Here because of Isotretinoin? You must read this topic

General Discussion
#1

Hello everyone.

I have some potentially quite good news to share. This will be of specific interest to PAS sufferers, but it’s also no doubt relevant to the wider cause.

The MHRA, the drug regulating body in the UK, have announced that they are going to convene an Expert Working Group (EWG) on Isotretinoin, with submissions from the public regarding this matter open until 2nd Feb 2021.

EWGs are convened to consider specific safety concerns relating to a drug. This particular EWG will be evaluating three main areas of concern in relation to Isotretinoin:

  1. Psychiatric adverse effects (particularly depression and sucidiality)
  2. Sexual dysfunction in both men and women
  3. Long-term impact on fertility

The purpose of the EWG is to conduct a comprehensive scientific evaluation of all the available evidence relating to these three areas, before advising on any further research that might be deemed necessary.

The group will be made up of independent experts selected because their expertise specifically covers the relevant areas, as well as members of a group called the Commission on Human Medicines (CHM), which is a subcommittee of the MHRA.

It is also stated that “views of stakeholders are considered”, which, de-jargonised, I think means there will be pharmaceutical industry representatives present.

But crucially, the group will also include lay people i.e. non-experts. This opens up a space for PAS sufferers themselves to attend and give testimony.

So this is a call to all PAS sufferers/Accutane victims living in the UK. This is an opportunity for your story to be heard by people who might actually have the power to make a difference.

This is the first time an EWG has focused on the association of Isotretinoin with sexual dysfunction. There was one convened in 2014, but back then it was only to look at the psychiatric effects.

While the MHRA doesn’t conduct or directly commission clinical research itself, based on the findings of the EWG it is capable of imposing a requirement for further research on the drug companies which they must fulfil or risk losing their licence to market the drug.

We must do all we can to ensure this is precisely what happens.

It should go without saying that further research into the association of Isotretinoin with sexual dysfunction has the potential to benefit all of us on this forum.

And if the drug companies failed to fulfil the requirement for further research in a satisfactory way, and the MHRA revoked their licence to market the drug in the UK, not only would many young people be saved from the Hell we have had to endure, but it would also send out a huge statement about the safety of this drug to the international medical and scientific communities, raising the profile of PAS significantly. This, in turn, would be likely to spark off further research by independent researchers.

It’s not yet clear what the selection criteria will be, if any, for who will be allowed to participate in the EWG as a lay person, nor has a date yet been set for when the group will take place - though it seems likely we will hear more within the next few weeks.

But if you are are a PAS sufferer based in the UK and you’re brave enough to consider speaking about your condition before a committee and contributing to what could potentially be a big win for all PAS sufferers, please let me know, and I can keep you informed of further developments.

It’s easy to be cynical about the limits to the power regulators actually have, and much of that cynicim is for good reason, in my opinion. However, this is an opportunity to exert some pressure and really test those limits. We musn’t let this one pass us by.

Thanks,

Albert

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#2

Isso é um grande avanço, atualize o post irmão sobre como está indo as coisas em relação a isso, obrigado

#3

Everyone who has sexual sides or even better EVERYONE on this forum should do this survey. It is only a few questions. The government ignores the sexual side effects in part because Not Enough People Report. They are (sorta) listening RIGHT NOW. We only have until end of Jan.
Yes, it is not enough…but it is a start. Our words may literally save a life…when else can save someone’s life with just your story? Please tell it!
https://www.surveys.mhra.gov.uk/5fa2caf33414eb1dd21958ad

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#4

This is a good chance to make a difference. I’m tagging @Dubya_B on this because I assume he’ll know where to check that it’s been shared.

@AnnaNim, thanks for bumping this, it needed it. Please consider taking our symptom survey.

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#5

It IS super time sensitive! It is so important! This inquiry is only collecting information until start of Feb…we won’t have another shot for years & years to tell our story. (I will have my son fill out the survey here, I was kinda waiting to see if/how much he’d recover. Sadly, I am still here). Such a nightmare. All I think about. My only son is so damaged for NOTHING but profits.

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#6

Thanks for bumping this, @AnnaNim.

I will reiterate what I said before: whatever your thoughts on the regulators, if you don’t contribute to this you have no right to complain afterwards if it leads nowhere. It’s only going to take a couple of hours of your time (or even less depending on how much you want to say).

This is the first process of its kind to consider sexual side effects and if we, the sufferers, can make an impactful response, this can only contribute in favour of the outcome we want, whether it comes now or further down the line.

Also, I will say it’s cathartic to air your grievances to people on a high level of the medical establishment. So even if you just want to use it to say a nice, big ‘fuck you’, I promise you, it’ll feel good.

