Regulations.gov (2018)

Regulations.gov is a U.S. Federal government web site that acts as an "Internet portal and document repository" that allows members of the public to participate in the rulemaking processes of some Federal government agencies.
The site allows users to make public comments in response to notices of proposed rulemaking issued by participating agencies; such comments become part of the public record and may be displayed on the site.



Requests that the FDA immediately require the addition of boxed warnings, warning, preacautions, and highlights of prescribing information to the product label for all selective serotonin reuptake inhibitor and serotonin-norepinephrine reuptake inhibitor products, including branded and generic formulations to warn of serious and severe risks.




Primary Documents (3)

Citizen Petition from Data Based Medicine Americas Ltd
 undefined
    • Other
       
    • Posted:
       
      05/11/2018
       
    • ID:
       FDA-2018-P-1846-0001

    Interim Response Letter from FDA DDM to Data Based Medicine Americas Ltd
     undefined
      • Other
         
      • Posted:
         
        11/07/2018
         
      • ID:
         FDA-2018-P-1846-0092

      Acknowledgment Letter from FDA DDM to Data Based Medicine Americas Ltd
       undefined
        • Other
           
        • Posted:
           
          05/11/2018
           
        • ID:
           FDA-2018-P-1846-0002


        Supporting Documents (58)






        Comments (35)

