Healthy Skepticism Library item: 11193
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
FDA Sends Pfizer Letter Over Geodon Advertisement
PharmaLive 2007 Aug 13
http://pharmalive.com/news/index.cfm?articleID=467447%20&categoryid=9&newsletter=1
Notes:
Link to promotional material:
http://www.fda.gov/CDER/warn/2007/Geodon_Promo.pdf
Full text:
ROCKVILLE, Md., Aug. 13, 2007-Today the FDA posted on its website a letter sent to Pfizer, Inc. regarding an advertisement for Geodon for Injection. The letter is below.
Vice-President, US Regulatory
Pfizer Inc.
235 East 42nd Street
New York, New York, 10017
Fax (212) 672-7807
RE: NDA # 20-919
Geodon (ziprasidone mesylate) for Injection
MACMIS ID # 15144
Dear Mr. Clark:
The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food
and Drug Administration (FDA) has reviewed a professional journal advertisement
(GZ270749A) for Geodon (ziprasidone mesylate) for Injection submitted by Pfizer Inc. (Pfizer)
under cover of Form FDA 2253. This piece is false or misleading because it omits important
risk information and contains unsubstantiated superiority claims. Thus, the promotional
material misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (Act),
21 U.S.C. 352(n) & 321(n). Cf. 21 CFR 202.1(e)(5)(i); (5)(iii); (e)(6)(i); (e)(6)(ii).
Background
According to its FDA-approved product labeling (PI), Geodon for Injection is indicated for the
treatment of acute agitation in schizophrenic patients for whom treatment with ziprasidone is
appropriate and who need intramuscular (IM) antipsychotic medication for rapid control of the
agitation.
Geodon for Injection is associated with a number of serious risks, some of which are
potentially fatal. The PI for Geodon for Injection includes a black box warning concerning
increased mortality in elderly patients with dementia-related psychosis. Furthermore, there
are contraindications and warnings concerning the use of Geodon for Injection in patients
with a known history of QT prolongation (including congenital long QT syndrome), recent
acute myocardial infarction, or with uncompensated heart failure and in patients on
concomitant therapy with other medications that can prolong the QT interval. The QT warning
states that “Some drugs that prolong the QT/QTc interval have been associated with the
occurrence of torsade de pointes and with sudden unexplained death.” The PI also includes
warnings for neuroleptic malignant syndrome, tardive dyskinesia, and hyperglycemia and
diabetes mellitus, as well as a number of precautions including rash, orthostatic hypotension,
and seizures.
- * *
Omission of Important Risk Information
Promotional materials are false or misleading if they fail to reveal facts that are material in
light of the representations made or with respect to consequences that may result from the
use of the drug as recommended or suggested in the materials. While the journal ad
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 Geodon for Injection use. 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.
Unsubstantiated Superiority Claims
Promotional materials are false or misleading if they contain a drug comparison that
represents or suggests that a drug is safer or more effective than another drug in some
particular when this has not been demonstrated by substantial evidence or substantial clinical
experience. The professional journal ad claims:
“ • Proven advantages over haloperidol IM
?twice the improvement as measured on the BPRS”1
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. If you have data, please submit them to FDA for review. Of interest, in the clinical
trials submitted to the NDA for Geodon for Injection, the BPRS was not used and there were
no active comparators.
Conclusion and Requested Action
For the reasons discussed above, the professional journal ad misbrands Geodon for Injection
in violation of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. 352(n) & 321(n).
Cf. 21 CFR 202.1(e)(5)(i); (5)(iii); (e)(6)(i); (e)(6)(ii).
1 Brook S, Lucey JV, Gunn KP, for the Ziprasidone IM Study Group. Intramuscular ziprasidone compared with
intramuscular haloperidol in the treatment of acute psychosis. J Clin Psychiatry. 2000;61:933-941
Robert Clark
Pfizer Inc. Page 3
NDA 20-919
DDMAC requests that Pfizer immediately cease the dissemination of violative promotional
materials for Geodon for Injection such as those described above. Please submit a written
response to this letter on or before July 27, 2007, stating whether you intend to comply with
this request, listing all violative promotional materials for Geodon for Injection the same as or
similar to those described above, and explaining your plan for discontinuing use of such
materials. Please direct your response to me at the Food and Drug Administration, Center
for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and
Communications, 5901-B Ammendale Road, Beltsville, MD 20705-1266, or facsimile at 301-
796-9878. In all future correspondence regarding this matter, please refer to MACMIS #
15144 in addition to the NDA number. We remind you that only written communications are
considered official. If you choose to revise your promotional materials, DDMAC is willing to
assist you with your revised materials by commenting on your revisions before you use them
in promotion.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is
your responsibility to ensure that your promotional materials for Geodon for Injection comply
with each applicable requirement of the Act and FDA implementing regulations.
Sincerely,
{See appended electronic signature page}
Robert Dean, MBA
Regulatory Review Officer
Division of Drug Marketing,
Advertising, and Communications
——————————————————————————————————————————————————————————-
This is a representation of an electronic record that was signed electronically and
this page is the manifestation of the electronic signature.
——————————————————————————————————————————————————————————-
/s/
——————————-
Jialynn Wang
7/16/2007 10:01:12 AM
Signed for Robert Dean, MBA
