FDA Approves New Libido Drug for Women; Natural Support is Far Safer
Just days ago, the FDA approved a new drug to help women with low sexual desire. Women beware. This is a drug that comes with some serious adverse effects and a stiff warning on the label. Wouldn't it be better to get to the root of low sex drive?
This new drug, Addyi (flibanserin), treats a new disorder called FSIAD or female sexual interest/arousal disorder. A similar older diagnosis is called HSDD or hypoactive sexual desire disorder in premenopausal women. This designer drug was created specifically for these new diagnoses and fills a “drug gap”. The Addyi produced by Sprout Pharmaceuticals barely made it through FDA approval as it failed several times in the process. One of the criteria before the drug could be released on the market was that only certain pharmacies and pharmacists would be allowed to dispense the drug in order to guard against the safety risks associated with the drug.
Addyi comes with some hefty side effects and a boxed warning. The major boxed warning side effects are problems with low blood pressure and fainting. The adverse effects risks are dangerously worsened with alcohol. This is a serious concern as many women of this age group tend to experience low blood pressure not induced by drug side effects. Other side effects noted were dizziness, sleepiness, nausea, fatigue, insomnia, dry mouth, and depression.
Furthermore, in testing the drug on female mice, it was noted that the drug caused malignant breast tumors at drug doses levels 4 to 13 times higher than recommended the normal therapeutic dose. How and why tumor growth happened was not identified. Despite the risk of tumor development that occurred with very high drug intake, the FDA advisory committee still approved the drug and noted that the “Addyi is essentially non-genotoxic and no different than mice that receive the placebo.”
The drug Addyi was evaluated with three double-blind, placebo-controlled trials involving 2,400 premenopausal women with low libido. Success of the drug was based on the number of satisfying sexual events experienced per month compared to those who received the placebo. The rate of improved satisfying events caused by using the drug was 0.5 to 1 event. Yes, you read that right. The drug was approved for a possible one-time event per month with regular use. The drug is meant to be taken long-term for months-years for full performance.
How Addyi works has not been completely identified. It was originally intended to be an anti-depressant, but failed. A small number of patients reported that their sex drive improved as a side effect with ongoing use of the drug. This adverse effect prompted a new treatment focus with the drug manufacturers. So, the drug mechanism is not known, very high doses cause breast tumors in female mice, and it marginally increases libido. Libido is a result of very complicated changes in hormonal expression, vascular and neurological activity in the body. It is likely the new designer drug will cost a small fortune even though it has minimal effect at best. How about just taking two placebo sugar pills and eating some oysters? More importantly, work on the health of the body.
The topic of low libido in women is not to be dismissed at all. It is nonsensical, sad, and alarming though that a drug that has failed repeatedly throughout its development is approved for the market with boxed warning and uncertainty. The FDA has required the drug company to be subject to drug safety monitoring over the next several months after it has been out on the market. Women struggling with this concern should be alert to the dangers of the drug and truly question its efficacy. Putting someone on a drug that drops blood pressure, which is essentially reducing blood flow to the brain, with perhaps combining it with alcohol that will also impair brain function, certainly raises the risk for impaired judgment and function, date rape, and other like consequences. Drug warnings often state do not operate heavy machinery or drive due to sedating side effects. Is this the new normal for drug safety?
Low libido is often a reflection of underlying hormonal imbalances, exhaustion, nutritional deficits, medication side effects, medical disorders, or other factors. It reflects a problem. It is a symptom of something out of balance or affected by outside stressors. Birth control pills are just one of the medications that can disrupt libido because of changes to hormonal balance. Antidepressant medications are notorious for shutting down libido. In addition, there are many more concerns that are often glossed over or ignored by the often quick fix medical mentality.