          Comment from Luke Petropoulos
          • I am a 20-year-old male suffering from persistent sexual dysfunction after tapering off of 10mg citalopram nearly 2 years ago. My symptoms include erectile dysfunction, genital anaesthesia, reduced libido as well as impaired memory and emotional bluntness. My symptoms are very severe, having had my sexuality transition from being very potent to nearly eradicated in a short amount of time. The glans is so desensitised that it is unable to feel any pleasure at all. I experienced numbness in my genitals after the very first dose of citalopram but did not experience erectile dysfunction or reduced libido until withdrawing from the drugs. The numbness also became significantly worse.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0072
          Comment from Anonymous
          • please check the pssd peoples microbiome, there are over 5000 people destroyed live and nobody do something about !!!!! http://www.pssdforum.com
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0068
          Comment from Anonymous
          • SSRI's ended my sex life at the age of 22. I am female and previously had a completely normal sex life/sex drive. Within one week of Citalopram I lost all sexual feeling - sexual touch felt no different to someone touching my hand or my elbow. I could still feel the touch but there was nothing sexual about it, and no possibility of reaching orgasm. I assumed this would stop when I stopped taking the drug, which I did six months later. But 9 years later and my symptoms have not improved.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0082
          Comment from Anonymous
          • I am a 20 years old male with persistent severe sexual and psicological dysfunction after taking paroxetine for 2 weeks ( 10mg for the first week, 20 mg in the second) and vortioxetine for 4 days ( 5 mg). All of this was happening seven months ago. My life is now destroyed, both on social relationship side and job management side. All of this thanks to SSRIs' "therapeutic effects". Condiotion worsened after withdrawal.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0087
          Comment from Anonymous
          • Dear Sir or Madam, it is known that SSRIs can often cause sexual dysfunction (Higgins et al., 2010: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3108697/ ) and the SSRI Dapoxetine is developed specially for the treatment of premature ejaculation. SSRI-induced ejaculation delay occurs in 70-80% of men (Waldinger, 2015, 3.1.1.1: https://www.ncbi.nlm.nih.gov/pubmed/26579971?dopt=Abstract ). Though SSRI-induced sexual dysfunction doesn't always go away after the discontinuation of the treatment (Post-SSRI Sexual Dysfunction) (Waldinger, Handbook of Clinical Neurology, 2015: https://www.ncbi.nlm.nih.gov/pubmed/26003261 ) (Healy, 2018: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6004927/ ). In some cases, other SSRI-induced side-effects like SSRI-induced emotional blunting can persist as well (Stinson, 2013, 105ff. & 139: https://ir.uiowa.edu/cgi/viewcontent.cgi?article=5061&context=etd ) (Healy et al., 2018: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6004900/ ). The DSM-5 and the Prozac prescribing information already mention this (Healy, 2018: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6004927/ ). A very important aspect is that SSRI-induced sexual dysfunction can not be compared with conventional sexual dysfunction. Reduced genital sensation is a characteristic and common side-effects of SSRIs (Healy, 2018: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6004927/ ) (Bahrick, 2008: https://benthamopen.com/ABSTRACT/TOPSYJ-1-42 ) and it is a common symptom of Post-SSRI Sexual Dysfunction, too (Ben-Sheetrit, 2015: https://www.ncbi.nlm.nih.gov/pubmed/25815755 ) (Waldinger, Handbook of Clinical Neurology, 2015, 481: https://www.ncbi.nlm.nih.gov/pubmed/26003261 ). Also delayed ejaculation/orgasm is very often associated with SSRIs (Balon, 2006: https://ajp.psychiatryonline.org/doi/full/10.1176/ajp.2006.163.9.1504 ). Regarding PSSD-sufferers genital anesthesia and delayed ejaculation occur about as frequently as conventional sexual side-effects like erectile dysfunction (Healy et al., 