Posted by NIM on November 8, 2003, at 19:47:03
The following is an excerpt of a warning letter by the FDA on Geodon..and they want me to give this to my son?!?! He was prescribed this drug without even being seen by the doctor, the only information the doctor had was an intake sheet that an RN filled out after talking with my son and I for about 15 minutes. My son does not hear voices, have hallucinations, strange behavior, etc. The only reason they can give me is "he seems to ramble on in a disconnected way...his thoughts are not in order" This warning letter is not the only scary piece of info out there about this drug. There have been over 100 deaths related to it and legal actions taken over its ability to cause diabetic conditions in people who use it.
Through routine monitoring and surveillance, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has identified promotional materials (GZ102859, GZ102857) for Geodon (ziprasidone HCl) that are in violation of the Federal Food, Drug, and Cosmetic Act and applicable regulations. In addition, DDMAC has identified misleading oral statements regarding Geodon at Pfizer's promotional exhibit booth. at the annual meeting of the American Psychiatric Association (APA) held in Philadelphia, Pennsylvania in May 2002.
Specifically, DDMAC objects to the following claims and representations:
Promotional Materials
Pfizer Inc. (Pfizer) has promoted Geodon in a manner that is misleading and lacking fair balance because it minimizes the important risk information regarding the greater capacity of Geodon to cause QT prolongation, and the potential to cause torsade de pointes-type arrhythmia and sudden death. For example, DDMAC objects to the following claims by Pfizer:
No torsade de pointes
A rare incidence of a QTc interval >500 msec
A well-characterized ECG profile
Postmarketing experience ...
.......consistent with the Geodon clinical trial databaseThese 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,"
poster:NIM
thread:277812
URL: http://www.dr-bob.org/babble/20031105/msgs/277812.html