Low DHEA levels may contribute to poor libido. DHEA has been shown to help enhance sex drive in middle age adults. This natural adrenal steroid hormone must balance out cortisol levels in the body. Cortisol and DHEA have a teeter-totter balancing act. Very often, in states of prolonged high stress of any type, the body diverts the production of DHEA into cortisol production, i.e. high cortisol and low DHEA. This is to deal with the chronic unhappy grizzly bear knocking on your door. How many things are child bearing women dealing with multiple grizzly bears on a day to day basis? DHEA levels also tend to decline after the age of 30.
Other research shows that healthy testosterone levels and other androgens (hormones that support reproductive activity) are essential for women to sustain healthy libido. The Journal of Sex Medicine earlier this year studied 560 healthy women ages 19-65 and looked at levels of DHEA, testosterone, and androstenodione (an androgen hormone) and found that sexual desire statistically correlated with these hormone levels. Get your lab levels measured with labs that measure the ratios or balance of DHEA and cortisol before embarking on supplementation or medical support. Symptoms of excess cortisol and DHEA can mimic low levels or may be related with improper ratios. Too much and too little of either are problems. Also consider testing testosterone and androstenodione levels.
Hypothyroidism and adrenal insufficiency also results in decreased libido. Too little thyroid hormone can certainly result in loss of interest and desire along with fatigue, sluggishness, depression, and poor estrogen detoxification and imbalanced progesterone. The adrenal insufficiency or severe adrenal fatigue leads to inadequate androgen steroid hormones to be produced. This causes the lack of interest, fatigue, poor mood and other symptoms.
Women who are pregnant or are new mom’s fit in the category too low sexual interest. A 2012 study evaluated 80 Tunisian women ages 25-37. At least 54 percent of the women during pregnancy had low interest. After pregnancy and delivery, 64 percent of the women had reduced desire with interests resuming within a number of months post pregnancy.
Premature ovarian failure or early loss of the menstrual cycle before age 40 can also lead to symptoms of diminished libido. Premature ovarian failure can be related with genetic conditions, autoimmune damage to the ovaries. Chemotherapy, radiation, and infections are additional causes. Symptoms look just like menopause, but occur in women under the age of forty. This requires appropriate investigation.
Blood sugar dysfunction or diabetes is another common cause of low desire. This is more research demonstrating this effect in men, but the high levels of oxidative inflammation, poor circulation, neurological stress or insulin and leptin hormonal imbalances are prevalent in both men and women. In a study with 500 diabetic women with average age of 48, scientists looked at several different sexual dysfunction concerns. The overwhelming majority over 80 percent of the participants had low libido. This concern proved far greater than any other sexual difficulty. With diabetes and prediabetes at epidemic levels, it is no wonder that women struggle with these symptoms.
Cancer patients post treatment may struggle with this issue. A study with premenopausal breast cancer survivors showed they had significant concerns with loss of sexual desire and other hormonal imbalance symptoms. Certainly, patients with other cancer types may experience this loss as well.
Patients with autoimmune neurological disorders may have low desire as result of the neurological inflammation. This is indeed the case with multiple sclerosis patients. Cardiac disorders including heart failure is often associated with reduce libido. Even though heart failure is rare in child-bearing women, heart failure is certainly on the rise at alarming rates with the epidemic use of statin drugs even in younger women.
Endocrine disrupting compounds in the environment certainly do not help with libido. Herbicides, fungicides, insecticides and Bisphenol-A may block or disrupt the androgen (testosterone, androstenodione, and DHEA) hormones that are vital to healthy sexual desire. Science has not attempted to understand the effect of Roundup or glyphosate on libido with the exception of one animal study 20 years ago that showed male rabbits lost their libido after Roundup/glyphosate exposure. That certainly says a lot!
A lesser known cause of low libido is related with the pituitary gland in the brain. The pituitary gland receives signals from the hypothalamus and is related with multiple different endocrine or gland functions in the body. When the pituitary is damaged, enlarged, or becomes inflamed, a common symptom may be low libido. There are other symptoms as well that may be present. These include headache, excessive thirst and excessive urination, vision changes, and irregular menses or loss of cycle. So the “not tonight dear, I have a headache” scenario that persists with some of these other symptoms means that you need to be properly evaluated through your medical provider. This is serious and must not be overlooked. It can be life threatening.