2018: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6004900/ ) (Ben-Sheetrit, 2015: https://www.ncbi.nlm.nih.gov/pubmed/25815755 ). This indicates that Post-SSRI sexual dysfunction is neither a conventional type of sexual dysfunction nor sexual dysfunction caused by depression. Conventional sexual dysfunction or depression are not associated with genital anesthesia (Bahrick, 2008: https://benthamopen.com/ABSTRACT/TOPSYJ-1-42 ) (Reisman, 2017: https://www.ncbi.nlm.nih.gov/pubmed/28642048 ) or delayed ejaculation/orgasm (Balon, 2006: https://ajp.psychiatryonline.org/doi/full/10.1176/ajp.2006.163.9.1504 ). The retrospective design of the studies is no reason to doubt the high frequency of genital anesthesia as it isn't likely that many more PSSD-sufferers who do not have genital anesthesia, but suffer from erectile dysfunction, wouldn't care about their situation. Moreover, a lower frequency of genital anesthesia would still indicate that the sexual dysfunction has been caused by the SSRI due to the mentioned reasons. Eventually I want to quote Prof. Waldinger: Prof. Waldinger (2014): " 'PSSD is a very serious problem,' said Professor Marcel Waldinger sexual psychopharmacologist at Utrecht University. 'Often it does not come to light because people do not talk about their sexual problems as quickly. Psychiatrists and family doctors send patients usually away with the message that the drugs cannot do this. During lectures they react often shocked when I tell them that it is indeed possible.' Waldinger has had a number of these patients in his practice, he says. 'Ive studied them extensively. Their symptoms are most likely caused by SSRIs. All other explanations, such as that caused by the depression or relationship problems, we have excluded ' " http://www.volkskrant.nl/vk/nl/2672/Wetenschap-Gezondheid/article/detail/3610672/2014/03/11/Gebruik-antidepressivum-kan-libido-slopen.dhtml Yours sincerely
          • Public Submission
             
          • Posted:
             
            11/28/2018
             
          • ID:
             FDA-2018-P-1846-0095
          Comment from William Gallaher
          • The scientific literature and adverse drug reaction data clearly show the existence of persistent sexual disorders as a possible outcome associated with SSRI and SNRI medications. My quality of life has been severely deteriorated by such an adverse drug reaction and there is currently no way to ameliorate these effects. It is imperative that consumers are informed of this risk of persistent sexual dysfunction prior to taking any SSRI or SNRI medication and a black box warning would sufficiently address this.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0086
          Comment from Anonymous
          • I was prescribed a few antidepressants for brief periods between 2007 and 2010 due to a problem with anxiety, giving up each time after a month or so when the drugs did not help. I took Zoloft initially, and then a couple years later Effexor and then Celexa. I still remember the first doctor saying the best thing about Zoloft was that it was safe. There was no mention of side effects, so when I suffered from ED during the treatment, and premature ejaculation afterwards, I didn't even connect the two, but those things shouldn't spontaneously occur in a young adult. A few years later when I sought help again, I eventually made the connection between ssri's and sexual side effects. Of course, I still had a lot to learn. There is a condition called Post-SSRI Sexual Dysfunction (PSSD), which I discovered with horror while wondering why I was still suffering side effects from Celexa after ceasing to take it. Many doctors aren't aware of or refuse to recognize it. But 8 years after a month of 10mg/day of Celexa, I still suffer from genital anesthesia, low libido, and anhedonia. Pretty much every aspect of my sexual functioning is reduced or gone. I feel an emptiness in the area of my genitals as if their connection to my brain has been severed. Additionally I have a lack of appetite and thirst, as well as premature ejaculation which I believe was from the initial course of Zoloft. I stopped working in 2011 to focus on my health, and have still not found any relief.
          • Public Submission
             
