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Flibanserin (Addyi), the Alleged Libido Pill For Women: What Women Need to Know Before Asking for it
September 1, 2015
ppjg Dr Gary Kohls, HEALTH dopaminergic remedy, Dr Gary Kohls MD, FDA, Flibanserin, HEALTH, libido dark medications, serotonin nerves, women’s sex oblige Leave a comment
Duty to Warn
Gary G. Kohls, MD
On August 18, 2015, the FDA proudly announced that they had approved (afterward 2 previous rejections) a new unsalable article whose generic name is flibanserin (Addyi last ~ and testament be the brand name when it comes to your topical drug store in mid-October). The single drug that Sprout Pharmaceuticals has ~more marketed, flibanserin is purported to use a “disease” called hypoactive sexual impulse disorder (HSDD). The drug has been approved alone for pre-menopausal women. The crew will offer the drug in a 100 mg draught, to be swallowed once per obscurity, no matter if sexual encounter is anticipated or not. This pill is not a breeding Viagra!
In a related story, pair days after the FDA’s starched approval to market their only mix with ~s, Sprout announced that it had sold itself to a completely-owned subsidiary of Valeant Pharmaceuticals International, Inc. because $1 billion dollars cash plus a portion of that will be earnings.
Below is some essential background notice about the drug that hasn’t been well covered in the mass media. Every self-seeking patient (and their prescribing practitioners) should understand about this information before they make inquiry for a prescription from their psychiatrist, OB-GYN, internist, line of ancestors physician or nurse practitioner.
Some of the downsides of this renovated, soon-to-be blockbuster drug
For united thing, the drug will be of great price, indeed, it will unaffordable unless hale condition insurance companies can be hood-winked to pay beneficial to it. If they do, look in favor of premiums to rise! Cindy Whitehead, the CEO of Sprout has fixed that it will be charging pharmacies $400 as being a 30 pill supply [which equates to above the top $13 per pill!]. Nobody knows what the mark-up will be at the pharmacy.
Secondly, the put ~s into will very likely be destructive of serotonin nerves pro~ed-term just judging from the corpuscular structure, which contains a highly neurotoxic tri-fluoridated methyl group attached to an amphetamine-like benzene keep sounding (= phenyl group). That particular moiety resulted in the banning (in 1997) of the methamphetamine-like, psycho-stimulating, desire-suppressing, weight-loss drug fenfluramine (of Fen-Phen odiousness) after it was discovered to be the subject of caused a number of cardiac deaths and solemn disability, including heart valve damage, original pulmonary hypertension, and the near full destruction of serotonin nerves in the fillet lobes of experimental monkeys who had been given but 4 doses of fenfluramine 17 months preceding to their being sacrificed and their mind examined.
The dramatic brain biopsies that proved this in earnest outcome were published in 1975, twenty years in the sight of the drug was widely prescribed to confiding over-weight patients by equally credulous weight-loss physicians!
Here is the molecular structure of flibanserin:
It is of influence to note that the portion of the ultimate particle at the end opposite of the tri-fluoridated phenyl collection has a structure that resembles each indole ring, which is the base erection of the serotonin molecule. The remedy company marketing this drug states that in the flibanserin rat studies, serotonin was raise to be “decreased” in the brains of the treated rats while dopamine and norepinephrine were lay the ~ation of to be “elevated”. Those tools and materials are consistent with what could have ~ing predicted to occur just from looking at the monad. The serotonin, dopamine and norepinephrine receptor sites and re-uptake pumps, merited like all antidepressants, anti-psychotics and psycho-stimulants, WILL have existence “messed with”, even poisoned, on the contrary not in brain-healthy ways.
Flibanserin has not nevertheless been tested – even in the sentient being labs – for long-term security or efficacy. That will be carried on in the Phase IV (post-marketing) studies, what one. are typically done in a chance fashion. Judging from the Phase III clinical trials, the medicine appears, at best, to be but marginally effective at raising female libido ~ the sake of only some patients. The study that was submitted to the FDA claimed that the patients infectious the drug experienced only approximately human being additional favorable sexual experience per month, compared to the placebo arrange.
Pharmaceutical companies typically exaggerate, by a sneaky statistical hoax, a drug’s effectiveness – the RRR (relating to risk reduction). One can therefore wait for flibanserin’s marketers (aiming at the two to physicians and the public) to claim a 30% or 40% relative risk improvement rate (which will have existence the deceptive “relative risk” amending figure and not the “true risk” improvement figure of one naturally liable to befall per month). Such statistical manipulations regularly witling both doctors and prospective patients to look forward to dramatic results – until reality hits a great quantity later.
Significant numbers of patients may have existence harmed and many will be disappointed with the mediocrity of the promised results, end in the meantime, some Big Pharma corporation will be raking in $400 for patient per month and some freedom from disease insurance companies will be reluctantly paying out $400 per month until the duped patients sicken or drop out because of the drug’s ineffectiveness and angrily repay the drug. Same old very useful strategy that drug companies have used conducive to generations, even with dangerous or inefficacious. drugs.
One of the published rat lab studies that I found online “suggested” that the sexually crude female rats used in the suffering, after being on flibanserin for weeks, “appeared” to observers to exist sexually interested in male rats, only that “suggested response” only happened ~wards the rats had been given injections of synthetic estrogen and progesterone drugs! Reading the study made me convulse my head, because the authors of the study (paid through the company) had not seen the perceptible clinical in-applicability of those tools and materials, which they regarded as good plenty reasons to proceed to human studies.
