The Science Behind the Female Libido Pill

Kirtly Parker Jones to tell us

What women are saying

Hypersensitivity Reactions: Reactions including anaphylaxis, vardenafil 10 mg tablet reactions consistent with angioedema, pruritus, and urticaria have been reported with ADDYI. Immediately discontinue ADDYI and initiate appropriate treatment if hypersensitivity reaction occurs. Oral Contraceptives and Other Weak CYP3A4 Inhibitors: Increases flibanserin exposures and incidence of adverse reactions. Strong CYP2C19 Inhibitors: Increases flibanserin exposure which may increase risk of hypotension, syncope, and CNS depression. CYP3A4 Inducers: Use of ADDYI not recommended, flibanserin concentrations substantially reduced Digoxin: Increases digoxin concentrations, which may lead to digoxin toxicity.

What should I do if I accidentally use too much Addyi?

Most common adverse reactions (ADDYI incidence ≥2% and higher than placebo) are dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth. See Full Prescribing Information and Medication Guide, including Boxed Warning regarding hypotension and syncope in certain settings. Acquired HSDD refers to HSDD that develops in a patient who previously had no problem with sexual desire. ADDYI is not indicated for use in men. Hypoactive Sexual Desire Disorder (HSDD), commonly called “decreased libido”, affects approximately 10% of the female population across all age groups, according to the International Society for Sexual Medicine.

Other Interactions

With several national news organizations introducing the “little pink pill”, I thought it would be a good time to review HSDD. Signs and symptoms that might suggest a low sex drive include: Few, if any, thoughts or fantasies about sex Bothered by the lack of sex drive There are several things that can contribute to a decreased libido, including: Medical illnessHigh blood pressureCancerDiabetesCoronary artery diseaseNeurological disorders Medications such as birth control pills or antidepressants Lifestyle habitsToo much alcohol consumptionSmoking (which can decrease blood flow and decrease arousal)Street drugs Smoking (which can decrease blood flow and decrease arousal) Psychological issuesDepressionAnxietyStressPoor body imageHistory of sexual abuseHistory of negative sexual experience Relationship issuesLack of closenessUnresolved conflictsLack of communication as to your needsInfidelity Lack of communication as to your needs There are currently no FDA approved medications for the treatment of HSDD. However, on June 4, 2015, an advisory committee to the Food and Drug Administration (FDA) recommended approval, with conditions, of the drug Flibanserin. This medication is for the treatment of premenopausal women with HSDD. It would be the first medication approved to treat HSDD. more about that next on The Scope.

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This is the "Seven Domains of Women's Health" with Dr.

Why do you think sexual desire in women is not treated seriously by the medical community?

The advocacy group called “Even the Score” had a large presence at the FDA approval committee meeting. Their campaign supports gender equality when it pertains to drugs to treat sexual dysfunction. Many are concerned that the FDA has a gender bias when it comes to approving drugs for women. Currently the FDA has approved 26 medications that treat male sexual dysfunction and none that treat women’s. It acts on the dopamine and serotonin receptors in the brain. Kirtly Jones, on The Scope.

• Pink pills are part of a broader trend towards female-centered wellness.
• They can potentially enhance intimacy, confidence, and overall satisfaction.
• Unregulated products pose risks of contamination or inappropriate ingredients.
• Always verify product credentials and manufacturer reputation before purchase.

Interviewer: Dr. Jones, we've been reading much, as I would imagine our

The Big Pink Fight for the Little Pink Pill

Thus, only women with a dopamine and serotonin imbalance are candidates for this drug. This is not for everyone and only upon completion of a thorough examination should a woman with the diagnosis of Hypoactive Sexual Desire Disorder be prescribed this medication. (That is, assuming the FDA actually approves it.) If approved, “the little pink pill” will be as popular a term as the “little blue pill” has been for men. Interviewer: The little pink pill that helps women's sex drive. We're going to ask Dr. listeners have and seen the

• Pink pills are sometimes used to address sexual dysfunction in women.
• They are marketed as natural or holistic remedies, depending on ingredients.
• Medical approval varies; some are unregulated, over-the-counter supplements.
• Users should check for FDA approval or medical supervision before use.

news coverage on the little pink

How FDA decisions shape access

Brain activation patterns in women with acquired hypoactive sexual desire disorder and women with normal sexual function: a cross-sectional pilot study. Neural basis of hypoactive sexual desire disorder in women: an event-related fmri study. Holstege G. How the emotional motor system controls the pelvic organs. Attitudinal survey of women living with low sexual desire.

Incidence not known

Continued efficacy and safety of flibanserin in premenopausal women with hypoactive sexual desire disorder (HSDD): Results from a randomized withdrawal trial. Jayne C, Simon JA, Taylor LV, Kimura T, Lesko LM; SUNFLOWER study investigators. Open-label extension study of flibanserin in women with hypoactive sexual desire disorder. Effect of flibanserin treatment on body weight in premenopausal and postmenopausal women with hypoactive sexual desire disorder: A post hoc analysis. WARNING: HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS See full prescribing information for complete boxed warning.

