Sarafem (Prozac)

If you are suffering from Sarafem side effects or Sarafem withdrawal side effects, there is an answer and a solution.

The common Sarafem side effects of anxiety, insomnia, weight gain, or unwanted head feelings can usually be handled quickly.

Whether you want to taper completely off Sarafem or just eliminate the existing side effects caused by the medication, there is an answer and a solution.

Sarafem - Alert from the F.D.A.

Patients with depression or other mental illnesses often think about or attempt suicide. Closely watch anyone taking antidepressants, especially early in treatment or when the dose is changed. Patients who become irritable or anxious, or have new or increased thoughts of suicide or other changes in mood or behavior (or their care givers) should contact their healthcare professional right away.

Children

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

Report medication side effects to the FDA. Click here (Opens New Browser)

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:

• Markedly depressed mood

• Marked anxiety

• Marked affectivity

• Decreased interest in activities

• Feeling sad, hopeless or self-deprecating

• Feeling tense, anxious or "on edge"

• Persistent irritability, anger and increased interpersonal conflicts

• Feeling fatigued, lethargic or lacking in energy

• Marked changes in appetite

• A subjective feeling of being overwhelmed or out of control

• Physical symptoms such as breast tenderness, swelling or bloating

New labeling for Sarafem ordered by the FDA

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.

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