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8. Biddle AK, West SL, D’Aloisio AA, Wheeler SB, Borisov NN, Thorp J, et al. Hypoactive sexual desire disorder in postmenopausal women: Quality of life and health burden. Value Health. 2009; 12 :763–72. [PubMed] [Google Scholar]

Flibanserin: A controversial drug for female hypoactive sexual desire disorder

This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.

Abstract

Sexual functioning is an integral part of human life. Female sexual dysfunction (FSD) adversely affects quality of life and general well-being. The Food and Drug Administration recently approved flibanserin, for treatment of female hypoactive sexual desire disorder (HSDD), regarded as the most common FSD, amid great controversy. A novel multifunctional serotonin agonist and antagonist, flibanserin, has been shown to be efficacious in treating HSDD but with a rather tenacious side effect profile. We review this interesting drug in its entirety. Data for the article were collected by reviewing articles on PubMed, the drug (Addyi) website, and related websites on the internet.

Sexual functioning is an integral part of human life and has been shown in research to be important to both men and women[1] In the Study of Women’s Health across the Nation, more than 75% of women reported sex to be moderately to extremely important.[2]

Around 43% of women report sexual problems with 22.2% reporting sexually related personal distress.[3] Hypoactive sexual desire disorder (HSDD) has been regarded to be the most common female sexual dysfunction (FSD) and affects nearly 1 in 10 women.[4,5] It is a persistent or recurrent absence of deficiency of sexual desire or receptivity to sexual activity that causes marked distress or interpersonal difficulty.[6] For a diagnosis of HSDD, the desire problem must not be better accounted for by another psychiatric disorder such as depression, substance abuse, or medical condition.[7] Not only does FSD negatively affect health-related quality of life but also general well-being.[8,9]

HSDD was removed from the fifth edition of Diagnostic and Statistical Manual of Mental Disorder (DSM-V). Its symptoms were established as a criterion for female sexual interest/arousal disorder. However, ACOG recognizes HSDD as a separate entity.[6]

Originally developed as an antidepressant, with a potentially rapid onset of action, flibanserin was approved by the Food and Drug Administration (FDA) for HSDD in August 2015 despite the removal of HSDD from DSM-V.[10,11] The approval came with the caveat that the drug be dispensed through a special risk management program. It is the first FDA-approved drug for treatment of premenopausal women with acquired, generalized HSDD. We review this drug in its entirety, controversies surrounding its approval, dosage, pharmacokinetics, indications, adverse effects, and contraindications.

MECHANISM OF ACTION

Flibanserin is a novel multifunctional serotonin agonist and antagonist.[12]

Libido is positively regulated by synaptic dopamine and also other microcircuits where norepinephrine, testosterone, and estrogen act. Libido is negatively modulated by microcircuits where prolactin and serotonin act.[12,13,14] It implies relative deficiency of microcircuit dopamine and norepinephrine, or a relative excess of microcircuit serotonin can lead to disorder of sexual interest and desire.

Flibanserin has two principal pharmacological actions in neural microcircuits: it acts as a full agonist at postsynaptic 5HT1A receptors and an antagonist at postsynaptic 5HT2A receptors.[12,15] Exclusive binding at these receptors differentiates flibanserin from buspirone and bupropion.[4] This action in the prefrontal cortex causes the downstream release of dopamine and norepinephrine and reduction of serotonin, consistent with sites of abnormal neuroimaging described in patients with reduced sexual interest and desire.[12,16,17] Flibanserin acts selectively on pyramidal neurons that excite brainstem 5HT neurons yet also selectively on pyramidal neurons that inhibit brainstem Norepinephrine and Dopamine neurons.[15]

