Citizens Petition Calls for Sexual Side Effect Warnings

Researchers take action after study exposes enduring sexual dysfunction as a potential side effect of serotonin reuptake inhibiting antidepressants, 5α-reductase inhibitors, and isotretinoin.

Hannah Emerson
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A new study, published in the International Journal of Risk and Safety in Medicine, examines clinical reports of post-SSRI sexual dysfunction (post-antidepressant use), post-finasteride syndrome (PFS, following treatment for hair loss or enlarged prostate), and sexual dysfunction as a side effect upon terminating the treatment of isotretinoin (used to treat severe nodular acne, more commonly known as Accutane). The researchers, Healey, Le Noury, and Mangin, examined 300 cases of enduring sexual dysfunction from 37 countries.

“While reports of certain issues were unique to the antidepressants, such as the onset of premature ejaculation and persistent genital arousal disorder (PGAD), there was also a significant overlap in symptom profile between the drug groups, with common features including genital anaesthesia, pleasureless or weak orgasm, loss of libido and impotence,” the authors write. “Secondary consequences included relationship breakdown and impaired quality of life.”

Photo Credit: Flickr

Serotonin reuptake inhibiting medications can impact sexual functioning, and the current product datasheets report that this can occur after just the first dose. Finasteride and Isotretinoin have been indicated to have acute effects on sexual functioning. While Finasteride states this information on its label, Isotretinoin does not.

The first reports of enduring sexual side effects from serotonin reuptake inhibitors (SSRIs) were documented in 2006. In 2011, the US product information for Prozac (fluoxetine) warned, “Symptoms of sexual dysfunction occasionally persist after discontinuation of fluoxetine treatment.” Two years later, the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) published similar warnings, noting sexual dysfunction may persist after SSRI discontinuation “in some cases.”

In 1997, Finasteride was licensed to treat male baldness, but the first reports of enduring sexual dysfunction did not appear until 2011. That same year, the FDA updated the product information, warning of erectile dysfunction after stopping Proscar and Propecia. One year later, decreased libido was added to potential side effects after stopping Proscar, and libido disorders, ejaculation disorders, and orgasm disorders were added to the risks after discontinuation of Propecia. Finally, a 1994 report on ejaculatory disorder resulting from isotretinoin documented more than 150 reports of male sexual dysfunction.

In order to analyze post-treatment sexual dysfunction relating to serotonin reuptake inhibitors, 5α-reductase inhibitors and isotretinoin, Healy and colleagues utilized data from RxISK.org. The website is “an independent drug safety website set up by the authors and colleagues, offering an adverse event reporting facility which began collecting data on all drugs and all adverse events in 2012.” The website requires voluntary reporters to answer a set of demographic questions, followed by an assessment of causality, based on the Naranjo algorithm, to determine if the reported drug is responsible for the reaction. The following scores denote significance: 0-4 more information is required, 5-8 a likely link between medication and side effect, and 9+ a strong possibility of a connection between medication and side effect. Lastly, reporters rated the impact of the side effects on their everyday life, i.e., physical, mental, work, and social. Data from June 2012-December 2015 and April 2016-August 2017 were analyzed (the missing dates were unavailable due to website maintenance).

The results indicate a mean causality score of “8.9 for serotonin reuptake inhibitors, 8.8 for 5α-reductase inhibitors, and 8.5 for isotretinoin,” from “37 countries across six continents: Europe (137), North America (126), Oceania (15), Asia (14), South America (6), and Africa (2).” The ages of participants ranged from 15-66 years, including 16 cases reporting the onset of the condition beginning at under 18 years of age. Duration ranged from a single dose to over 16 years. In many cases, sexual dysfunction appeared only when the medication was stopped or was further exacerbated upon termination. More details were depicted as follows:

  • 17 SSRI cases report developing premature ejaculation
  • 6 SSRI cases report persistent genital arousal disorder (continuous sense of arousal and discomfort in the genitals, without feelings of desire)
  • 16 cases of decreased testosterone (potentially linked to a pre-condition)
  • 5 cases report the glans of the penis remaining flaccid when the shaft was erect (4 SSRI, one isotretinoin)
  • 2 SSRI cases of onset penile curvature (unknown if treatment-linked or incidental)
  • 6 cases of reduction of nipple sensitivity
  • 15 cases of reduction of other sensations across the body
  • 3 SSRI cases of increasing loss of sexual function as the drugs were tapered
  • 25 cases of relationship breakups due to the disruption of a romantic relationship, 9 of which were marriages
  • 90 cases of work disruption, 12 of whom lost their jobs
  • 17 cases endured the syndrome for at least ten years since stopping treatment (8 SSRI, one finasteride, eight isotretinoin)
  • Cases of fatigue (9%), muscle weakness (3%), and cognitive problems (19%), specifically memory impairment (11%), particularly with finasteride.

The researchers call for next steps, including an investigation of tardive sexual syndromes as well as a systematic approach of patient groups with specific sets of symptoms. Structured interviews are needed to explore case idiosyncrasies, and treatment histories can be used to better inform the causal (or lack thereof) relationship between the medications and side effects.

Healy and colleagues move forward by petitioning for a change to current informed consent practices for these medications. They state that while SSRIs are commonly known to reduce genital sensation, “it isn’t known how many people fully regain their original genital sensation, libido and other domains of sexual functioning after using a serotonin reuptake inhibitor.” Following the work of others who have unveiled this connection or been personally impacted, Healy and other petitioners call for more explicit forms of consent.

On April 23, 2018, Healey and 21 psychiatrists, psychologists, neurologists, practitioners, and other professionals in the field, submitted a petition “to request the Commissioner of Food and Drugs to immediately require the addition of boxed warnings to the product label for all selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) products, including branded and generic formulations. Some of these include, but are not limited to, citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), paroxetine (Paxil), sertraline (Zoloft), venlafaxine (Effexor), and vortioxetine (Trintellix).”

The petitions call for the addition of warnings, precautions, and highlights of prescribing information in an effort to accomplish the following:

  1. “Inform that the use of and withdrawal from SSRIs and SNRIs can result in genital anesthesia, pleasureless or weak orgasm, delayed or absent orgasm, loss of libido, erectile dysfunction, decreased vaginal lubrication, reduced nipple sensitivity, flaccid glans penis during erection, reduced response to sexual stimuli, and decreased capacity to experience sexual pleasure”
  2. “Inform that the use of and withdrawal from SSRIs and SNRIs can result in persistent genital arousal disorder (PGAD)”
  3. “Inform that sexual side effects can sometimes persist for years or indefinitely after discontinuation of the drug; they can emerge on treatment and remain afterward, or emerge or worsen when the drug is stopped.”
  4. “Send all manufacturers of SSRIs and SNRIs a notification letter of the need for a Risk Evaluation and Mitigation Strategy Plan,” requiring manufacturers to send letters to health care provider around the adverse reactions and to develop a ‘Medication Guide and Communication Plan’ for patients.

The signees use case examples to illustrate the point that the current warnings are insufficient. They conclude:

“Without adequate warnings about the risk of potentially permanent damage to sexual functioning, patients are being deprived of informed consent. It is currently impossible for patients and health care professionals to weigh the benefits of treatment against the harms. We therefore request that clear warnings are immediately added to all SSRI and SNRI products.”

 

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Healey, D., Le Noury, J., & Mangin, D. (2018). Enduring sexual dysfunction after treatment with antidepressants, 5α-reductase inhibitors, and isotretinoin: 300 cases. International Journal of Risk & Safety in Medicine, 29(3-4), 125-134. doi: 10.3233/JRS-180744 (Link)

Healey, D. (2018). Citizen petition: Sexual side effects of SSRIs and SNRIs. International Journal of Risk & Safety in Medicine, 29(3-4), 135-147. doi: 10.3233/JRS-180745 (Link)

22 COMMENTS

  1. Do not forget the “antipsychotic”s.

    The psychiatrists says the patient has anhedonia. They don’t feel pleasure.