There are many other areas of health that may interfere with libido like depression, anxiety, and others. The loss of libido is a symptom. With any of these scenarios that was identified or others that you may be aware of, don’t just dismiss the symptoms and think that the loss of libido is simply stress. Stress can certainly dampen the desire, but look at the whole picture. The goal is to evaluate why this is occurring and what can be done about. Big Pharma will certainly hype up this new designer drug to fit the new diagnoses. Medical providers may be eager to help patients with this new wonder drug but often don’t have a lot of time or interest for delving deeper. Simple common sense tells us that this new “purple pill” for women may open up a can of worms and is not much better than a sugar pill. Don’t allow your doc to dismiss the symptoms without first being a detective. The treatment to put you on the newest drug on the market, one with serious side effects and questionable effect, reflects terrible band-aid care.
This article identified many areas of health stress that contribute to low libido in a woman’s child-bearing years. Many of these same factors may affect men and older women too. Given our current health care system, it is safe to say that most medical providers and pharmacists certainly won’t address many of the concerns here as they relate to nutrition. Tens of millions in our country struggle with adrenal distress, hypothyroidism, blood sugar problems, or depression, which all affect libido. Get DHEA levels measured and support when needed. Simply nourishing the adrenal glands and reducing stress, inflammation and burn-out can go a long way to help the adrenal glands resume androgen steroid production and helping this concern.
Support your body's detoxification systems.There is daily exposure to endocrine disrupting compounds that interfere with the sex steroid hormone production and function in the brain and body, subtlety interfering with desire. If you think that you have reduced your body’s burden of estrogen disrupting compounds, look again. Take a mental inventory and see how you are doing with some of these things. These toxins are everywhere now more than ever, and the body must detoxify on an ongoing daily basis. It is highly unlikely that your medical provider will take this nutritional dependent detoxification process into consideration with the libido topic. Ask your natural nutrition-oriented provider for help if there are significant problems.
Birth control pills, anti-depressants, and many other medications end up robbing the body of the very nutrients needed for adrenal, thyroid, and androgen hormone balance.
Zinc is a mineral required by the adrenals and thyroid and is essential for sexual health and libido. Zinc must be properly balanced with copper; otherwise copper levels will decline as a result of supplemental zinc. Imbalanced copper and zinc levels are associated with low libido, as studied in men. It has not been studied in women, but certainly both nutrients being in balance are vital to many of the concerns with loss of libido and fertility health.
If there is insufficient iron or low serum ferritin and iron deficiency anemia, iron levels must be restored to correct libido. Many of these nutrients, especially zinc, iron, and folate, are deficient in gluten intolerance. Research shows that loss of libido and infertility problems are related with celiac disease or gluten intolerance. Once the gluten is removed and there is correction of these deficiencies, the libido and fertility returns. Certainly, the lack of minerals and absorption problems are heavily influenced with GMOs, Roundup/glyphosate, and gut microbiome changes.
A study in men showed the use and treatment of acetyl-l-carnitine, L-arginine, and ginseng helped improve poor libido and sexual performance. In women, l-arginine and ginseng taken with multi-vitamin and multi-mineral improved libido. The greatest benefit was seen in women who were pre- and perimenopause.
There are so many diverse causes of loss of sexual desire. This is often a taboo subject in women, but there are practical things like dietary changes, improving detoxification, reducing stress, and improving nutritional imbalances that provide tangible results. Men too can learn from this. This article does not address the fertility difficulties that women face, but much of this information is still applicable for that concern. Common sense tells me that a drug that causes severe low blood pressure problems and syncope/passing out to improve sexual pleasure and performance is down right dangerous on so many levels. Mother Nature has provided so many wonderful resources to keep and stay healthy!