PHARMACOKINETICS

Flibanserin shows linear and dose proportional kinetics following a single oral dose (5–150 mg) and multiple oral doses (total daily dose ranging from 60 to 300 mg).[4] It is 90% absorbed and has mean half-life of ~ 11 h. With mild hepatic impairment, half-life increases to 26 h. Taking the drug with food increases its absorption. It has 98% protein binding, primarily to albumin. Its oral bioavailability is 33%.[18] Steady state of flibanserin is achieved only after 3 days of dosing and so it is incorrect to call it “female Viagra” because Viagra is used as needed.[19]

Flibanserin undergoes oxidative metabolism by CYP3A4 and to a lesser extent by CYP2D6 cytochrome P450 isoenzymes. Concomitant CYP3A4 inhibitors may increase flibanserin exposure and are contraindicated. Flibanserin may be used 2 weeks after the last dose of a moderate or strong CYP3A4 inhibitor. A moderate or strong CYP3A4 inhibitor may be initiated 2 days after the last dose of flibanserin. Strong CYP3A4 inhibitors include ketoconazole, itraconazole, clarithromycin, nefazodone, ritonavir, indinavir, and conivaptan. Moderate CYP3A4 inhibitors include atazanavir, ciprofloxacin, diltiazem, verapamil, erythromycin, fluconazole, and grapefruit juice. Weak CYP3A4 inhibitors such as oral contraceptive pills, cimetidine, fluoxetine, Ginkgo biloba, and ranitidine may be associated with increased risk for hypotension, syncope, and central nervous system (CNS) depression.[18,19]

Furthermore, CYP3A4 inducers can substantially reduce flibanserin concentrations and are not recommended with it. These include etravirine, carbamazepine, phenobarbital, phenytoin, rifampin, and St. John’s wort.[19]

The use of flibanserin in patients who are CYP2C19 poor metabolizers results in increased flibanserin concentrations and may increase the risk of hypotension and syncope. These patients should be closely monitored for adverse reactions. These include drugs such as proton-pump inhibitors, selective serotonin reuptake inhibitors, benzodiazepines, and antifungals.[19]

Flibanserin inhibits P-glycoprotein. Increased monitoring of concentrations of drugs transported by P-glycoprotein that have a narrow therapeutic index such as digoxin and sirolimus is indicated.

Flibanserin is excreted mostly through bile and the kidneys as inactive metabolites.[20]

DOSING

Administration during waking hours increases risk of hypotension, syncope, accidental injury, and depression. It is discontinued after 8 weeks if no improvement occurs.[18,19,20]

In case of missed dose, the patient should take the next dose at bedtime the next day. Doses should not be doubled.

Currently, it is not indicated in postmenopausal women or in men. Neither is it indicated to enhance sexual performance.[20]

CONTRAINDICATIONS

ADVERSE REACTIONS

Flibanserin may cause CNS depression with somnolence and sedation. Fatigue, insomnia, and dry mouth can also occur. Patients should not drive or engage in other activities requiring full alertness until at least 6 h after taking flibanserin. Concomitant use of CNS depressants such as diphenhydramine, opioids, hypnotics, and benzodiazepines may increase this risk.

Flibanserin by itself can cause hypotension and syncope.

Mice studies have shown dose-related increase in the incidence of malignant mammary tumors in female mice at exposures 3 and 10 times the recommended clinical dose. This was not seen in male mice or in male or female rats. However, clinical implications of these findings are unknown at present.[19]

PREGNANCY AND LACTATION

Adverse events were observed in some animal reproduction studies. It should be avoided in pregnancy. Flibanserin is excreted in rat milk. However, human data are not available and it is not recommended during breastfeeding at present.[19,20]

CONTROVERSIES PLAGUING FLIBANSERIN

Does HSDD at all exist? Considering that it was no more included as a separate entity in DSM-V, is drug treatment the right way forward?[21]