    This is after they medicated the patient with drugs designed to create dopamine problems in the brain.

    After the persons/patient knows he/she is going to have a horrible life. You don’t feel happy with that knowledge? You don’t have hope? You don’t say…

    Maybe the patient has the symptoms BECAUSE of the diagnosis and the drugs? No?

    • Yes, I believe there must be MANY people who suffer this way after being given neuroleptics, or so-called “antipsychotics”. I am one of them, even though I have been drug free for almost 35 years and have had genital anesthesia and zero libido ever since being injected with Haldol in 1983.

      I have asked some very influential people, including Dr. Thomas Szasz, Dr. Peter Breggin, and Robert Whitaker if they could help me find any studies on this kind of loss stemming from neuroleptics, but none of them could help me in that way. Dr. Szasz (may he rest in peace) was very kind and wrote back to me twice after I told him my story. He said that what I experienced was not uncommon and encouraged me to write a book or short story, about it. ‘Said it might do some good in the world.

  2. Thanks for pointing out these odd sexual effects of the antidepressants, and I agree with Mark, it’s also a problem with the antipsychotics. The psychiatrists have been misdiagnosing the odd sexual side effects of their psych drugs, as the other invalid DSM disorders, for decades. Don’t forget to include the odd sexual side effects of the “happy, horny, skinny drug,” Wellbutrin.

    And I must say intruding into, then messing with or destroying another person’s sex life, thus also destroying an innocent couple’s marital relations, is truly an evil thing to do. I have no idea why today’s “mental health professionals” believe it is their right to destroy other people’s marriages. Truly, today’s highly invasive “mental health professionals” are a menace to society.

    Please do call for black box warnings on all the psychiatric drugs, due to their odd sexual “side” effects. The doctors are still ignorant of this issue.

    • I really do believe that psychiatrists who have prescribed these drugs and dismissed patients’ complaints out of hand (as mine did) should be made to take the bloody drugs for a year or two then have them withdrawn cold turkey.

      After all, they locked many of us up and forced us to take them, refusing to listen to our reports of adverse side effects to the point of having people held down and the drugs forcibly injected.

      It is now getting towards 10 years since I took any of their drugs and even the thought of a sexual relationship is anathema to me, meaning I will likely remain unpartnered the rest of my life (I am in my 60s) Then there’s the trauma directly resulting from being so treated. Yes. I am angry.

      While I do enjoy much life has to offer, intimate relationships, loving and being loved, are now out of my reach as a direct result of psychiatry and psychiatric drugging.

      That they can do that with no repercussions and no forewarning or informed consent amounts to torture.

    • I totally agree with you, mik, and I am angry too. Doctors ignored me years ago when I told them about my numbness and total lack of libido. (I had been forcibly injected with Haldol in 1983, but have been free from neuroleptics since then.) I was told that my lack of libido was probably because I was depressed and that I needed to take antidepressants. I’m glad I didn’t take their advice, but it has been very difficult to live with my loss.

      Perhaps this is why so many people have suicidal thoughts after taking antidepressants. I think it also probable that people who have been given neuroleptics take their lives for this reason. However, those who have been on these drugs for a long time may not be as articulate as those who have only been on so-called antidepressants”. In addition, once labeled psychotic they lose their credibility. No one believes them.

      It is high time that doctors become more receptive to their patients.

      For more of my story you can view my video on YouTube. Be sure to click on “SHOW MORE” to read it all.

      https://youtu.be/-RWvdv9TsrM

  3. Well, that’s good. I have had PSSD post Effexor for 7 years.
    It is a minor problem compared to the PTSD, brain damage, memory loss, cognitive dysfunction I have as a result of electroshock.
    Perhaps Dr. Healy could review the 500 reports filed with ectjustice.com and present the case for banning shock. I don’t need to be viewing junk like Anderson Cooper’s interview with the dazed, confused Kitty D. Which completely minimized the risks and dangers.

