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 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.
Click here and you will be
directed to The Road Back, which offers all of the information for free on their
Web Site.
Sarafem -
Alert from the F.D.A.
FDA ALERT [07/2005]: Suicidal Thoughts or Actions in
Children and Adults
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
Taking antidepressants may increase suicidal thoughts and actions in about 1
out of 50 people 18 years or younger. FDA has approved Zoloft for use in
children only if they have obsessive-compulsive disorder.
Adults
Several recent scientific publications report the possibility of an increased
risk for suicidal behavior in adults who are being treated with antidepressant
medications. Even before these reports became available, FDA began a complete
review of all available data to determine whether there is an increased risk of
suicidal thinking or behavior in adults being treated with antidepressant
medications. It is expected that this review will take a year or longer to
complete. In the meantime, FDA is highlighting that adults being treated with
antidepressant medication, particularly those being treated for depression,
should be watched closely for worsening of depression and for increased suicidal
thinking or behavior.
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.
News story just released on the Drug
Reaction Test as well, January 25, 2005.
Click here to
read. (Opens new Browser window)
The adverse drug
reactions can be stopped or predicted.
Do you have Sarafem side effects or
a Sarafem story you would like others to read? Your
story does help others.
Click here
to post.
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:
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Markedly depressed mood
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Marked anxiety
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Marked affectivity
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Decreased interest in activities
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Feeling sad, hopeless or self-deprecating
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Feeling tense, anxious or "on edge"
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Persistent irritability, anger and increased interpersonal conflicts
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Feeling fatigued, lethargic or lacking in energy
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Marked changes in appetite
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A subjective feeling of being overwhelmed or out of control
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Physical symptoms such as breast tenderness, swelling or bloating
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.
Associate Professor (Statistician)
Department of Psychiatry
R.W. Johnson Medical School. D-331 UBHC
University of Medicine & Dentistry of New Jersey
Piscataway, New Jersey 08854
A waiver was granted to Robert Hamer. Robert Hamer has financial ties with Eli Lilly.
Carole A. Tamminga M.D.
(Chairman of the Committee)
Professor, Department of Psychiatry
University of Maryland at Baltimore
Maryland Psychiatric Research Center
Spring Grove Hospital, White Building
Baltimore Maryland 21228
Andrew Winokur M.D. PH.D.
Director of Psychopharmacology
Department of Psychiatry, MG1410
University of Connecticut Health Center
10 Talcott Notch Road
Farmington, Connecticut 06032
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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"The Name
Changes, But the Drug Remains the Same: Prozac vs Sarafem
by 9NEWS health reporter Dr. Stephanie Clements |
March 23, 2001
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Mental
health experts want the public to know that new marketing does not a new
drug make. They are especially concerned over the remarketing of Prozac as
Sarafem, frequently advertised as a new treatment for premenstrual
dysphoric disorder.
Several Denver psychiatrists, including Dr. Joanne Ritvo, say the ads
don't make it clear that Sarafem and Prozac are the exact same drug,
fluoxetine (it's chemical name.)
"I presume the company felt like it could get past the stigma, the
bad wrap that Prozac has had over the years, by calling it a different
name. But some women will say, 'what do you mean I'm taking Prozac, I
didn't want to be taking Prozac!, says Dr. Ritvo, who treats a fair number
of women suffering from PMDD.
Ritvo's concerns parallel those of other mental health professionals
interviewed by phone:
1. Women may not realize they're indeed taking an antidepressant, and need
to stay away from alcohol and other medications with harmful interactions.
2. Since very few referrals for counseling/psychotherapy are made these
days, the drug will be prescribed mainly by non-mental health
professionals. Studies show the average interview for mental illness in a
non-specialist's office is about 3 minutes, according to Dr. Ritvo.
Without a thorough history and physical and a lengthy family history of
mental illness, serious predisposition to mental illness like manic
depression (bipolar disorder) may be missed. In those patients
Prozac/Sarafem/fluoxetine can actually trigger manic depression!
3. Patients will get pills, but not counseling. Once they're off the
medication, the problems will likely return. Scientific literature is
abounding with evidence that pills without counseling is not very
successful, short term or long term.
4. The direct advertising campaign sparks patients to diagnose themselves,
then pressure their doctors for the drugs. Dr. Ritvo says it is obviously
a very successful approach for the drug companies, but she worries about
misdiagnoses leading to further illness in those circumstances.
5. The overall tenor of the TV advertising that comes across as promoting
a simple pill to 'cure' a very complicated problem.
6. The drug is the longest-acting antidepressant, staying in the body for
7 to 9 days. That means if a patient is over-stimulated by it, doctors
have great difficulty reversing the effect.
When
prescribed correctly to the appropriate patient, Ritvo says the drug can
go a long ways in treating legitimate depression, some anxiety disorders
and indeed some cases of PMDD. She urges both doctors and patients to be
very careful using fluoxetine."
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