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#7

A Big Fk you, indeed! Tell em the gritty, uncomfortable details! They WANT to hear from us. They NEED to hear about the sexual sides! My son is making a video this weekend (I am out of town)…then he is not just a line of text. You do not have to have taken it, all the Finn and Propecia people can chime in too. Better than voting :slight_smile:

1 Like
#8

@Luckydevil, I’ve renamed this topic, since the response has been disappointing.

I’ve also shared this through the PH twitter account.

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#9

Let’s do this! We’ve a large group of Iso/Accutane men & women who’s sexual functioning has been damaged by this drug. We are already gathered, so now tell the MHRA (like the FDA, but the UK) what is REALLY going on with this drug! Just 5 questions. We can go back to trying to fix ourselves & all that after helping warn the world what is going on. This is the chance we have been waiting for!! Here is the link: https://www.surveys.mhra.gov.uk/5fa2caf33414eb1dd21958ad

Here is what I sent them below last year before the inquiry was paused due to COVID. I will post my son’s letter after he has written it. We were waiting after seeing the specialist…who of course told my son last week that he did not have ED, or shrinkage, and refused to do ANY blood work or tests and just tossed some Viagra at him. He was LIVID. A 19 year old knows how when his penis is broken FFS. I know they can’t do anything, but I wanted a diagnosis to share with the MHRA…
Colette

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#10

Here is my 2nd letter I sent earlier this year, before they changed the questionaire (to 5 shorter questions). Feel free to use and share this info.
MHRA Members,

To add onto my previous letter:

While suicides are a horrific “side effect” and clearly is the worst individual issue that a person can have on Accutane, the overall deadly serious issue with Accutane is the widespread and ignored permanent issues with this drug that can occur even after completing a course. This drug causes widespread, brain and body damage, with no cure, and NO real acknowledgement of the problem. This so-called drug causes cascading issues and countless parents and damaged people are online begging for help and none is coming. I feel everyone who takes it is affected, it is just a question of how bad. We are playing Russian Roulette with our children. After what I know now, I am convinced that the continued existence of this drug should be criminalized. Please do not turn this into a “benefits outweigh issues, more patient education is needed”, please look at how shocking dangerous this drug is. My only child, my son is damaged, and he is not even as bad as other people I have met, yet it has ruined our lives. It is actually hard to believe how bad this drug is, in my own horror and fear, I myself had some denial when my son first started having issues, and that denial and disbelief by the public and doctors is part of what keeps this drug on the market. I wait everyday for the other shoe to drop. It is a nightmare that never ends.

You may not know this, so here are some of the Common and Permanent side effects caused (but ignored by the medical community) issues of this drug:

-progressively deteriorating joints and destruction of synovial membrane/fluid (possible joint pain/arthralgia and DISH is mentioned with high doses/long term, but this is never mentioned that this could occur AFTER discontinuation with no prior joint pain/warning while on the drug. ‘Joint pain’ in the insert is never classified as permanent synovial damage, but rather vaguely associated with a mostly temporary inflammatory reaction or possible DISH, which isn’t anywhere as serious as synovial damage. The label is incredibly misleading as well as physicians’ understanding of this issue.)

  • permanent muscle damage (that occurs w/out warning such as weakness/pain after the drug is stopped - not just rhabdomyolysis, a rare condition that can be caused by many different drugs, as is mentioned in the insert!

  • progressive degenerating/desiccated discs (not listed at all in insert. many are perfectly fine on the drug, then months/years after develop early degeneration…and yes, it is from the drug)

  • bodywide tendon/ligament/bone/muscle pain and damage (mentioned as ‘rare’ side effect in the insert, but NOT mentioned that this can occur after discontinuation and progressively worsen with time.)

-permanent sexual dysfunction (Men and Women…absolutely a cause of suicides. Imagine being 17 and your penis does not work. My son is having some ED issues that have persisted after the drug is over)

  • IBS/Crohn’s (mentioned it could occur while on the drug and persist, but never mentioned it could occur months or years after exposure. This controversial effect is refuted by all but one major dermatology studies, and most derms don’t even believe there’s a link at all! The studies on IBS/Crohn’s/IBD stating ‘no connection to accutane’ are totally fraudulent!)

-permanent serious BRAIN DAMAGE (Not listed in insert! Depression, yes, brain damage no. Also can occur while on or after discontinuation Brain fog, exhaustion, short attention span…and this is where the suicides are from.

-permanent meibomian gland dysfunction that starts AFTER stopping the drug with 0 symptoms while on it (happens to A LOT of people, also not listed insert and denied by most doctors despite existing research. Most dermatologists and even some ophthalmologists completely deny this as being a possible permanent issue, even though it comes on later)

  • visual disturbances - permanent night blindness is mentioned in insert, but development of floaters and progressive eyesight deterioration after discontinuation is not. Also, permanent visual issues are largely underestimated and listed as ‘rare’ when in fact they are fairly common! (My son is having extreme light sensitivity and it didn’t start until 3 months off of it)

  • organ damage - your organs can be permanently damaged either on or months after stopping the drug, with or without abnormal lab results. Insert mentions that permanent organ damage is possible while on the drug and that ‘it may not return to normal after’. Many of us thought we were being appropriately monitored only to find organ damage occurring months/years after discontinuation.