  4. I have to say, nothing lifts my depressed mood more quickly than deleting my sex life, disrupting my relationships, and reducing my “quality of life.”

    It continues to astound me that “professionals” continue to prescribe these drugs so copiously when so many people suffer as a result. Some kind of weird disconnect is going on when professionals trying to “treat” depression feel like ruining the patient’s sex life is an acceptable “side effect.”

    • These are not “professional” anything but quacks. They should be wearing Melania’s Jacket “I really don’t care..” bc they don’t. They are ignorant, dangerous, and have Zero clue what they are doing so they simply poison and shock ppl… they belong in prison-

    • Steve: Apart from the fact that Psychiatrists themselves are brainwashed that drugs work, the system does have an inherent disconnect. The way they assess how you are doing is a short interview every so often. If you are having a good day, then “the meds are working”. That periodic interview is not enough to assess mental state. You need a round the clock idea of what’s going on, and that’s where family and carers could help but it does need to be a true open dialogue to preserve trust. The information from the patient themselves is paramount of course, but the doctors tend to put words in their mouthes in one to one chats. Family and carers are regarded as offside potential trouble makers, part of the cause. And this starts to become true once you research and quite objectively conclude the doctor is not telling the truth and is trying to manipulate everyone to create a narrative that the drugs are working. The threats of hospitalization then demonstrate that this is not a team where we are all on the same side, and then you realise that everything you say gets twisted to assist their narrative. The trust in the psychiatrist goes whilst the psychiatrist tries to drive a wedge in the family “why don’t you just trust in me”.

      At that point, the problem is actually the psychiatrist, because he is clearly revealed as dishonest and manipulative, and his obsession with the drugs means that, outside of medication, he’s actually a useless busybody, a dangerous snake oil salesman who has no idea how to make people better.

      The psychiatrist has too much power, and the psychologist, who works for the psychiatrist, just provides more material to be twisted. The system is unfixable until the Psychiatry either embraces psychosocial approaches or psychiatrists are are relegated to the role of pharmacist, or someone assumes responsibility for care who is educated and honest.

      As regards sexual side effects, they say nothing, the patient says nothing, and when you raise the possibility the doctors will then say, “look, it’s obviously all a myth”. The patient will never say anything, and is going through hell on earth anyway so won’t talk about it. The doctors find it very easy to brush this scandal under the carpet.

    • Agreed. I think it goes beyond the sexual and affects all aspects of the life experience: Anhedonia. SSRIs/SNRIs have ruined my life along with trying to come off. It is amazing that my marriage has survived, but I can honestly say that I have never been completely honest with my husband as to the extent to which the anhedonia these drugs have caused impacts. I have not felt a deep connection to him or anyone else for years, and lovemaking is something to be endured, for the fact that I have no libido, lack of sensation or response to touch, very poor quality orgasms etc. It isn’t just about him; I have no fantasies and don’t get turned on looking at other men or thinking about being with anyone else. I find little pleasure in life generally speaking. It is really a rather tedious existence. No sense of satisfaction in life, joy to be alive. We only have one life to live, and it is unbearable to think of all the years I allowed these drugs to ruin me, that I don’t get back. I lost the prime of my life. I continued taking them because I believed the lie. If only I’d known in advance…

  5. Thank you very much for this article. This is the first time I have read scientifically about PGAD in connection with antidepressants and their side effects.

    For years I have been writing at the German ReGS (Restless genital syndrome = PGAD) forum and try to explain that this is a highly traumatized state of the nerve and endocrine system in humans in connection with altered states of consciousness.
    I estimate that 80% of the members on this forum suffer from depression and take antidepressants or have discontinued them. Some have suffered for years from this condition of PGAD to varying degrees. So now they get antiepileptics, antipsychotics or again antidepressants prescribed by their doctors.
    I experienced similar descriptions at the Dutch „PSAS forum“ and at the American “pudendalhope forum”.