          • Posted:
             
            11/28/2018
             
          • ID:
             FDA-2018-P-1846-0094
          Comment from S
          • Would like to show my support for this regulation. I was not aware of the sexual side effects related to taking SNRIs and would likely have chosen a different medicine had I known.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0089
          Comment from Anonymous
          • Good morning, I was treated for 5 years with SSRI's (paroxetine and fluoxetine). During the treatment I experienced side effects on the sexual sphere (loss of libido, lack of genital sensitivity). Unfortunately, at 5 years from the interruption of treatment, these symptoms have not resolved and the situation has not returned to normal as would be expected since I do not have organic pathologies that can justify these symptom's persistency, that can be assumed to derive entirely from the previous treatment with SSRI's. I think it is urgent a review, especially in the long term, of the evolution of these disorders that are presented by many people during treatment with SSRI's, but on which there are no longitudinal studies that evaluate the possible resolution, once the treatment is interrupted .
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0067
          Comment from Anonymous
          • Developed sexual dysfunction after discontinuing generic paxil (paroxetine). It was mild until discontinuation, and has persisted ever since. This includes numbness, erectile dysfunction, premature ejaculation, and complete ejaculatory anhedonia. A complete loss of sexuality.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0078
          Comment from Lori Anderson
          • I would like to add my name to the list of those who developed PGAD after going off an antidepressant. It happened to me twice, three years apart. People need to know how horrible this condition is and should be fairly warned about it before they take these medications.
          • Public Submission
             
          • Posted:
             
            09/19/2018
             
          • ID:
             FDA-2018-P-1846-0063
          Comment from Michael
          • To whom it may concern, I am an otherwise healthy male at the age of 35 that is suffering from persistent SSRI related side effects and/or drug induced damages directly caused by Lexapro (escitalopram). I was diagnosed with generalized anxiety and social phobia in my 20s. Like all too common, I was told I have a chemical imbalance in my brain related to serotonin (never tested or proven in any way) and that I need to be on SSRI medication for life to deal with the symptoms). Roughly 2 weeks into treatment, escitalopram made me completely imponent, removed all libido and made me unable to climax due to reduced genital sensation. I started on Lexapro in the winter of 2010 and did not come up until the summer of 2016. I took all medications as directed by my doctor. During this course of treatment, the sexual side effects induced by escitalopram were managed with Cialis throughout the course of treatment. Additionally, the psychiatrist attempted to add Wellbutrin as well as Mirapex (never together), to counteract the side sexual side effects with limited success. In the summer of 2016, I got married to the love of my life and I wanted my libido back and my normal sexual functioning back. However, my sexual functioning has not returned. I must note that one of the reasons I put up with the sexual dysfunction was because I was told I can stop at anytime and return to my baseline in case I wanted to have children, etc... Over 2 years post cessation of all medications, I remain completely impotent (I have to inject my penis to have an erection to make love to my wife and I cannot climax or enjoy this sex at all). Aside from total impotence, I also have zero libido, numb genitals-hands-feet, anorgasmia, reduced ejaculate (when I can ejaculate which is not often), testicular atrophy, shrunken scrotum, constant and sometimes debilitating headaches and pressure in my head, cognitive issues, complete anhedonia (cannot cry, cannot feel emotions of any kind including even what I was put on the medications for to begin with (anxiety)). These drugs have made me asexual and have chemically castrated me (potentially for life as I have not improved at all in 2 years). I was old enough when put on these medications to know what my normal libido is. Even when my anxiety was at its worst, my genitals were never numb and I could still experience sexual pleasure. Oh, I also have measurable neuropathy in my feet. I had an EMG done and ALL known causes of neuropathy were ruled out (e.g., diabetes and vitamin b deficiencies). These drugs caused the neuropathy, because for a certain % of the population, they are neurotoxic. This condition is nothing short of pharmaceutical rape. I urge the FDA to seriously consider Dr. Healy's petition and place black box warnings on all of the drugs listed in his petition. If any additional information is needed, please feel to contact me privately. Thank you.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0074
          Comment from Anonymous
          • Use of SSRIs and SNRIs has had no impact on my sexual health. I have been taking Zoloft for almost 4 years now and noticed no difference. However, before Zoloft, I tried two other medications, one of which was Lexipro. This medication had an effect on my sexual arousal. It is one of the reasons that I switched to Zoloft.
          • Public Submission
             
