Pfizer Print Advertisement Is Misleading, FDA Says

Pfizer omitted risk information and made unsubstantiated superiority claims about its drug Geodon in a print advertisement, according to an FDA warning letter.

Pfizer should cease disseminating the advertisement as it misbrands the drug, the letter from the FDA’s Division of Drug Marketing, Advertising and Communications said. Geodon (ziprasidone mesylate) is indicated to treat acute agitation in schizophrenic patients.

Geodon’s labeling includes a black box warning for increased mortality in elderly patients with dementia-related psychosis, said the letter, which was sent July 16 and posted to the FDA website Aug. 13. While the print advertisement, which appears in a professional journal, contains this warning, other warnings are insufficiently presented, the agency added.

The drug’s labeling also has warnings for neuroleptic malignant syndrome, tardive dyskinesia, and hyperglycemia and diabetes, the letter added. However, the advertisement in the journal lacks these warnings.

In addition, the advertisement does not include precautions for rash, orthostatic hypotension and seizures. “The journal ad misleadingly suggests that Geodon for Injection is safer than has been demonstrated,” the letter said.

The FDA requested a response by July 27. “We take compliance of promotional rules and regulations very seriously, and took the necessary action outlined in the guidance which came from the FDA,” a Pfizer spokesman said.