 |
|
|
This is the sidebar that was originally published with the article, Will British Ban Spur FDA to Act? May 1984: BGA comments - "During the treatment with the preparation (Prozac) 16 suicide attempts were made, 2 of these with success. As patients with a risk of suicide were excluded from the studies, it is probable that this high proportion can be attributed to an action of the preparation [Prozac]. ..." Exhibit 42 (p. 3, sixth paragraph) March 29, 1985: Benefit/risk considerations - "The incidence rate [suicide] under fluoxetine [Prozac] therefore purely mathematically is 5.6 times higher than under the other active medication imipramine. ... The benefits vs. risks considerations for fluoxetine [Prozac] currently do not fall clearly in favor of the benefits. Therefore, it is of the greatest importance that it be determined whether there is a particular subgroup of patients who respond better to fluoxetine [Prozac] than to imipramine, so that the higher incidence of suicide attempts may be tolerable." Exhibit 58 (pp. 18 and 22) June 1986: Draft of proposed "Precaution and Adverse Reactions" sections of the Prozac package insert - "Mania and psychosis may be precipitated in susceptible patients by antidepressant therapy." Exhibit 5 (first page) (never included in actual inserts) August 1989: Additional feedback regarding the fluoxetine [Prozac] review by the Commission A [Germany] - "#3. The counterindication because of acute suicidality should become a warning whereby the physicians should be advised that in the absence of sedation, the risk of higher suicidality, should be taken into account." Exhibit 88. Aug. 3, 1990: Letter to sales representatives regarding reports of suicidal ideation/behavior possibly associated with Prozac therapy - "This information is not intended to replace our current promotional strategy but is being provided to enable you to respond to physicians when appropriate. You should not initiate discussion on these issues nor use this letter in detailing. However, if asked to comment on these issues by a health-care professional, you should: 1. Reassure the health-care professional that no causal relationship has been established between suicidal ideation and Prozac therapy" Exhibit 17 (bottom of first page and top of second page) Oct. 2, 1990: Memo of Lilly employee Leigh Thompson to Lilly employee Robert Zerbe regarding an upcoming Prozac symposium in which the issue of suicidality is discussed - "Then the question is what to do with the 'big' numbers on suicidality. If the report numbers are shown next to those for nausea, they seem small." Exhibit 113 (second page) Nov. 13, 1990: Memo from Claude Bouchy [Lily Germany] to Leigh Thompson Re: Adverse Drug Event Reporting: Suicide Fluoxetine - In response to Lilly's request that he [Bouchy] change the event "suicidal ideation" to "depression," Bouchy writes: "Hans [another Lilly employee in Germany] has medical problems with these directions and I have great concerns about it. I do not think I could explain to the BGA, a judge, to a reporter or even to my family why we would do this, especially on the sensitive issue of suicide and suicidal ideation." Exhibit 117 Nov. 14, 1990: Second memo from Bouchy to Thompson Re: Adverse Drug Event Reporting - Suicide Fluoxetine, in which he states: "I personally wonder whether we are really helping the credibility of an excellent ADE system by calling overdose what a physician reports as suicide attempt and by calling depression what a physician is reporting as suicide ideation." Exhibit 118 1995: Dr. Jick's study, "Antidepressants and Suicide" - "The results indicate that only fluoxetine [Prozac] has a rate that seems to be substantially higher than that of the other antidepressants." Exhibit 155 - KPO FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which
has not always been specifically authorized by the copyright owner. Such
material is made available for educational purposes, to advance understanding of
human rights, democracy, scientific, moral, ethical, and
|