Specifically, the journal ad fails to include the warnings for neuroleptic malignant syndrome, tardive dyskinesia, and hyperglycemia and diabetes mellitus. The journal ad does mention “movement disorders” and “low EPS,” and while we do not object to these claims, the presentations are insufficient to communicate the risk concepts associated with, and the seriousness of, tardive dyskinesia. Additionally, the professional journal ad fails to include important precautions, specifically, rash, orthostatic hypotension, and seizures. By omitting these risks, the journal ad misleadingly suggests that Geodon for Injection is safer than has been demonstrated.The ad made a claim that:
Proven advantages over haloperidol IMTo which the FDA letter said:
―twice the improvement as measured on the BPRS”
This presentation is misleading because it implies that Geodon for Injection is more effective than haloperidol IM when this has not been demonstrated by substantial evidence or substantial clinical experience. The single study cited for this claim was an open-label study, which is not an appropriate study design to evaluate subjective endpoints, such as those measured by the Brief Psychiatric Rating Scale anchored version (BPRS), because of the potential for evaluator bias. In fact, FDA is not aware of any substantial evidence to support this claim.Nice going Pfizer. Keep up the B.S. advertising and the shoddy science (1, 2, 3).