned analysis partway through that study. The analysis included 294 subjects of a proposed 450 with 61 dropping out of the study.

There were 79 Food and Drug Administration-defined serious adverse events that occurred in 57 of the 233 study subjects while they were taking their randomly assigned drugs. Among the patients taking quetiapine, 38.5% had serious adverse events relative to 19.0% in other groups… All pairwise differences involving quetiapine were significant.

   The letter goes into a fair amount of detail, though brief, stating that duration of treatment was not a significant factor in the adverse events and that occurrences of pneumonia were higher with quetiapine than with other drugs combined. An increased risk of pneumonia may not sound like much, but given the high number of “serious adverse events”,  it seemed noteworthy and realizing that continuing a study would prove too dangerous to complete is certainly a step in the right direction. If only this sort of thing were happening more frequently in the clinical trials for FDA approval.


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