It is significant to realize that years earlier, this mix with ~s was thought by its original developer to be marketable as an antidepressant drug (it failed), probably because its molecular structure had more similarity to fluoxetine (Eli Lilly’s Prozac), fluvoxamine (Solvay Pharmaceutical’s Luvox) and fenfluramine (Wyeth’s Pondimin and Redux). Wyeth, incidentally, was acquired ~ dint of. Pfizer in 2009 for $68 billion subsequent Wyeth settled the fenfluramine liability claims despite an estimated $14 billion. Fenfluramine, it of necessity to be noted, is a after this banned, long-acting psychostimulant (but actual neurotoxic) drug because of the three very much electronegative fluorine atoms attached to its phenyl collection.
When its use as an antidepressant put ~s into failed, the original drug company gave up on it and sold its rights to Sprout.
What to transact Before Taking Flibanserin
My advice to coming patients, before submitting to an requiring great outlay, essentially untested and potentially dangerous brain-altering medicine, is to first find out on the supposition that your diminished libido was caused ~ means of current or previous psychiatric drug habit, since such usage (virtually epidemic in the US, especially as being women) is a major root consideration of sexual dysfunction in both men and women. That intelligence is vitally important, because flibanserin WILL NOT WORK in (and the deaden with narcotics is not intended for) patients whose intellectual faculties have been altered by prior or current psych drug usage.
Flibanserin is not indicated on this account that use in cases of drug-induced diminished libido. Sprout Pharmaceuticals in fact says, in its product information brochure, that the use of flibanserin is contraindicated in patients that are seizing any of the following (CYP3A4 hepatic enzyme inhibitor) medications, that include many SSRI antidepressants. Note this biassed list of commonly prescribed drugs that are CYPDA4 hepatic enzyme inhibitors):
Aminodarone, Azithromzcin, Cannabinoids, Cimetidine, Clarithromycin, Clotrimazole, Cyclosporine, Dexamethasone, Diltiazem, Disulfiram, Erythromycin, Ethinyl estradiol, Fluconazole, Fluoxetine (Prozac), Fluvoxamine (Luvox), Grapefruit juice, Isoniazid, Ketoconazole, Metronidazole, Miconazole, Nefazodone (Serzone), Paroxetine (Paxil), Propoxyphene (Darvon), Quinidine, Quinine, Ranitidine, Sertraline (Zoloft), Troglitazone, Valproic sour.
At the end of this indenture is another list of prescription drugs that be able to lower a person’s libido. Flibanserin is not intended to be used in the treatment of of that kind drug-induced sexual dysfunction.
SSRI-induced Sexual Dysfunction be possible to be Permanent
The amphetamine molecule-based, halogenated/fluoridated SSRI drugs like Prozac, Zoloft, Paxil and Luvox, are obvious for causing high rates of sexual dysfunction in the one and the other females and males, and SSRI-induced sexual dysfunction be possible to become permanent! See http://www.australianprescriber.com/repository/36/2/42/5 for a immaculate introduction to the problem. (Also watch this YouTube video taped ~ the agency of one of the victims of Post-SSRI Sexual Dysfunction (PSSD): https://www.youtube.com/watch?v=I3db98NVDMw.) There is a 3,700 part support group serving victims of PSSD. Info relating to that group is available at https://groups.yahoo.com/neo/groups/SSRIsex/info.
Sexual dysfunction symptoms have power to be caused by many psychiatric drugs. Symptoms contain diminished libido, anorgasmia, erectile dysfunction, delayed exclamation and inability to ejaculate – not to mention worsening stagnation, suicidality, homicidality, akathisia, memory loss, wakefulness, anhedonia and an “I don’t give a damn attitude” (all of which are libido killers).
Except for little by little and carefully stopping the offending mix with ~s, there is no effective treatment as being the most severe forms of SSRI-induced sexual dysfunction. Logic tells us that put ~s into-induced sexual dysfunction can’t have ~ing expected to resolve by adding not the same serotonergic or dopaminergic drug, all of whom final ~ brain problems that aren’t understood. And, virtuous like the withdrawal symptoms that always arise after discontinuing addictive medications, so drugs must be cautiously discontinued. In the declension-form of patients who have already adorn permanently sexually disabled because of SSRIs, just stopping the drug may not spiritual charge the problem.
Knowing what I carry into effect about the molecular structure of like psychoactive drugs as flibanserin, I would augur that an unknowable percentage of patients afflictive this medication on a long bound basis will be made worse in ~ one number of ways.
Please study the think fit of offending drugs immediately below and give notice to your healthcare provider, who may not have ~ing fully aware of these issues. The desire below is excerpted from the website of the International Society on account of Sexual Medicine.
Flibanserin has not been approved on the side of use in drug-induced sexual dysfunction. (http://www.issm.info/tuition-for-all/sexual-health-qa/the kind of-medications-might-lower-a-persons-libido/ )
Estrogen-containing drugs (may disgrace libido in men)
Finasteride (Proscar is prescribed as far as concerns treating prostate enlargement. Propecia is prescribed in spite of male-pattern baldness.)
Opioids (like morphine and oxycodone)
“This is not ~y exhaustive list.
“Patients who mean their medications are affecting their libido should report to their doctor. Some drugs cannot exist stopped abruptly and need a weaning full stop.
“Note: Testosterone contributes to sex urge in both men and women, further some drugs lower libido without impressive testosterone levels. Scientists are not exactly unerring how this happens, but it in a fair way involves specific brain centers that manipulate dopamine.”
Dr Kohls is a secret physician who practiced holistic, non-mix with ~s, mental health care for the the ~ time decade of his family practice course of action. He now writes a weekly file for the Reader Weekly, an choice newsweekly published in Duluth, Minnesota, USA. Many of Dr Kohls’ columns are archived at http://duluthreader.com/articles/categories/200_Duty_to_Warn.
90,000 PMU mares trapped in stalls in China?
Ambien negative furniture that’s of note is the exemplar that it might produce blocks of amnesia.