          • Posted:
             
            09/19/2018
             
          • ID:
             FDA-2018-P-1846-0062
          Comment from Shawn
          • I took Citalopram and later Sertraline at a young age and everything changed. Both of these drugs had a huge negative impact on my sexual functioning and emotional development. I'm in my early 20s now and its been years since ive come off these drugs yet i continue to have severe sexual dysfunction, testicular atrophy (which was confirmed with an ultrasound) that the doctors have no explanation for, unexplained hormonal imbalance, emotional numbness and other disturbing symptoms. I know SSRIs are the cause for these symptoms (known as "PSSD") as I was a relatively normal, healthy teen who had moderate anxiety issues and no clinical depression before the use of the drugs. I took them as prescribed and always followed my psychiatrist's advice, but I had to come off as I realized these side effects were not going away on their own. Upon withdrawing my problems only worsened and has remained just as bad if not worse today. I wish I had never, ever touched these medications. I ask you to please do more research on the sexual and emotional side effects of these medications, and to give appropriate labeling/warnings when prescribed. The most frustrating part of this experience is not having anyone believe me. Doctors have no answer for me, they can't tell me why all these things are happening to me, yet don't want to accept my experience that SSRI's are the cause for all of this. I know SSRI's are the reason for my health problems, and for the health problems of many others. Please take appropriate action. Thank you.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0070
          Comment from Mary Koback
          • PSSD is the worst thing that can happen to a person. After taking Zoloft, my genitals felt completely numb and my emotions completely disappeared. I went from being a sexual, outgoing, cheerful person to having 0 emotions and 0 sexuality. In addition to all of the terrible withdrawal symptoms I experienced (and am still experiencing at over 2 years off zoloft), PSSD has ruined every aspect of my life. Thanks for listening!
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0076
          Comment from Anonymous
          • I was diagnosed with Generalized Anxiety Disorder in my early twenties. I was placed on a variety of SSRIs and SNRIs over a period of time in an attempt to treat that, both by GPs and by psychiatrists. During the course of my treatments with SSRIs and SNRIs, I suffered from total sexual dysfunction (arousal; erectile dysfunction; etc.). I understood that to be a side effect of the treatment, and was warned as much. I was never warned or informed that those side effects could persist following treatment and cessation of administration of SSRIs/SNRIs, either for a period of time, or (apparently) permanently. I continue to suffer from sexual dysfunction over four years following my last dose of a SNRI (Pristiq). My sexual function was completely normal prior to taking SSRIs/SNRIs. The consequences of my sexual dysfunction on my quality of life have been severe. I have an impaired ability to initiate relationships with people, and have had trouble maintaining relationships. My inability to relate to a romantic partner in an intimate way has devastated my belief in my long-term prospects of ever finding myself in a relationship. I have developed suicidal ideations as a result of this, where I was previously quite content with life - despite my anxiety. Sexual function is a fundamental human function, and plays a pivotal role in fulfilling what is a primal but essential need to bond and to relate to another romantic partner. I feel robbed of the ability to do that.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0085
          Comment from Michael Farrill
          • I unfortunately have had persistent sexual side effects since stopping SSRI's 15 years ago at age 21. My sensation, response, and libido have not returned to normal and it has impacted my relationships very negatively. I had taken SSRI's for 3 years (first paxil, and then effexor consecutively) and was expecting to returning to my baseline virility after stopping. This never happened, and I hope that the FDA will put a strong warning on these medications so that patients can make informed choices. I for one would have avoided the medications had I known these lasting side effects were a possibility.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0075
          Comment from Brooks Witzke
           undefined
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0064
          Comment from Spruce
          • I first took Citalopram in November 2007 to treat OCD. On taking the Citalopram within a day it had completely wiped out my sex drive, caused me to have numb genital, and pleasureless orgasms. I last took the drug in January 2009. The Citalopram did nothing to help my OCD. I have been off the drug nearly 10 years and still have zero libido, numb genitals and pleasureless orgasms. Living with PSSD is a living hell on earth. It has ruined two relationships I have had, and has stopped me being able to have normal sexual relationships with women, and has nearly driven me to suicide. It has also affected my life in many different ways which I won't go into in this comment, as I would be here all night. Everyday of living with this condition is a mental torture. PSSD has caused me more misery, pain and suffering than any other experience I have ever had, even if you were to add up every other bad thing that has ever happened to me collectively. Doctors don't want to believe PSSD exists, and can get quite nasty when you try and tell them you have developed the condition. They don't want to know. I have had no support or understanding from the medical profession what so ever. This is a very common experience for people suffering from PSSD. It is long past time something is done about this long lasting living hell of a condition.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0083
          Comment from Anonymous
          • I used an SSRI (Citalopram) for 12 months ten years ago and it destroyed my sex drive permanently and made me impotent. To this day i am basically asexual. Before the med i always had a very high sex drive.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0080
          Comment from Dillon
          • Pristiq (desvenlaxfaxine) has absolutely destroyed my sexual function. I came off the drug in August of 2016, due to the sexual side effects experienced on the drug (no libido, erectile dysfunction). I hoped that things would improve after the drug completely left my system, but here I am over 24 months later, with absolutely zero improvement. I have had all relevant blood tests, etc. All results are normal. Every avenue has been explored, and there is no sign of any hope for a fix for these issues. This has decimated my relationship, and had an extremely negative impact on my overall well-being.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0065
          Comment from David Healy
          • There is one further detail not made clear in our original submission, but which we did make in a subsequent petition about post retinoid sexual dysfunction. This is that of those who have registered with RxISK and reported having Post SSRI Sexual Dysfunction or Persistent Genital Arousal Disorder (post SSRI), we have over 60 people who are willing to share their name and further details with FDA of which over half indicate that they can get their doctor to endorse their condition as being likely linked to treatment. We are aware that one of the possible blockages in the way of FDA recognising this condition and its link to treatment is when reports are anonymous and you are unable to follow the cases up to establish causality. This led me to write to those who have reported their problems to us and the positive response from over 60. Responses are still coming in. We would be happy to provide details on request.
          • Public Submission
             
          • Posted:
             