    In Europe, Prof. Waldinger in The Hague is doing research on PGAD, but unfortunately he “believes” in Tarlov cysts, pudendal neuralgia, hormonal disorders and other completely absurd disorders in this context. I wrote him a detailed letter in 2016 hoping that he might change his meanings, but a discussion between a Professor and „simple“ people in Europe about medical questions seems to be impossible.
    So nothing in Europe is moving into a right direction and most of the doctors have no idea what PGAD is and what it means to live with such a condition.

    So I would like to lose some more lines about this for humans unbearable condition.
    All the scientific reports I have read, especially on the Dutch forum, which has listed some articles, deal with a condition and believe in a measurable physical cause. At the same time I assume that nobody can understand what it means to live with such a condition for years. After the depression, which should be “cured” follows a never-ending hyper traumatization. Any kind of sexuality aggravates the condition and drives on the autonomic nervous system. People no longer sleep because of the constant “fight or flight” condition. So they have to use drugs again to get a few hours of sleep, because at some point they can no longer bear the sleepless nights. They lose their work, their social contacts and sometimes also their partnerships. Life is destroyed!

    I have the hypothesis, and I know that it is correct that this type of “sexuality” is happening in an altered state of consciousness caused by trauma and antidepressants. This is also supported by the fact that mild trance states, such as driving a car, watching television, any kind of focusing, intensifies the symptoms. On the other hand, distraction and “forgetting” the feelings almost makes the symptoms disappear.

    I go one step further, it is an energetic problem reinforced by thoughts and the terrible feelings themselves.
    These feelings are not in the body, they are „phantome feelings“. The trauma researcher Robert Scare compares psychosmatic pain with phantome feelings when a limb is amputated. He says, phantome feelings are a prototype of psychosomatic disorders. PGAD produces phantome feelings. The patient with PGAD is feeling a „phantome sexuality“ and „phantome pain“. Trauma researchers also say that psychosomatic pain is more intensive than somatic pain.

    Dr. Joe Dispenza has just published his new book “Becoming Supernatural”. Of course, he’s in the esoteric corner of the bookstore. For me he provides a plausible model of the physiology of altered states of consciousness. It describes a certain way of meditation with a certain breathing. If this path is negatively influenced, such as by trauma and antidepressants, I think it is possible that this energetic physiology causes altered states of consciousness with terrible, negative feelings. Everything has a lot to do with breathing. We know that traumatized people breathe differently. Peter Levine says that trauma is stored in the diaphragm and I say also in the pelvic floor.

    These antidepressants are much more dangerous than visible to others from the outside. They destroy lives and that is not exaggerated because there is currently no possibility of help. Every psychiatrist has to know this clearly and if they screwed up the treatment, they have to tell the patient. Responsibility is the magic word. Anyone who works with mind-altering drugs must know that they can destroy lives. These doctors have to know that PGAD is not a „sexual dysfunction“, it is the destroying of human life from the radix of all life, from sexuality. I want to make a difference because it is not a disorder as usual, it is a daily trauma and torture.

    I am glad that the research continues.

  6. I hope that those of you with personal or professional knowledge of the deceit/manipulation of the pharmaceutical model in treating psychiatric disorders become driven to expose the lies by any and all means. Please consider joining the Citizens Commission on Human Rights who is in the process of collecting complaints regarding the abuse and fraud that the psychiatric/medical community is foisting on unsuspecting individuals, especially those within the mental health facilities . Their goal is the restoration of human rights in the mental health field where egregious violations are occurring in the area of informed consent regarding the long-term effects of these drugs/therapies. The CCHR has offices worldwide and would welcome your input/assistance with this project. Please lend your voices to this vital cause. Thank you.

