US FDA asks Pfizer to pull "misleading" med journal ad for schizophrenia drug Geodon

The US Food and Drug Administration has asked world drug giant Pfizer to stop running a medical journal advertisement for its schizophrenia drug Geodon (ziprasidone) on the grounds that it omitted important safety information and claimed it was better than another medicine.

According to the agency's Division of Drug Marketing, Advertising and Communications (DDMAC), while the advert discusses the boxed warning for increased mortality in elderly patients with dementia-related psychosis, the warning for QT prolongation, and a list of the most commonly-observed adverse events, it fails to communicate other serious warnings and precautions associated with the use of Geodon for injection.

Specifically, the advert failed to include warnings for neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia and diabetes mellitus, the FDA noted, adding that, while "movement disorders" and "low EPS," are mentioned, this is insufficient to communicate the risk concepts associated with tardive dyskinesia. Additionally, the advert 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," stated the agency's warning letter.