            11/28/2018
             
          • ID:
             FDA-2018-P-1846-0096
          Comment from Anonymous
          • I am one of the many unfortunate persons who got a prescription for a life and mind-destroying antidepressant for only a situational issue, being completely healthy, successful and well-functioning young woman before this horrible medication.During a breakup with my boyfriend in 2015 I went to a psychiatrist to speak about my relationship issues.After only 4 occasions she gave me a prescription for generic escitalopram without giving me any diagnosis.She didnt tell a word about side effects or about the risk of possible permanent damage this medication causes.I read the leaflet, but the list of side effect was relatively short.I only found out later it is because its extremely deficient and misleading. I took 5 mg for only a 3 weeks time period.First day I noticed my face was slightly swollen.I called the psychiatrist but she told me to keep taking it.Literally overnight on the 2nd day I lost completely my libido.I felt some slight pain in my genitals and after that they went completely numb.It was like someone cut the nerve connection between my brain and every erogenous part in my body.As this side effect wasnt tolerable, I decided to stop this drug after 3 weeks.3 weeks after stopping absolutely nothing changed in the sexual side effects:I had no libido, no sensitivity, no feeling, no functioning.I also felt very numb emotionally and started to experience severe withdrawal effects: I lost completely the ability to feel any human emotion.I couldnt feel love, excitement, enthusiasm, desire, nothing.When I wanted to cry I felt a strange, strong pressure in my head what made it impossible.I felt a pressure in my forehead area 0-24 which got stronger when I tried to feel any emotion or tried to think, as if that part of my brain was completely dead, paralyzed and inaccessible.I lost my fantasies, my creativity, my visual imagination, stopped dreaming at nights, my mind became completely blank and empty.I experienced severe cognitive and concentration impairment (couldnt process how to do simple things in my work what I did for years before, couldnt understand what I was reading or listening, had to re-read every row 5x, 10x, but still couldnt process it), got severe memory problems, inability to focus on anything, slowed thinking, lost my planning and executive functions, suffered constant mental tiredness and dementia type issues, handshakes, severe and long-lasting chronic fatigue syndrome with constant tiredness, extreme physical weakness, exhaustion, insomnia, irregular heart beating, low blood pressure, very cold limbs and cold genital area, irregularities in menstruation, constant nausea and dizziness, gastrointestinal issues, flu like symptoms, inability of feeling hunger, weight loss, skin issues, extreme severe hair loss known as telogen effluvium (like someone who had chemotherapy, I lost half of my hair in just 9 months after escitalopram poisoning).I felt that my brain is barely awaken during the day, I had terrible brain fog every day.I also got severe amotivational syndrome and total apathy as a consequence of losing my human emotions.I noticed I cant feel any effect from coffee and alcohol in my brain anymore.And in addition to the above, all sexual side effects continued. As a result of this chronic injury I lost my dream job, my career, my financials, my health, and my life as I used to know.I spent a huge amount of money on doctors, tests, treatments, a multitude of supplements and vitamins, but I still have persistent symptoms 3,5 years later.Apart from the permanent complete chemical castration and anesthetized genitals known as PSSD (Post-SSRI Sexual Dysfunction) I am still left with a chemical brain injury characterized by brain fog, slowed thinking, loss of cognitive functions, attention and memory problems as well as emotional blunting and chronic fatigue. I am part of an international PSSD study, the researcher pointed out to that this syndrome is most likely caused by SSRI induced neurotoxicity/toxic encephalopathy.I did a qEEG test around 2,5 years out which shows significant slowing in all my frontal and limbic lobe area which is consistent with a traumatic or toxic brain injury.PSSD is considered currently as a permanent iatrogenic damage, there is no treatment or cure for it.It is not less but a complete chemical castration and lobotomy.There are many theories how antidepressants cause this: neurotoxicity, activation of 5ht2a/2c receptors, loss of SERT and permanent 5ht1a receptor desensitization, inhibition of pudendal C-fibers, ion channel changes, destruction of endocrine and neurosteroid system, damage to dopamine receptors, gene expression changes, structural damage to brain, peripheral neuropathies etc.I never gave an informed consent to risk any permanent brain injury.Psychiatry and the psychiatric drug industry irrevocably and severely violated my basic human rights.Please DO NOT ALLOW THIS TO HAPPEN TO ANYONE ELSE and please find a CURE for the victims.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0071
          Comment from Daryl Brown