Is flibanserin safe enough to recommend its use? Safety and adverse effect date of flibanserin are still accumulating. According to meta-analysis by Jaspers et al., premenopausal and postmenopausal women taking flibanserin experienced 0.5 more satisfying sexual encounters a month and scored 0.3 points higher on a 5-point sexual desire scale. They concluded that these modest benefits did not outweigh harms.[20,21,22] According to FDA, flibanserin increased somnolence, sedation, or fatigue compared with placebo: 21% versus 8%![23]

Approval controversy: In 2009, Boehringer Ingelheim applied for approval of flibanserin to treat HSDD in premenopausal women. However, the FDA’s clinical reviewers and an external advisory committee voted unanimously against the drug 11-0. This was because the drug was noted to cause substantial somnolence and dangerous interactions with alcohol and other drugs and having failed to improve sexual desire measured with a daily electronic diary. Boehringer sold the rights of flibanserin to Sprout which resubmitted it for FDA approval in 2013 and was rejected yet again. The FDA concluded that only “numerically small treatment differences compared to placebo” were obtained with the drug which “do not clearly outweigh safety concerns.” In 2015, Sprout resubmitted flibanserin to the FDA and the drug was approved. However, the resubmission included no new benefit data! Within 48 h of the FDA approval, flibanserin was sold to Valeant Pharmaceuticals for about billion 1$ in cash[21]

A coalition of women’s groups, even the score, had actively campaigned for the drug’s approval, emphasizing that several approved drugs for male sexual dysfunction exist but not so for women. Quite ironically, the campaign was managed by blue engine message and media, a public relations firm, and received funding from Sprout.

CONCLUSION

Flibanserin is a controversial drug approved for a controversial disorder amid huge controversy. While it may serve as the lamp in the light in the long search for female sexual problems, it has still a long way to go. Women taking this drug must well be educated about the adverse events associated with this drug and the possible interactions. Until further data are available, a cautious use of the drug is warranted.

Financial support and sponsorship

Conflicts of interest

REFERENCES

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Articles from Industrial Psychiatry Journal are provided here courtesy of Wolters Kluwer — Medknow Publications

Man Sentenced to More than 8 Years in Prison for Illegally Importing, Selling Male Sexual Enhancement Pills Branded as ‘Herbal’ Medicine

LOS ANGELES – A Walnut man was sentenced today to 100 months in federal prison for illegally importing from China and selling $11 million worth of pharmaceutical-grade erectile dysfunction drugs that were falsely marketed as herbal remedies for men, some of whom suffered permanent injuries after consuming them.

John Seil Lee, 41, was sentenced by United States District Judge Percy Anderson, who ordered him remanded into federal custody. Judge Anderson – who also ordered Lee to pay more than $552,000 in restitution to his victims, including men who were injured by Lee’s misbranded pills – remarked in court on Lee’s “callousness” and how Lee’s “scheme has literally ruined lives.”

“It’s obvious to me,” Judge Anderson said, “that this defendant has little or no respect for the law or the harm he caused numerous victims.”

On February 27, Lee pleaded guilty to three felony counts of conspiracy, importing contraband into the United States, and filing a false tax return.

Lee’s companies – KHK International Trade Enterprise, Inc., and SHH World Trading Enterprises, Inc. – each were sentenced today to five years’ probation. KHK was fined $100,000 and SHH was ordered to pay its victims $115,484 in restitution. Lee’s companies each pleaded guilty in February to two felony counts of introducing misbranded drugs into interstate commerce.

From 2011 through early 2017, Lee illegally imported shipments of powder Tadalafil – a prescription drug used to treat erectile dysfunction and sold under the brand name Cialis – from suppliers in China. Lee then manufactured the powder Tadalafil into at least 5.5 million pills that he sold to distributors across the United States. In order to boost sales, Lee made the pills with up to 14 times the level of Tadalafil contained in Cialis.

