Flibanserin and Female hypoactive sexual desire disorder

Female hypoactive sexual desire disorder (HSDD)

Female hypoactive sexual desire disorder (HSDD) is one type of sexual problem that can affect women. It is characterized by low or absent sexual desire that cannot be attributed to another cause and results in difficulty in interpersonal relationships. HSDD is not well understood, and women may not report symptoms of difficulties to their health care providers. In August 2015, the U.S. Food and Drug Administration approved flibanserin, a non hormonal oral medication for the treatment of HSDD in pre menopausal women. Flibanserin is the only currently available pharmacologic treatment for HSDD. This article will provide an overview of flibanserin, including potential adverse reactions, special considerations for use, and implications for nursing practice.

Sexual health is a multifaceted state of physical, emotional, mental, and social well-being in relation to sexuality, and it includes not only the absence of dysfunction but also having pleasurable sexual experiences

disorders, including disorders of low desire, have complex etiologies that have been difficult to accurately define and treat. Researchers have estimated that approximately 12% of women will experience some type of self reported sexual problem in their lifetime, including problems with sexual desire. Hypoactive sexual desire disorder (HSDD) is one type of sexual problem reported by women, although the exact incidence is difficult to estimate because of lack of validated measurement tools, lack of clinical experts, and reluctance of women to discuss sexual concerns with their health care providers. Female HSDD is characterized by low or absent interest in sex that results in personal distress and difficulty within intimate relationships. Until recently there have been no approved pharmacologic therapies to treat HSDD in women. In August 2015, the U.S. Food and Drug Administration (FDA) approved flibanserin as the first medication to treat HSDD in premenopausal women (FDA).

Controversy Surrounding FDA Approval

The approval of the first pharmacologic treatment for HSDD in women has not been with out controversy. First, the prevalence of HSDD has been questioned. The prevalence of any female sexual problem has been reported at more than 40% by some researchers, although this figure is from a study that was published more than 16 years ago; the researchers did not specifically examine HSDD but instead included it among many other sexual complaints. In addition to questions about the prevalence of HSDD, some health care providers have questioned whether this disorder has been created merely to sell a product and increase pharmaceutical profits. Because there is no established norm for sexual desire, others have questioned whether HSDD is a condition that needs treatment or is a normal variant on a continuum of sexual expression and interest. These views conflict with those of clinicians and researchers who believe that women’s sexual health has been long overlooked and recognize HSDD as a prevalent condition that has not received enough attention.

An additional concern that has been raised is the possibility of off-label use in populations of women with a broader range of health conditions than were initially included in clinical trials. Women who participated in the clinical trials were excluded if they were taking multiple different medications or had preexisting medical conditions. Therefore, to meet the criteria for HSDD and treatment with flibanserin, a woman must be experiencing symptoms of HSDD that are not caused by a preexisting medical or psychiatric condition, medication/substance use, or difficulty within her relationship. Because no postmenopausal women were included in clinical trials, the FDA has approved flibanserin for use in only pre menopausal women, thus excluding a large population of women who may be experiencing low sexual desire. When all of these criteria are considered, the population of women who are considered appropriate candidates according to the FDA approval decision becomes narrower. This increases the chance that health care providers might choose to prescribe this medication for a broader population of women than was initially intended, which may increase the risk of adverse reactions.

Overview of Flibanserin

The exact mechanism of flibanserin in the treatment of HSDD among premenopausal women is not completely known. Flibanserin acts on serotonin and dopamine neurotransmitter systems that are involved in the sexual response system of the brain. Flibanserin initially underwent trials as an antidepressant but failed to receive FDA approval because of lack of efficacy. However, during the antidepressant drug trials it was noted that flibanserin had pro sexual effects. This backward translation of side effects led to a new FDA application with the indication of flibanserin for low sexual desire.

  • Dosage and Administration of Flibanserin

Flibanserin is supplied as a pink oval tablet for oral use. The recommended dose of flibanserin is 100 mg at bedtime. It is recommended for bedtime use only because of risks of hypotension, syncope, somnolence, and sedation. Taking the medication during waking hours could increase the risk of injury if central nervous system symptoms were to occur during typical activities during awake time hours such as driving, work, exercise, or other activities for which concentration and alertness are necessary. Missed doses should not be doubled or taken when the woman remembers. Instead, the next dose should be taken on the next day at bedtime.

