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Prozac Truth Sarafem
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The
FDA allowed 38 percent of the approval board to have direct ties to Eli
Lilly. Why? Sarafem is Prozac. Is it worth the risk? |
Report medication side effects to the FDA. Click here (Opens New Browser) There is an alternative to Sarafem (Prozac) Click Here PMDD is an unofficial "mental disorder." Unlike the recent Eli Lilly advertisements, a women must experience five or more symptoms before the diagnosis can be made. Eli Lilly is trying so hard to come up with another drug winner to replace Prozac in August 2001, when their patent on Prozac expires, they are exhibiting obsessive-compulsive-disorder in their efforts! PMDD symptoms are:
If you are thinking of taking Sarafem for PMS - PMDD, please first click here and read what side effects are associated with this medication and then decide if it is worth it or not. New labeling for Sarafem ordered by the FDA
For Sarafem labeling - Female Sexual Dysfunction with SSRIs—Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a mood-related disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that selective serotonin reuptake inhibitors (SSRIs) can cause such untoward sexual experiences. Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling, are likely to underestimate their actual incidence. For example, in women (age 18-45) receiving fluoxetine for indications other than PMDD, decreased libido was seen at an incidence of 4% for fluoxetine compared to 1% for placebo. There have been spontaneous reports in women (age 18-45) taking fluoxetine for indications other than PMDD of orgasmic dysfunction, including anorgasmia.
Associated with Discontinuation in US Placebo-Controlled Clinical Trials (excluding data from extensions of trials) - Text added at end of
subsection - Male and Female Sexual Dysfunction with SSRIs--Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that SSRIs can cause such untoward sexual experiences. Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance, cited in product labeling, are likely to underestimate their actual incidence. In patients enrolled in US depression, OCD, and bulimia placebo-controlled clinical trials, decreased libido was the only sexual side effect reported by at least 2% of patients taking fluoxetine (4% fluoxetine, < 1% placebo). There have been spontaneous reports in women taking fluoxetine of orgasmic dysfunction, including anorgasmia. There are no adequate and well-controlled studies examining sexual dysfunction with fluoxetine treatment. Priapism has been reported with all SSRIs.While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects. November 3, 1999 the FDA met with representatives of Eli Lilly to discuss and vote on the approval of Fluoxetine Hydrochloride (Prozac) for the use in treating Premenstrual Dysphoric Disorder. (PMDD) Committee Member with ties to Eli Lilly Robert
Hamer PH.D. A waiver was granted to Robert Hamer. Robert Hamer has financial ties with Eli Lilly. Carole A.
Tamminga M.D.
(Chairman of the Committee)
Andrew
Winokur M.D. PH.D. Carole and Andrew acknowledged for the record they have interest in Eli Lilly but they are not viewed as financial. Quote from the meeting regarding their potential conflict of interest. "The agency has determined, notwithstanding these interest, that the interests of government in their participation outweighs the concern that the integrity of the agency's programs and operations may be questioned." There are a total of 8 Committee Members. 38 % of the Committee consist of people with direct ties to Eli Lilly. It is hard for me to believe that the FDA could not come up with 8 qualified people to evaluate Sarafem. Make no mistake about what Sarafem is. IT IS PROZAC. If you would like to read the transcript of the entire FDA/Eli Lilly meeting click here. A new Browser window will open. The document is in a PDF File.
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