Healthy Skepticism Library item: 11195

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Pfizer gets warning from FDA over misleading Gedeon ads
Pharma Times 2007 Aug 14
http://www.pharmatimes.com/WorldNews/ViewArticle.aspx?id=11514http://

Notes:

See also HS Library Reference No. 11882:
http://healthyskepticism.org/library/ref.php?id=11882

Full text:

An advert for the injectable version of Pfizer’s schizophrenia drug Geodon has fallen foul of US regulators and the firm has been forced to pull the misleading item.

The US Food and Drug Administration has taken exception to an unnamed “professional journal advertisement” for Geodon (ziprasidone) and the agency’s Division of Drug Marketing, Advertising, and Communications has reported that “this piece is false or misleading because it omits important risk information and contains unsubstantiated superiority claims”.

Regarding the former point, the DDMAC noted that while the journal ad
discusses the boxed warning on Geodon, sold elsewhere as Zeldox, 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 for neuroleptic malignant syndrome, tardive dyskinesia, hyperglycaemia and diabetes mellitus. The ad also does not include important precautions, specifically rash, orthostatic hypotension, and seizures and by omitting these risks, it “misleadingly suggests that Geodon for injection is safer than has been demonstrated”.

The agency also takes umbrage over the claim that Pfizer’s drug has “proven advantages” over the intramuscular version of the antipsychotic haloperidol. This “has not been demonstrated by substantial evidence or substantial clinical experience,” said the FDA, and “the single study cited for this claim was an open-label study, which is not an appropriate study design to evaluate subjective endpoints”. In fact, the FDA told Pfizer in a letter that “if you have data” to back the claim “please submit them.”

The DDMAC concluded by saying that “the violations discussed in this letter do not necessarily constitute an exhaustive list” and told Pfizer to “immediately cease the dissemination of violative promotional materials for Geodon”. The New York-based drugs giant responded quickly and a spokesman noted that “we take compliance of promotional rules and regulations very seriously and took the necessary action outlined in the guidance which came from the FDA’‘.

Gedeon is a big earner for Pfizer and sales in the second quarter were up 8% to $178 million.