  • Adverse Reactions about Flibanserin

There are possible adverse reactions that are important to consider. The FDA has required flibanserin to carry a black box warning to highlight the most significant of these potential reactions. Hypotension, possibly resulting in syncope, has occurred. Specifically, if flibanserin is taken with alcohol, the risk of severe hypotension and syncope increases; therefore; women who are taking flibanserin must not drink any alcohol for the duration of treatment. Additional central nervous system effects may include dizziness, fatigue, and sedation. During clinical trials, female mice developed malignant mammary tumors when exposed to dosages up to 10 times the recommended dosage; however, the clinical significance of this in humans is unknown.

  • Drug Interactions of Flibanserin

Flibanserin interacts with medications that are classified as weak moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors. Both classes of medication affect the metabolism of flibanserin and increase bio availability, resulting in greater flibanserin levels and potentially an increase in adverse reactions, specifically hypotension and syncope. Examples of strong CYP2C19 inhibitors include protein pump inhibitors, selective serotonin re uptake inhibitors, benzo diazepines, and anti fungals. CYP3A4 inhibitors include oral contraceptives, cimetidine, ranitidine, fluconazole, grapefruit juice, and antibiotics such as ciprofloxacin and erythromycin.

  • Contraindications about Flibanserin

In addition to the contraindications of alcohol and medications that may increase flibanserin levels, flibanserin should not be used by women with any hepatic impairment, even mild. Elevated flibanserin levels have occurred in women with hepatic impairment, and this has the potential to increase the risk of adverse events such as hypotension and syncope.

  • Special Populations about Flibanserin

Flibanserin is approved for use in pre menopausal women. There are no human data on safety in pregnancy. In animal studies fetal toxicity occurred during episodes of maternal toxicity from higher than recommended dosages. Animal models may not accurately reflect human safety or harm. Flibanserin is not recommended for pediatric or geriatric use and is not indicated for use during and after the menopause transition. Flibanserin is excreted in animal milk, but data are lacking on human milk. Because of the possibility of drug excretion in human milk and potential sedative effects on the infant, flibanserin is not recommended during lactation.

  • Implications for Nurses about Flibanserin

Diagnosing HSDD is challenging, and nurses must recognize that women may have experienced symptoms of this disorder for years before seeking treatment. Women with HSDD may report a variety of symptoms, including absent or low interest in or desire for sex and or inability to respond to sexual stimuli despite describing a healthy relationship with their partner. Women may feel frustrated and embarrassed and not sure of how to discuss their concerns with their health care provider. It is important to establish a nonjudgmental and supportive environment to facilitate taking a complete sexual history and full symptom disclosure.
Because of the potential risk for serious adverse reactions that could result in injury, flibanserin can be prescribed only by health care providers who have participated in pharmaceutical company–sponsored training, have completed a knowledge assessment, and have enrolled in the Risk Evaluation and Management Strategy program. The Risk Evaluation and Management Strategy program was a condition necessary for FDA approval of flibanserin. Additionally, pharmacies must also complete a similar program, train all pharmacy staff, and counsel women about the risk of alcohol use with each prescription that is dispensed. Nurses can help women locate a participating pharmacy and should be aware that it may not be the same pharmacy where a woman’s other prescriptions are filled. Education about the risks of using alcohol while taking flibanserin is extremely important. No safe level of alcohol has been established during treatment with flibanserin. It is important to assess baseline alcohol use and whether abstaining from alcohol for the duration of treatment is possible.

Result

Although the FDA approval of flibanserin represents a new treatment option for premenopausal women who are experiencing low sexual desire, the availability of this recent pharmacologic treatment is not without controversy. Women who are considering treatment with flibanserin will need to weigh a risk/benefit profile that includes the potential for serious adverse events and relatively small treatment efficacy. Nurses will be an integral part of the health care team for women taking flibanserin in the provision of education, support, reassurance, and assistance with obtaining prescriptions.

Read More:

Increasing women’s sexual desire

Reference:
Flibanserin and Female Sexual Desire by Heidi Collins Fantasia.

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