Is Lack of Desire all in Our Heads??

Use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope. Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more standard alcoholic drinks that evening. Severe hypotension and syncope can occur when ADDYI is used with moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment; therefore, ADDYI use in these settings is contraindicated. INDICATION ADDYI (flibanserin) is indicated for the treatment of women less than 65 years of age with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to: A co-existing medical or psychiatric condition, The effects of a medication or other drug substance. Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. pill, it's being called "the

• The popularity of pink pills reflects increasing openness about female sexuality.
• They may also contain vitamins and minerals for overall reproductive health.
• Effectiveness depends on individual health conditions and underlying issues.
• Some formulations are designed for specific age groups or hormonal states.

female Viagra" which is probably not

Warnings & Precautions

70% of women want you to start the convo about sexual health.2 70% of women want you to start the convo about sexual health.2 The exact mechanism of action of Addyi is unknown. I testified at the FDA 10 years ago when Addyi was approved — a watershed moment that validated women’s sexual health with the first FDA approved option to treat women with frustrating low libido. In my practice, it opened conversations that had long been silenced and gave patients hope. “Addyi has helped me get my libido back. My sweet husband has been so patient with me for years now – I dreaded his advances – I can’t tell you how wonderful it has been to want sex again.” “When I heard about Addyi, I was curious if it would work for me.

IN CLINICAL TRIALS1, WOMEN ON ADDYI EXPERIENCED:

After only a few weeks on Addyi I’m already thinking about and wanting sex again!” “I used to dread going to bed with my husband, because I was never in the mood… he thought it was his fault. IQVIA Monthly Total Prescriptions Volume Data in the US. MEDICAL INFO: 844-746-5745 x 3 medicalaffairs@sproutpharma.com MEDICAL INFO: 844-746-5745 x 3 medicalaffairs@sproutpharma.com IQVIA Monthly Total Prescriptions Volume Data Comparing Addyi vs Vyleesi in the US. Ryan KL, Arbuckle-Bernstein V, Smith G, Phillips J. Let’s Talk About Sex: A Survey of Patients’ Preferences When Addressing Sexual Health Concerns in a Family Medicine Residency Program Office.

How should I store Addyi?

Multifunctional pharmacology of flibanserin: possible mechanism of therapeutic action in hypoactive sexual desire disorder. Sexual desire and the Female Sexual Function Index (FSFI): a sexual desire cutpoint for clinical interpretation of the FSFI in women with and without hypoactive sexual desire disorder. The Female Sexual Function Index (FSFI): A multidimensional self-report instrument for the assessment of female sexual function. Safety of flibanserin in women treated with antidepressants: A randomized, placebo-controlled study. Women with hypoactive sexual desire disorder compared to normal females: a functional magnetic resonance imaging study. accurate and we'll talk about

What does this approval mean for other women’s health products?

Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation, or partner. ADDYI is not indicated to enhance sexual performance. Moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors Known hypersensitivity to ADDYI or any of its components. Reactions, including anaphylaxis, reactions consistent with angioedema, pruritus, and urticaria have been reported. Hypotension and Syncope Due to an Interaction with Alcohol: See Boxed Warning for risks associated with alcohol consumption.

How can I get more information about Addyi?

After taking ADDYI at bedtime, advise patients to not use alcohol until the following day. Hypotension and Syncope with CYP3A4 Inhibitors: See Boxed Warning and Contraindication about use with moderate or strong cytochrome P450 3A4. Concomitant use of multiple weak CYP3A4 inhibitors that may include herbal supplements (e.g., ginkgo, resveratrol) or non-prescription drugs (e.g., cimetidine) could also lead to clinically relevant increases in flibanserin concentrations that may increase the risk of hypotension and syncope. Central Nervous System (CNS) Depression (e.g., Somnolence, Sedation): Can occur with ADDYI alone and is exacerbated by other CNS depressants. The risk of CNS depression is also increased if ADDYI is taken during waking hours.

Related support groups

Patients should avoid activities requiring full alertness (e.g., operating machinery or driving) until at least six hours after each dose and until they know how ADDYI affects them. Hypotension and Syncope with ADDYI Alone: The use of ADDYI - without other concomitant medications known to cause hypotension or syncope - can cause hypotension and syncope. The risk is increased if ADDYI is taken during waking hours or if higher than the recommend dose is taken. Syncope and Hypotension in Patients with Hepatic Impairment: Any degree of hepatic impairment significantly increases flibanserin concentrations, which can lead to hypotension and syncope. ADDYI is contraindicated in patients with hepatic impairment. that in a second as well.