          • I can not even believe this horrific harm of permanent sexual impotence, Post-SSRI Sexual Dysfunction (PSSD) was given to me by antidepressants. This happened without informed consent and protection as I was prescribed antidepressants compulsory attending a child mental hospital as a 10 year old child as medications I should be taking for life. My mum has said If she had been given informed consent and had known that antidepressants could cause permanent sexual dysfunction either on the leaflet or warned by professionals she would never have agreed to it. Instead the prescribing doctors and psychiatrists instructed and said that 'There is nothing to lose because if there are any side effects they will all be completely resolved as soon as you stop taking the antidepressant medications'. As a disabled person I feel targeted and deeply dehumanised and degraded for not having received informed consent about permanent sexual dysfunction from antidepressant SSRI drugs. It continues to have a deep and traumatising impact on my life every day, it has changed my life beyond recognition and robbed my self esteem and dignity and enthusiasm for life. The depersonalisation is beyond anything that I have suffered with, a lot more damaging than severe Tourette's Syndrome and OCD. I was put on antidepressants as a 10 year old, and by the time I entered adult life at 21 years old my genitals lost sensation beyond recognition and stopped responding to the natural human arousal response and will not even hold an erection or achieve a full erection. I have been off antidepressants 8 years now and the permanent impotence caused by the antidepressants still remains just the same. I will be approaching 30 soon and this is not likely to change. It has not only destroyed my life, but the family around me, more than severe Tourette's Syndrome and OCD ever has or could. Me and my family were denied the informed consent able to choose between the benefits and the harms. When I withdrew off the antidepressants because of it causing impotence it actually caused Persistent Genital Arousal Disorder (PGAD) to my genitals, uncontrollable and unwanted and overwhelming spontaneous full erections and orgasms in public, until that period subsided and the full blown impotence returned. This is the undoubted proof of how I know the antidepressants were interfering with my sexual function and caused permanent impotence to me. This has destroyed who I am along with my humanity. I can't believe it was allowed to happen to me. And I hope that informed consent is put right for other disabled people.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0073
          Comment from Dr. Todd White
          • I took Citalopram for six days and have lost my ability to get an erection. Nine months have passed since those six days which are days I will never forget. I was suffering from bad anxiety and insomnia at the time but the damage those conditions have done to my life are far outweighed by the seemingly permanent sexual side effects inflicted from just six days of citalopram use. I no longer get spontaneous erections or morning erections. While my libido remains, the brain-body connection with erections has been destroyed by this medication. I feel absolutely betrayed by the medical community. Neither the sleep specialist, my clinical therapist, or my primary care physician warned me that these drugs could destroy my sexual function and that the effects could persist even after discontinuation of the medication. I did not receive adequate information as a patient. I also have numerous physicians in my family and none of them knew about PSSD (post-ssri sexual dysfunction). Physicians are not currently able to explain the far-reaching and life-altering consequences of permanent sexual dysfunction that these drugs pose. My life has been permanently altered by a brief trial period of citalopram. As a PhD holder, I am aware that the literature on PSSD is growing. I truly hope the best interests of patients can be served by receiving proper warnings. People with anxiety and depression entrust their well being to doctors prescribing these medications. They should no longer be kept in the dark regarding the potential for permanent alteration of their sexual health through trials of these medications. It is time to make things right and make sure patients know the consequential risks these drugs pose.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0077
          Comment from Tony
          • Hi I started taking Zoloft when I was 14 years old and have lost my sexual functioning since and I am 24 years old now. Please warn people that this can happen to them. I was just a young boy and was confused about what was happening to me please out of the goodness of your hearts help us.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0090
          Comment from W Cale
          • I was on Prozac for 14 years. Prior to Prozac at age 30 I had never had a sexual dysfunction, but once I started genital numbness came on within the first day. I had sexual dysfunction that got gradually worse. My wife and I found that I was for the most part normal and could function if I skipped Prozac for a targeted day. Eventually we decided to discontinue it and after 3 days I became impotent completely. After 14 years I have not regained any great deal of my sexuality, and remain afflicted. Some feeling has come back and I have regained the ability to feel orgasms after 12.5 years. Erectile function has not returned without medication such as Viagra after 14 years.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0084
          Comment from Oscar Venz
          I got pssd after one tablet of zoloft (sertralin) and suffer really bad from it. 3 month have passed since then in which I havent touched this medication again. My symptoms haven't improved since then. My symptoms are: erectile dysfunction, genital anesthesia and a general loss in sex drive.
          • Public Submission
             
