Smoking Gun Documents: SSRI (Selective Serotonin Reuptake Inhibitor) Dangers
Early, Ominous Warning on Prozac
- March 1985: Three years before Prozac was approved the FDA, Dr. Richard Kapit reviewed the drug and found it generally safe but warned it posed a risk of worsening "vegetative aspects of depressive illness" for some patients. He noted that out of 1427 exposures "there were two completed suicides" and “13 patients who attempted suicide.” He stated that "it may be appropriate" to include a "warning" on the label "that certain signs and symptoms of depression may be exacerbated by this drug."
FDA Officials 'Friendly' With Drug Manufacturer
- October 1986: This memo recounts, from the point of view of drug maker Eli Lilly, a conversation between FDA employee, Tony DeCiccio, and Lilly representatives. The memo states that Lilly "has a friend in Dr. (Robert) Temple." Temple was a senior FDA official.
- July 1990: A flurry of emails on July 18, 1990 reveals a close and cooperative working relationship between Lilly's chief scientific officer presiding over the approval of Prozac, Leigh Thompson, and Dr. Paul Leber, an FDA official. The two men were on the phone at 6:15 a.m. discussing their concerns about media curiosity about the link between Prozac and suicidal thoughts.
FDA Contradicts Itself
- July 1990: Dr. Leber, in an internal FDA memo dated July 18, said he "trashed" the idea of a particular link between Prozac specifically and suicidal thinking during an interview with a reporter.
- September 1990: FDA epidemiologist, Dr. David Graham warns that Prozac studies by Lilly excluded patients who had known suicidal inclinations. He reexamined data and found "Treatment-emergent suicidality" was more than three times as frequent among patients given Prozac than those given tricyclics, an older class of antidepressant.
Teaming Up to Mislead Patients
- September 1990: Lilly executives, worried that a link between Prozac and suicidality would lead to a labeling change on the medication, exchange strategy ideas developed in part through discussions with Dr. Leber of FDA, whom one describes as "our defender."
- October 1990: A memo from Glaxo-Smith-Kline recounting a conversation with FDA Medical Officer, Dr. Martin Brecher about reports linking paroxetine/Paxil to suicidal and violent thinking noted Brecher dismissed the controversy as "a public relations problem" but "it needs to be addressed."
Even Drug Executives Express Surprise at FDA's Lax Standards
- November 1990: SmithKline memo notes that FDA advisory committee recommended approval of sertraline even though it had a "very weak package in support of it."
- February 1991: A note between Pfizer executives expresses surprise that FDA, unlike European regulators, shows little concern that Prozac compares weakly to placebo in efficacy trials. "I find it odd that FDA not at all questioning [sic] efficacy and there are significant questions raised by several European companies."
International Regulators Far Stricter
- April 1991: A lengthy Pfizer memo notes that throughout Europe Zoloft had "received an unfavorable review." Pfizer worried "lack of approval [in Germany and France] will have devastating consequences on the commercial potential of sertraline internationally." The memo recommended new studies "designed to enhance the probability of success."
FDA Official Endorses Drug Despite Safety Problems
- August 1991: Dr. Paul Leber files a memo endorsing approval of sertraline, under the trade name Zoloft, even though the evidence of efficacy "is not as consistent or robust as one might prefer it to be."
Health Problems, Warnings Mount
- March 2004: FDA issues a public health warning instructing manufacturers of antidepressant drugs to include in their labeling a warning statement that recommends close observation of adult and pediatric patients treated with these agents for worsening depression or the emergence of suicidality.
- October 2004: FDA issues a second public health warning to highlight the possibility of worsening depression symptoms and suicidal thoughts associated with some antidepressant medications.
- December 2004: Working Group of the Committee on the Safety of Medicines Report concludes that the use of all SSRI medications, except Prozac, was not advisable for children under 18. The report stated that among children and adolescents treated with SSRI’s there was "an increased rate…of insomnia, agitation, weight loss, headache, tremor, loss of appetite, self-harm and suicidal thoughts" among children prescribed SSRI drugs versus those receiving placebo.