This new drug, Addyi (flibanserin), treats a new disorder called FSIAD or female sexual interest/arousal disorder. A similar older diagnosis is called HSDD or hypoactive sexual desire disorder in premenopausal women. This designer drug was created specifically for these new diagnoses and fills a “drug gap”. The Addyi produced by Sprout Pharmaceuticals barely made it through FDA approval as it failed several times in the process. One of the criteria before the drug could be released on the market was that only certain pharmacies and pharmacists would be allowed to dispense the drug in order to guard against the safety risks associated with the drug.
Boxed Warning and Serious Side Effects
Addyi comes with some hefty side effects and a boxed warning. The major boxed warning side effects are problems with low blood pressure and fainting. The adverse effects risks are dangerously worsened with alcohol. This is a serious concern as many women of this age group tend to experience low blood pressure not induced by drug side effects. Other side effects noted were dizziness, sleepiness, nausea, fatigue, insomnia, dry mouth, and depression.
Furthermore, in testing the drug on female mice, it was noted that the drug caused malignant breast tumors at drug doses levels 4 to 13 times higher than recommended the normal therapeutic dose. How and why tumor growth happened was not identified. Despite the risk of tumor development that occurred with very high drug intake, the FDA advisory committee still approved the drug and noted that the “Addyi is essentially non-genotoxic and no different than mice that receive the placebo.”
Success?
The drug Addyi was evaluated with three double-blind, placebo-controlled trials involving 2,400 premenopausal women with low libido. Success of the drug was based on the number of satisfying sexual events experienced per month compared to those who received the placebo. The rate of improved satisfying events caused by using the drug was 0.5 to 1 event. Yes, you read that right. The drug was approved for a possible one-time event per month with regular use. The drug is meant to be taken long-term for months-years for full performance.
How Addyi works has not been completely identified. It was originally intended to be an anti-depressant, but failed. A small number of patients reported that their sex drive improved as a side effect with ongoing use of the drug. This adverse effect prompted a new treatment focus with the drug manufacturers. So, the drug mechanism is not known, very high doses cause breast tumors in female mice, and it marginally increases libido. Libido is a result of very complicated changes in hormonal expression, vascular and neurological activity in the body. It is likely the new designer drug will cost a small fortune even though it has minimal effect at best. How about just taking two placebo sugar pills and eating some oysters? More importantly, work on the health of the body.
The topic of low libido in women is not to be dismissed at all. It is nonsensical, sad, and alarming though that a drug that has failed repeatedly throughout its development is approved for the market with boxed warning and uncertainty. The FDA has required the drug company to be subject to drug safety monitoring over the next several months after it has been out on the market. Women struggling with this concern should be alert to the dangers of the drug and truly question its efficacy. Putting someone on a drug that drops blood pressure, which is essentially reducing blood flow to the brain, with perhaps combining it with alcohol that will also impair brain function, certainly raises the risk for impaired judgment and function, date rape, and other like consequences. Drug warnings often state do not operate heavy machinery or drive due to sedating side effects. Is this the new normal for drug safety?
Possible Low Libido Causes: Birth Control Pills and Antidepressant Medications
Low libido is often a reflection of underlying hormonal imbalances, exhaustion, nutritional deficits, medication side effects, medical disorders, or other factors. It reflects a problem. It is a symptom of something out of balance or affected by outside stressors. Birth control pills are just one of the medications that can disrupt libido because of changes to hormonal balance. Antidepressant medications are notorious for shutting down libido. In addition, there are many more concerns that are often glossed over or ignored by the often quick fix medical mentality.
Insufficient DHEA, Stressed Adrenals, and Hypothyroidism
Low DHEA levels may contribute to poor libido. DHEA has been shown to help enhance sex drive in middle age adults. This natural adrenal steroid hormone must balance out cortisol levels in the body. Cortisol and DHEA have a teeter-totter balancing act. Very often, in states of prolonged high stress of any type, the body diverts the production of DHEA into cortisol production, i.e. high cortisol and low DHEA. This is to deal with the chronic unhappy grizzly bear knocking on your door. How many things are child bearing women dealing with multiple grizzly bears on a day to day basis? DHEA levels also tend to decline after the age of 30.