  7. I would like to see some studies about sexual dysfunction from neuroleptics; not just erectile dysfunction in men but genital anesthesia and lack of libido in both men AND women. My channel and text video on YouTube tells my story. Here is the link to it:

    https://www.youtube.com/channel/UCZaVF8gOXTNt-d9hq1el9xQ

    …and here is a copy of the rest of my story seen underneath my video if you click on “SHOW MORE”:

    “I am what is known as a psychiatric survivor. I’ve had three breakdowns, each occurring after PROLONGED SLEEP DEPRIVATION. I was forced to take neuroleptics (or so-called “antipsychotics”) each time, but have been off of them now for over thirty three years. The problem is that, even though I took these drugs for very short periods of time, they left me with permanent damage.

    My first breakdown came in 1975, before I had any children. I was on Haldol and Cogentin for about four months, then took myself off these drugs after the psychiatrist refused to do it, telling me I would have to be on them for the rest of my life. After I went off of them I realized that I had lost the feeling in my saddle area that made it possible for me to become sexually aroused. My bottom felt cold and numb. I also didn’t understand why I couldn’t feel when I had to urinate until there was strong pressure in my abdomen. I wondered if this numbness would be permanent, but was relieved when, after two years, the feelings came back to some degree. (However, they were never to be as strong as they had been.)

    Well, time went by. I married and had two children, one in the hospital and one at home, both without anesthesia. The feelings I had seemed intact until about a month after my second child was born in 1981. I was a nursing mom, did my own diapers, and worked very hard, often into the night. My baby seemed to have colic, both of my children woke me up over and over at night, and I could not get them to sleep at the same time during the day. So I didn’t sleep for about a week.

    I started to exhibit psychotic symptoms again, was taken to the hospital, forcibly drugged, and labeled a “chronic paranoid schizophrenic”. Again I took the Haldol and Cogentin for a couple of weeks, then flushed it down the toilet. Again I lost all my sexual feelings and had to remind myself to urinate.

    After a couple of years I began to feel just a little. Then a major family crisis came along in 1983 over which I again didn’t sleep for about a week. I would have taken a sleeping pill if I could have, but did not have the opportunity until it was too late. By that time I thought I could do anything. I felt like a superwoman. Well, I was only in the hospital for three days, and I immediately flushed the Haldol and Cogentin down the toilet when I got home, but it was too late. I felt as though I had sat on a big piece of ice that I couldn’t get off of, and it wouldn’t melt. ‘Still feels like it never will.

    I have (literally) sat on this secret for over thirty-three years. At first I thought it must be psychosomatic, something having to do with my anger, and went though extensive therapy. Then, in 1993, I found an M.D. who would actually listen to me, and he put me through some medical testing. When he had finished he told me that I had apparently lost the feeling in my saddle area. In other words, I have a permanent saddle block, or PERMANENT GENITAL ANESTHESIA.

    I am blessed with a wonderful, understanding, husband, whom I’ve been married to for almost thirty -nine years. We have two grown children, who are both married, and four wonderful grandchildren. I’m AMAZED, because I was once afraid to marry and have children.

    As I was working toward my BA in Psych, I was told that mental illness is inherited. Yes, it did seem to run in my family. My great grandmother died after living in an institution for twenty-three years, and my mother was on psychiatric drugs most of her life until she developed symptoms of Tardive Dyskinesia (brain damage) from them several years before she died.

    I thank God everyday for my family, but I believe that it is important for me to share my story with the public now because so many young people are being given the drugs I was given, and other similar ones. I have heard about people who are on anti-depressants reporting permanent sexual side effects, but I wonder how many have experienced them after being given the major tranquilizers (neuroleptics). The damage that these drugs have done to me has been DEVASTATING.

    Is it any wonder that there are so many angry, violent, depressed, and suicidal young people when so many of them are being put on drugs they can’t “say no” to?

    Country: United States
    Occupation: Retired Montessori Teacher”