          • Posted:
             
            11/05/2018
             
          • ID:
             FDA-2018-P-1846-0091
          Comment from Carlota Pereira
          • I am here to warn about the danger of ssri/snri. I have been suffering from pssd ( post ssri sexual dysfunction) for 1 year and 8 months because of duloxetine. Basically, no sexual arousal, genital anhestesia, no sexual response, people need to be warned about the possibility of becoming asexual after antidepressants and something needs to be done about it !! Im 21 years and my sexuality was completely erased...
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0069
          Comment from Anonymous
          • My PGAD symptoms started after 2 weeks on an antidepressant that was prescribed for nerve function. It was the day before Easter and I spent the holiday crying in pain and discomfort in my room while my family nervously held the holiday outside. I couldn't walk, stand, or sit in comfort, and sleep was near impossible with constant, intrusive feelings. I have had to pay thousands out of pocket for treatments and medications to give me any relief. I was suicidal. I would never have taken that medication if it had a warning that this might happen. It's been 7 months and I'm still struggling.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0079
          Comment from Alp eke
          • i am severely disabled by short term low dose of ssri use pssd akathasia and of course insomnia i am burning all the time my hands and feet are numb
          • Public Submission
             
          • Posted:
             
            11/28/2018
             
          • ID:
             FDA-2018-P-1846-0093
          Comment from Micha
          • I've been suffering from PSSD (lack of libido being the worst) over 5 months after dicontinuation of mix of psychotropics - one of them being venlafaxine (SNRI), other buspirone.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0088
          Comment from Anonymous
          • An antidepressant drug (citalopram) ripped my sexuality from my body about 5 years ago when I was 26, and I did not find it again after the suspension. The body that no longer responds to mental desire and any sexual stimulation is an aberrant condition. It is urgent to recognize this potentially irreversible chemical castration, as a possible consequence of the use of SSRI / SNRI drugs. It is essential to warn future patients that they can consciously choose. Personally I hope that the official recognition will quickly lead to a series of studies aimed at understanding the etiology and finding a cure, even if only palliative.
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0066
          Comment from Brenda Shannon
          • I have been diagnosed for 18years with chronic intractable pain due to failed spinal fusion surgery and failed revision spinal fusion thearepy. I have gone thru many forms of medical procedures, cbh, acupuncture,epidural, phyco thearepy all procedures no help with my chronic pain. I have tried so many medications my pain management specialist had told me about with none of them touching my pain level. It took me eleven painful years to get onto a regiment of opiate medication that finally brought back some of my quality of life. I was told by my pain specialist that I would have to taper off my opiate medication that it was against the law for him to prescribe them anymore. He has taken me down from 120 morphine equivalent to 50mg without any care of how drastic my pain is. I was told he could not put me on anything else that this was the law. Is our government trying to purge the chronically I'll patients. How can our government make a decision about my healthcare without even knowing my medical history, and how can they tell me I as an American citizen have no right in the say of my healthcare. I have eighteen years of documentation on what medications work for me what tests have been performed and all the outcomes. The FDA and CDC should look at what you have done to the chronic pain patients in our country. The opiate medication works for the chronically intractable pain patients we are proof all the documentation you need Askari of us to submit our medical records to you to see, perhaps then you could make sure you stop this insane war on us. Because of the CDC and the FDA which are suppose to be helping us I know have no quality of life I have gone back to before I started these medications back to chronic deep agonizing pain that makes you want to give up. Tell us what can we do so you will help us have access to our opiate medication that works for us. Cause if you need us to sign something we will. Please help us today
          • Public Submission
             
          • Posted:
             
            09/04/2018
             
          • ID:
             FDA-2018-P-1846-0061
          Comment from Anonymous
          • I am another victim of ssri/snri drugs (venlafaxine in my case). It's been almost 2 years since I tappered off and I'm still suffering from symptoms like erectile dysfunctions, pleasureless orgasms, non-existent libido, lack of arousal and genital numbness! Moreover, I've experienced and I'm still experiencing another symptoms like emotions flattening, anhedonia and anxiety, I cannot cry even if I want and all things that used to make me happy give me no joy anymore! I never had any kind of sexual problems before that drug! It's a real problem, please help us!
          • Public Submission
             
          • Posted:
             
            10/25/2018
             
          • ID:
             FDA-2018-P-1846-0081



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