Other research shows that healthy testosterone levels and other androgens (hormones that support reproductive activity) are essential for women to sustain healthy libido. The Journal of Sex Medicine earlier this year studied 560 healthy women ages 19-65 and looked at levels of DHEA, testosterone, and androstenodione (an androgen hormone) and found that sexual desire statistically correlated with these hormone levels. Get your lab levels measured with labs that measure the ratios or balance of DHEA and cortisol before embarking on supplementation or medical support. Symptoms of excess cortisol and DHEA can mimic low levels or may be related with improper ratios. Too much and too little of either are problems. Also consider testing testosterone and androstenodione levels.
Hypothyroidism and adrenal insufficiency also results in decreased libido. Too little thyroid hormone can certainly result in loss of interest and desire along with fatigue, sluggishness, depression, and poor estrogen detoxification and imbalanced progesterone. The adrenal insufficiency or severe adrenal fatigue leads to inadequate androgen steroid hormones to be produced. This causes the lack of interest, fatigue, poor mood and other symptoms.
Pregnancy, New Mom’s and Premature Ovarian Failure
Women who are pregnant or are new mom’s fit in the category too low sexual interest. A 2012 study evaluated 80 Tunisian women ages 25-37. At least 54 percent of the women during pregnancy had low interest. After pregnancy and delivery, 64 percent of the women had reduced desire with interests resuming within a number of months post pregnancy.
Premature ovarian failure or early loss of the menstrual cycle before age 40 can also lead to symptoms of diminished libido. Premature ovarian failure can be related with genetic conditions, autoimmune damage to the ovaries. Chemotherapy, radiation, and infections are additional causes. Symptoms look just like menopause, but occur in women under the age of forty. This requires appropriate investigation.
Blood Sugar and Diabetes
Blood sugar dysfunction or diabetes is another common cause of low desire. This is more research demonstrating this effect in men, but the high levels of oxidative inflammation, poor circulation, neurological stress or insulin and leptin hormonal imbalances are prevalent in both men and women. In a study with 500 diabetic women with average age of 48, scientists looked at several different sexual dysfunction concerns. The overwhelming majority over 80 percent of the participants had low libido. This concern proved far greater than any other sexual difficulty. With diabetes and prediabetes at epidemic levels, it is no wonder that women struggle with these symptoms.
Cancer, Autoimmune, and Cardiac Patients
Cancer patients post treatment may struggle with this issue. A study with premenopausal breast cancer survivors showed they had significant concerns with loss of sexual desire and other hormonal imbalance symptoms. Certainly, patients with other cancer types may experience this loss as well.
Patients with autoimmune neurological disorders may have low desire as result of the neurological inflammation. This is indeed the case with multiple sclerosis patients. Cardiac disorders including heart failure is often associated with reduce libido. Even though heart failure is rare in child-bearing women, heart failure is certainly on the rise at alarming rates with the epidemic use of statin drugs even in younger women.
Environmental Endocrine Disrupting Compounds
Endocrine disrupting compounds in the environment certainly do not help with libido. Herbicides, fungicides, insecticides and Bisphenol-A may block or disrupt the androgen (testosterone, androstenodione, and DHEA) hormones that are vital to healthy sexual desire. Science has not attempted to understand the effect of Roundup or glyphosate on libido with the exception of one animal study 20 years ago that showed male rabbits lost their libido after Roundup/glyphosate exposure. That certainly says a lot!
Pituitary Gland
A lesser known cause of low libido is related with the pituitary gland in the brain. The pituitary gland receives signals from the hypothalamus and is related with multiple different endocrine or gland functions in the body. When the pituitary is damaged, enlarged, or becomes inflamed, a common symptom may be low libido. There are other symptoms as well that may be present. These include headache, excessive thirst and excessive urination, vision changes, and irregular menses or loss of cycle. So the “not tonight dear, I have a headache” scenario that persists with some of these other symptoms means that you need to be properly evaluated through your medical provider. This is serious and must not be overlooked. It can be life threatening.