  • permanent skin damage - the insert/physicians emphasize that cutaneous side effects are temporary and return back to normal within 6 months. Many others, find that skin becomes permanently fragile, thin, aged, dry, and overall damaged. For some, this damage occurs AFTER stopping the drug. No warning about that! Most doctors I’ve spoken to say it’s ‘antiaging’ and deny that the majority of people get permanent dryness afterwards.

  • alopecia - mentioned in the insert, but NEVER mentioned that permanent hair loss can happen AFTER stopping the drug, with/without hair shedding on the drug. VERY underestimated - most docs will say they’ve “never heard of this and it’s extremely rare, only happens at higher doses”. Not true. (My son is having hair loss, months later)

  • neuropathy / paralysis - another severe damaging effect that can occur after stopping, is also never mentioned in the insert

  • permanent feeling of illness, chronic fatigue, malaise, and generall severe sense of poisoning/unwellness: so many accutane users report this post-accutane and it gets worse with time, not better. Something is WRONG with them and they know it. My son has been “sick” so much since getting off this drug. He is ALWAYS, ALWAYS ‘tired’. He eats well, take supplements, and was 100% healthy before this drug…

-and many many others…

The true risks of Accutane are not being told. Many people know that accutane has been linked to possible suicide risk to patients who are taking it. But T hat’s not the scary part. most of us were CERTAINLY not informed about everything listed above. Many people kill themselves months or years after stopping because of the issues above-they destroy your life and often at young age.

Everyone knows that drugs have side effects and we all take calculated risks in our daily lives. We know a car ride could end in quadriplegia or death. We know we could have infections from surgeries.

Most risks are self-evident or legally disclosed by providers/packet information.

We took accutane knowing that it had some risks. However, I gave my son Accutane not knowing the real truth-which has been covered up in terms of so called “incidence of risk” for serious side effects (FYI: they are much, much higher than stated! Not 1/10,00…) and the potential for post-exposure damage, which has been happening for nearly four DECADES and actively being denied/covered up with fake/fraudulent research, incomplete package information, and a dishonest medical system.

When will the drug labels change to reflect these risks? When will doctors stop lying to patients, ignoring, dismissing and denying the reality of Accutane post-exposure illnesses/damage?

This drug causes irreversible, unpredictable, unavoidable, not purely dose-dependent (happens at low dose), and not-so-uncommon damage.

This drug should be banned, research should be done in how to help sufferers with the brain and body damage.

I know that so-called Big Pharma can’t be beat, but people, including my son, are being damaged by this “drug”.

Get it off the market.
If you will not do this, at the very least then make it only above age 18 (thus ensuring only the worst cases get on it), only after a year of intense monitoring by a Dermatologist that includes dietary changes, require a very low dose/short time frame and INTENSE education by both doctors and patients about the true risks…of which, after someone has been educated, they would never agree to take such a risk with their very health.

Sincerely,

Colette Ann

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#11

Here is my first letter I sent (I am going to ALSO write and answer the 5 questions on the survey. Join me! This is our chance!

Subject: Roacccutane Inquiry

MHRA,

I am writing in regards to the upcoming inquiry regarding Roaccutane/Accutane/Isotretinoin as a concerned parent. I firmly believe this is the most dangerous drug on the market today. No amount of blood work, monitoring, or expanded PIP’s will make this drug safe enough for the bodies and brains of our young people. My son has been damaged permanently by this drug and it should be taken off the market.

Side effects of this drug are grossly underreported. Because of this, the public believes it is not as dangerous as it is. The term “side effects” does not do justice to the horrors this drug causes. Permanent brain fog, permanent sexual issues, permanent vision issues, permanent depression and permanent joint pain, triggering of autoimmune diseases and cascading health issues from the gut/brain malabsorption are caused by this brain-damaging chemotherapy-type drug. If the public knew that the risk of PERMANENT damage was as high as it is, then few would take it. In fact, sheer disbelief and denial over how bad this drug is is what leads to its continued presence on the market. Surley, the government would not allow a drug that is this bad on the market for 40 years, right? Knowing what I know now, it is unbelievable that this is still on the market.

My beautiful, only son, my only child took Roaccutane for about 6 months two years ago and seemed to do okay with normal side effects (dry skin, bloody nose, etc). I now realize that it stunted his growth. He is no taller than myself or his father, despite having very tall brothers and uncles on both sides of the family. He also has had and some other issues that I now realize is likely from the drug, although I did not realize it at the time. My Doctor had told us that there was a “very small risk” of growth stunting, depression, dry skin and not to get pregnant. Any paperwork would have been dismissed as, “All drugs have side effects.” How wrong I was.