Lee sold at least $11 million worth of pills across the United States – under names such as “X Again,” “X Monster” and “Royal Master” – with labels that did not disclose the presence of Tadalafil and falsely stated that no prescription was necessary, according to court documents. Lee also continued selling the pills despite FDA announcements that the pills were tainted because they contained undeclared Tadalafil. In order to evade federal regulators, Lee relabeled the tainted pills in response to FDA announcements about their safety, the information states. For example, in August 2016, after the FDA announced that SHH’s “One More Knight” pills contained undisclosed Tadalafil, Lee rebranded the same pills as “Own the Knight” and continued selling them.

After Lee closed SHH following the execution of federal search warrants in February 2017, he helped his friend Jin Su Park set up RNG Global Management and Trading Group to operate as a copycat business, according to Park’s plea agreement and statements made in court today. Park took 14,000 of Lee’s pills, rebranded them as “EEZZY UP PLATINUM,” and sold them to Lee’s former distributors across the country. EEZZY UP’s packaging also failed to disclose that the pills contained Tadalafil.

The FDA’s approval of Cialis is limited to the use under the supervision of a licensed professional. Due to toxicity and other potentially harmful effects – including life-threatening drops in blood pressure, loss of vision, loss of hearing and prolonged, painful erections that can result in permanent injury – drugs similar to Cialis are not safe for use except under the supervision of a medical practitioner.

In addition to the convictions of Lee, KHK, and SHH, federal prosecutors have obtained 13 guilty pleas from individuals and companies who conspired with Lee to distribute his misbranded erectile dysfunction drugs. These defendants are scheduled to be sentenced by Judge Anderson over the next several months.

The investigation into these cases was conducted by U.S. Immigration and Customs Enforcement’s Homeland Security Investigations, the Food and Drug Administration’s Office of Criminal Investigations and IRS Criminal Investigation.

The cases are being prosecuted by Assistant United States Attorney Matthew W. O’Brien of the Environmental and Community Safety Crimes Section.

Hidden active pharmaceutical ingredients have been identified in products promoted not only for sexual enhancement, but also for bodybuilding, pain relief and weight loss. The FDA has issued hundreds of public warnings and recall announcements related to these types of fraudulent products. The FDA’s Tainted Products database can help consumers identify some of these potentially harmful products. Even if a product is not included in the list, consumers should be cautious about using certain products, especially those promoted for sexual enhancement, weight loss, bodybuilding and pain relief.

How the Controversial ‘Female Viagra’ Made a Comeback

Three years ago, the first and only drug approved by the U.S. Food and Drug Administration for female sexual drive hit the shelves, and for a moment, it seemed that women finally had their own version of Viagra.

Called Addyi, the little pink pill promised to help women reinvigorate their sex lives. However, soon after the drug launched, its developer Sprout Pharmaceuticals was sold and excitement around the new pill came to a screeching halt.

Now, the drug is back with an enticing new price tag and a revived distribution model. Recently relaunched by Sprout Pharmaceuticals, Addyi is officially available for purchase via telemedicine, where doctors can diagnose and prescribe patients online.

While the original pill cost a whopping $800 per month, it will now go for $99 per month out of pocket. It may be just $25 if your insurance covers it.

Addyi, also known as flibanserin, is a daily, nonhormonal prescription pill for women in premenopause who suffer from hypoactive sexual desire disorder (HSDD). In other words, it’s for women who experience a chronically low libido that causes extreme interpersonal strain and distress.

Many women pass off HSDD as normal ebbs and flows in sexual desire. But symptoms typically last for a minimum of six months and can include anything from little to no interest in sexual activity to few to no sexual thoughts or fantasies and lack of pleasure when the genitals are stimulated.

Thus far, it’s been somewhat tricky for clinicians to understand what, specifically, causes HSDD. However, as Addyi’s package label notes, it’s not caused by preexisting medical or mental health problems, relationship issues, or other medicine or drug use.

Women have long awaited a female Viagra to ramp up their sex drives. However, Addyi functions quite differently from its male counterpart. While Viagra improves a man’s erection by boosting blood flow to the genitals, Addyi addresses a woman’s desire for sex, not the sex organs.