There are many other areas of health that may interfere with libido like depression, anxiety, and others. The loss of libido is a symptom. With any of these scenarios that was identified or others that you may be aware of, don’t just dismiss the symptoms and think that the loss of libido is simply stress. Stress can certainly dampen the desire, but look at the whole picture. The goal is to evaluate why this is occurring and what can be done about. Big Pharma will certainly hype up this new designer drug to fit the new diagnoses. Medical providers may be eager to help patients with this new wonder drug but often don’t have a lot of time or interest for delving deeper. Simple common sense tells us that this new “purple pill” for women may open up a can of worms and is not much better than a sugar pill. Don’t allow your doc to dismiss the symptoms without first being a detective. The treatment to put you on the newest drug on the market, one with serious side effects and questionable effect, reflects terrible band-aid care.
How to Improve Libido
This article identified many areas of health stress that contribute to low libido in a woman’s child-bearing years. Many of these same factors may affect men and older women too. Given our current health care system, it is safe to say that most medical providers and pharmacists certainly won’t address many of the concerns here as they relate to nutrition. Tens of millions in our country struggle with adrenal distress, hypothyroidism, blood sugar problems, or depression, which all affect libido. Get DHEA levels measured and support when needed. Simply nourishing the adrenal glands and reducing stress, inflammation and burn-out can go a long way to help the adrenal glands resume androgen steroid production and helping this concern.
Detoxify
Support your body's detoxification systems.There is daily exposure to endocrine disrupting compounds that interfere with the sex steroid hormone production and function in the brain and body, subtlety interfering with desire. If you think that you have reduced your body’s burden of estrogen disrupting compounds, look again. Take a mental inventory and see how you are doing with some of these things. These toxins are everywhere now more than ever, and the body must detoxify on an ongoing daily basis. It is highly unlikely that your medical provider will take this nutritional dependent detoxification process into consideration with the libido topic. Ask your natural nutrition-oriented provider for help if there are significant problems.
Imbalanced Nutrients and Underlying Gluten Intolerance
Birth control pills, anti-depressants, and many other medications end up robbing the body of the very nutrients needed for adrenal, thyroid, and androgen hormone balance.
Zinc is a mineral required by the adrenals and thyroid and is essential for sexual health and libido. Zinc must be properly balanced with copper; otherwise copper levels will decline as a result of supplemental zinc. Imbalanced copper and zinc levels are associated with low libido, as studied in men. It has not been studied in women, but certainly both nutrients being in balance are vital to many of the concerns with loss of libido and fertility health.
If there is insufficient iron or low serum ferritin and iron deficiency anemia, iron levels must be restored to correct libido. Many of these nutrients, especially zinc, iron, and folate, are deficient in gluten intolerance. Research shows that loss of libido and infertility problems are related with celiac disease or gluten intolerance. Once the gluten is removed and there is correction of these deficiencies, the libido and fertility returns. Certainly, the lack of minerals and absorption problems are heavily influenced with GMOs, Roundup/glyphosate, and gut microbiome changes.
Additional Nutrient Support
A study in men showed the use and treatment of acetyl-l-carnitine, L-arginine, and ginseng helped improve poor libido and sexual performance. In women, l-arginine and ginseng taken with multi-vitamin and multi-mineral improved libido. The greatest benefit was seen in women who were pre- and perimenopause.
There are so many diverse causes of loss of sexual desire. This is often a taboo subject in women, but there are practical things like dietary changes, improving detoxification, reducing stress, and improving nutritional imbalances that provide tangible results. Men too can learn from this. This article does not address the fertility difficulties that women face, but much of this information is still applicable for that concern. Common sense tells me that a drug that causes severe low blood pressure problems and syncope/passing out to improve sexual pleasure and performance is down right dangerous on so many levels. Mother Nature has provided so many wonderful resources to keep and stay healthy!
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