These statements, isolated out of context by bulleting, headlining, or other means, are misleading because they suggest that Geodon is safer than has been demonstrated by substantial evidence.  The Indications and Usage section of the approved product labeling (PI) for Geodon states that ziprasidone has a "greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs" and that this effect "is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death.  Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known." Furthermore, the bolded warning of the PI discusses the concern regarding QT prolongation, torsade de pointes, and the risk of sudden death, including the fact that although torsade de pointes has not been observed in pre-marketing studies, "experience is too limited to rule out an increased risk,"

In addition, the bolded warning emphasizes the uncertainty regarding the ECG profile that may result from treatment with Geodon, as the association of QT prolongation and sudden death resulting from torsade de pointes is difficult to observe.  Finally, the claim that post-marketing experience is consistent with the clinical trial database implies that there is no risk of torsade de pointes and sudden death with Geodon when, in fact, data are very limited.  Pre-marketing and post-marketing exposure is insufficient to allow a conclusion that torsade de pointes will not occur.  Further, FDA has received several spontaneous reports of QT prolongation greater than 500 cosec, all indicative of a potential risk of this arrhythmia.  There are also reports of sudden death where the cause of death is not known, but could represent torsade de pointes even if unrecognized.  In sum, it is premature to conclude that Geodon does not present any risk of torsade de pointes.

The brochure ID# GZ102859 presents these statements in the center of the back page (see also page 12) under the blue headlines "A well-characterized ECG profile" and "Postmarketing experience."  A bolded paragraph regarding the association of QT prolongation and torsade de pointes in other drugs is found at the bottom of the page.  Although this paragraph correctly acknowledges that Geodon has a greater capacity to prolong the QT interval than several antipsychotics, it states that "in some other drugs" QT prolongation has been associated with torsade de pointes, implying that this is not a concern with Geodon.  There is no mention that there is a specific concern with Geodon because the pre-marketing experience and post-marketing experience to date is too limited to rule out this risk.  Thus, this presentation is misleading because it claims that there is no torsade de pointes when this has not been demonstrated by substantial evidence and because it fails to accurately disclose the risk.

The brochure ID# GZl02857 focuses on the effects of Geodon on the ECG profile and prominently displays the misleading statements listed above. The overall presentation of the four-page brochure minimizes concerns regarding Geodon's effect on cardiac arrhythmia and sudden death.  In addition, the risk information is not presented with a prominence and readability that is reasonably comparable to the presentation of how "well-characterized" the ECG profile is for Geodon.  Finally, the brochure fails to communicate that experience with Geodon is too limited to rule out the risk of torsade de pointes and sudden death.