It does this by working on the part of the brain that’s in charge of sexual interest. It targets the neurotransmitters dopamine, norepinephrine, and serotonin.

Thus far, researchers haven’t been able to decode why or how serotonin affects libido. However, as a result of taking Addyi, women may experience stronger sexual desire and more “sexually satisfying events” each month (think intercourse, oral sex, masturbation, or genital stimulation by a partner).

Researchers did find that the increase in sexually satisfying events was small. They reported an increase of about one-half of a sexually satisfying event every month.

Some experts claim the overall results are minimal.

“The bigger issue, for me, is that the effect sizes are tiny for a drug you’re supposed to take every day for the rest of your life,” Nicole Prause, PhD, a sexual psychophysiologist and founder of the sexual biotechnology company Liberos, told Healthline. “Depending on the study, they’re finding less than one ‘extra’ satisfying sex episode per month.”

And then there are the black box warnings for the drug, which include dry mouth, insomnia, dizziness, drowsiness, nausea, and severely low blood pressure.

When mixed with alcohol, Addyi may even cause some women to pass out. In fact, those who order the drug must first sign a contract stating they won’t consume alcohol while taking Addyi.

Lastly — and perhaps most notably — is the root cause of a low libido. Women who suffer from HSDD tend to have hormonal imbalances, such estrogen, testosterone, and progesterone deficiency, none of which are altered by Addyi.

Additionally, research has shown that relationship and interpersonal issues have a profound impact on woman’s desire to have sex. Perhaps you just had a child, got in a fight with your partner, or simply aren’t feeling connected that day — all of these things can attribute to a fatigued desire to have sex. Because of this, many health experts claim a simple pill can’t solve these issues.

“Sex drive problems are most often due to a discrepancy with the partner, not a truly low drive, so couples therapy — like behavioral couples therapy — can be helpful. The challenge is, of course, everyone wants a shortcut,” Prause said.

Research indicates that up to 43 percent of women have a low sexual desire worldwide, however, only 10 percent suffer from HSDD, a prerequisite for Addyi.

“I think one thing to understand regarding Addyi is that it’s not as simple as taking one pill a day and all of the sudden changing into a different person,” said Dr. Michael Ingber, a urologist at the Center for Specialized Women’s Health in New Jersey. “For Addyi to be successful, women who take it will still need other factors, including the right mood, decreased stress levels, and of course, the appropriate partner.”

Many women who take the drug will experience some degree of increase in sexual drive compared to the baseline, Ingber noted.

Sexual function in women is complex. Women who have a low libido should have a sexual medicine evaluation to effectively understand and treat the various factors at play. In addition, consulting with a mental health expert along with a sex therapist can be crucial in building a healthy sex life.

So, while Addyi might not be a one-stop shop for most women, it may very well help provide some much-needed change in libido that some women are after.

How we reviewed this article:

Our experts continually monitor the health and wellness space, and we update our articles when new information becomes available.

Sildenafil

Sildenafil is used to treat erection problems. Find out how to take it safely and the possible side effects. Sildenafil is also called Viagra, Vedafil and Silvasta.

What is sildenafil?

Sildenafil is used for men with erection problems (erectile dysfunction). It works by increasing blood flow to the penis, to help achieve an erection. It will only work if you are sexually excited. Read more about erectile dysfunction.

Dose

In Aotearoa New Zealand sildenafil is available as tablets (25 mg, 50 mg and 100 mg).

  • The dose of sildenafil can be either 25 mg, 50 mg or 100 mg. The dose depends on your response and age.
  • Sildenafil is taken as a single dose before sexual activity. Do not take more than 1 dose a day.
  • Always take your sildenafil exactly as your doctor has told you. The pharmacy label on your medicine will tell you how much sildenafil to take, how often to take it and any special instructions.