The real trouble started when his acne returned. I thought that a short second course would be appropriate, especially since his first round was “successful”. In July 2019, he started taking 80 mg a day. Two and a half months into his course, he came to me and told me that he noticed something wrong with his penis. He stopped taking it THAT day. Now, almost four months later he still has raised testicles (unsure if they are shrunken or simply higher), Peyronie’s Disease (curvature), his penis has rotated on axis, and has a possible decrease in size of penis. He previously reported excessive post-orgasim exhaustion, issues with rebound rate, sensitivity and libido as well.

As his mother, I should not know this much about his sexual functioning. Imagine how scared he had to be to come to his mother about this! I am still awaiting the results of complete blood work checking his hormone levels. Although, I have discovered due to this drug damaging your pituitary gland, that even if he is lucky enough to have ‘normal’ blood work, the hormones may not be uptaked into the brain. I have personally spoke to almost a dozen other men with permanent sexual issues from this drug, some of them decades afterwards. I have also spoken to people with other issues decades later.

People find it hard to believe my son has so many issues from a legal drug. It seems impossible, until you realize how common this is. There are Facebook groups of thousands of members suffering from side effects. It is an open secret. My son has ongoing joint pain, changes to the texture of his hair (as I now know this is a chemotherapy type drug), sleeping issues, ongoing low energy, and stomach issues. He lost weight; a lot of it. He is 1.55 meters and only 60 kg, despite my attempts to fatten him up. His stomach is bothered by almost everything he eats. My son is worried his hair is thinning, and I think he is right. Worse, he has developed light sensitivity, decreased vision issues and appears to have some sort of blind spot at night in the center of his vision. A trip to a regular opthamologist shows no issues, we will be seeing a neurologist opthamologist when I can get him in, but I have little hope doctors can do anything. They do not seem to do anything after this drug damages the body and are in denial. The dermatologist wipes their hand of you, the specialists are in denial and the patient is doomed.

My son also became very, very depressed on this drug. He and I talked about it, his doctor talked about it. I watched as he became negative, irritable and depressed-but yet, the Doctor continued to prescribe it. It was not until he had been off the medication for a few weeks that he realized just how depressed he was. We thought we were aware of the effects of this drug, we were paying attention and looking for signs, yet my son was floored at how much better he felt off of it. That is terrifying. No one realized how bad it was.

In regards to the suicide risk; suicides are not due to the oft-quoted “predisposition to depression” mindset. If so, you would think simply getting off the drug when your depression gets too much, and monitoring by concerned, loving parents and mindful doctors would stop it. But it is not the case, this drug literally changes the very way a person thinks. It induces psychosis and irrational thinking without warning.

Do not underestimate the silent epidemic of young men suffering from permanent erectile dysfunction, testicular pain, genital numbness, lack of bility to orgasim, and libido as part of the, “Isotretinoin Suicides”. The effect of a young man losing their sexual functioning absolutely causes suicide. Due to the type of nerve or brain damage to the sexual organs/part of brain, doctors are little help. Many suicides from sexual or other permanent issues caused by this dangerous drug, but they occur months and years later out of sheer desperation.

Money makes the world go around, but at the cost of our young people’s bodies and minds. This drug is far more dangerous than realized. While not everyone suffers permanent side effects, I feel that no one escapes unscathed. The damage is cumulative. No amount of regulation will make this safe. None It is like asking, “How much rat poison is safe?” The answer is none.

Please take action to save other children.

Respectfully,

Colette Ann

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#12

@PAS, @vkg1, @Dubya_B

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#13

I’m working toward spreading the word on FB. Will try a few other less-active post-Accutane communities also.

1 Like
#14

It is hard work too. For example, 270 views of right now have seen this post. Imagine the impact 270 people would have! But, I suspect only a few have written in so far. I know Sam has been fighting for YEARS and had many, many conversations with them. If we don’t respond to it, it looks like she and other families who’s children are damaged died are the rarity, not common. :frowning:

Maybe this post can be pinned for a few months.

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#15
#16

Done

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#17

@michi100702 @09eric09 @Tbone1234 @ivantheterrible @Braemar @Emglo123 @MikeF @gunnersup @Ronnie99

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#18

@SCW @Chris1011 @Catto @Samjam @healed_from_tane @Simboni @Mat12345 @Jire @Lmc67 @David

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#19

@KTdr @Pab @flynn @Starseed @Kkaempf @Shilpa @Waytocure @squeem @LP1 @rohangaur

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#20

@AnnaNim @CorryTavella @iso1 @baraart @rvth1 @Jackidk @fml1 @crest @karthickeyan @Roddy

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