How to take sildenafil

  • Timing: Take your dose 30 minutes to 1 hour before you intend to have sex. Sildenafil can keep working for up to 4 hours.
  • Swallow the tablet whole with a full glass of water. Do not take with grapefruit or orange juice.
  • You can take it with or without food. It may take longer to work if you take it with a heavy meal. Avoid excessive alcohol as it can lessen the sexual response.
  • Effectiveness: PDE5 inhibitors do not work for everyone – about 30% of men don’t see an improvement. Many men need to try the medication a few (6–8) times before it works. If you don’t have any improvement, do not increase your dose. Instead, talk to your doctor as there may be other treatment options.

How do I get sildenafil?

Sildenafil is available on prescription from your doctor. It is not funded in Aotearoa New Zealand for general erectile dysfunction. None of the PDE5 inhibitor medications are funded in New Zealand for general erectile dysfunction.

You can buy sildenafil directly from some pharmacies after a consultation with the pharmacist. Only pharmacists who have completed additional training can supply sildenafil. To make sure it is safe for you, they will measure your blood pressure and ask questions (such as what other medicines you are taking). You need to be aged 35–70 years to be eligible for this service. The pharmacy will also need to record your name and address. Here you can find Pharmacies that offer this service.

Precautions before taking sildenafil

  • Have you ever had a stroke?
  • Do you have any heart or blood pressure problems?
  • Do you have an eye problem called optic neuropathy?
  • Do you have leukaemia (cancer of the blood cells) or multiple myeloma (a cancer of the bone marrow)?
  • Do you have sickle cell disease?
  • Do you have any disease or deformity of your penis?
  • Do you have any bleeding disorders?
  • Do you have a stomach ulcer?
  • Do you have kidney or liver problems?
  • Are you taking any other medicines including alpha blocker medicine (such as doxazosin, terazosin, prazosin)?
  • Are you taking any over-the-counter and complementary medicines, eg, vitamins, minerals, herbal or naturopathic medicines?

If you have answered yes to any of these questions, it’s important that you tell your doctor or pharmacist before you take sildenafil. Sometimes a medicine isn’t suitable for a person with certain conditions, or it can only be used with extra care.

Sildenafil has several medication interactions so check with your doctor or pharmacist before starting sildenafil.

Nitrates and sildenafil should NOT be taken together, as both medicines together can cause a dangerous drop in blood pressure and collapse. Nitrates come in a variety of forms. Examples of nitrates are:

What are the side effects of sildenafil?

Like all medicines, sildenafil can cause side effects, but not everyone gets them. Often side effects improve as your body gets used to the new medicine.

  • Blocked nose
  • Sensation of redness and warmth or burning of the face (called facial flushing)
  • These will pass quite quickly.
  • Headache
  • Dizziness
  • Muscle aches and pains
  • Tell your doctor if they bother you.
  • If dizzy, do not drive or operate heavy machinery.
  • Indigestion
  • Tell your doctor if it bothers you.
  • An erection that lasts longer than 4 hours
  • Painful erection
  • Chest pain
  • Rash or swelling of the face
  • Sudden problems with your eyesight such as loss of vision, in one or both eyes
  • Sudden loss of hearing
  • Tell your doctor immediately or ring Healthline 0800 611 116.

Learn more

  • Sildenafil (for erectile dysfunction) NZ Formulary, NZ
  • Viagra Medsafe Consumer Information Sheet, NZ
  • Silvasta Medsafe Consumer Information Sheet, NZ
  • Vedafil Medsafe Consumer Information Sheet, NZ

References

Resources

Te reo resources

The Māori Pharmacists’ Association Ngā Kaitiaki o Te Puna Rongoā has a free phone line to answer questions whānau have about their medicines. Call 0800 664 688.

Note: This is a non-urgent service and they will get back to you within 24 hours.
For urgent health advice freephone Healthline 0800 611 116.

5 questions to ask about your medications

Health Quality and Safety Commission, NZ, 2019

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