Our New Year’s resolution is to strengthen and expand RxISK.org. We want the website to reach more people who have problems or questions about their prescription drugs, and to offer them more resources. Even more important, we want to expand its role as a hub for you to share information about you experiences, hopefully in a way that might serve as a springboard for action.
As a first step, we are bringing back the “RxISK Zones” that were featured on the site from 2013-2016.
What are RxISK Zones?
The Zones are areas dedicated to specific problems which have led large numbers of people to contact us. There are seven Zones so far:
We hope to add a new Zone soon for Fertility Problems (stay tuned).
Each Zone has links to past blog posts, videos, and media articles that shed light on the problem. There are also summaries of what is known about the problem and various treatment strategies, and peer-reviewed academic papers based on RxISK data.
Side effect searches made easy
Each Zone also includes a search engine that automatically brings up a list of FDA-recognized side effect terms associated with that condition. Example: For Sex and Relationships, you will find reports of Sexual Dysfunction, Erectile Dysfunction, Libido Lowered, Female Orgasmic Disorder, Genital Anaesthesia, Marital Problem, and dozens of other terms.
This streamlines the general Drug Search and Side Effect Search functions on our main page, and makes them easier to use. Many of us want to find out if our own symptoms have been reported by others, but may not know the official term they are listed under. For example, is that painful burning or pins-and-needles sensation “tingling,” “paraesthesia” or “peripheral neuropathy”? Are you feeling a lack of sex drive, or desire, or libido? The Zones solve this problem, displaying the most relevant terms for you.
Let us know what you think!
Take the Zones for a “test drive” and give us some feedback. What worked for you, and what didn’t? Are there other features you would like to see in these Zones. Creating Zones ain’t easy but are there additional Zones we should create?
All comments are welcome! They don’t have to be limited to the Zones – if you have other ideas for new features or content to strengthen RxISK.org, we would love to hear them.
But as some guy back in early 1961 almost said:
Ask not what RxISK can do for You but what You can do for RxISK
RxISK is not about the information we feed you, its about what tools we can collectively bring to bear on drug induced problems. Doctors once used to help us with this. Now they are part of the problem rather than the answer. See It’s Health’s Illusions I Recall, I Really don’t Know Health At All.
Imagine
The Fertility Zone To Be might give you some insight on the problems we have and answer that you spot. Hair and Skin and Suicide Zones are relatively easy to create. There are only so many terms for the effects of drugs on these variables. They can be listed and you can get to see where a drug, perhaps your drug fits in the mix.
Violence, Sex and Withdrawal are more complex.
Fertility is a lot more complex again. Violence and Sex and Dependence have a set of terms although within withdrawal there are withdrawal terms along with dependence and addiction terms. With Fertility, all sorts of things can feed into it from hormones to sexual function to pregnancy stability issues and these are more difficult to cleanly separate out.
RxISK can only list 100 drug induced problems without causing the Zone to crash. We have had a few people working on the best Fertility 100 but you might well need something we haven’t listed. It must be something a drug can cause rather than something that leads to fertility problems that has nothing to do with drugs.
Interestingly, classifications of drug induced problems don’t at the moment list anything under Fertility in the way they list Hair items or Suicide and its precursor states. Hair, Skin, and Suicide items can all be found in one classification place but Fertility is dispersed in many different domains.
We are breaking new ground here and need your feedback and suggestions to make it work. The Fertility Zone will hopefully be up in about 2 weeks.
Imagine 2
These were some of the images we had with the original zones. Nothing exciting.
The image at the top of this post is a Japanese symbol for Fertility or Wealth – which in a sense neatly conveys the idea that children are our wealth. We need a set of images for all Zones that are simple, that tell you this is RxISK and don’t put people off, the way the suicide and violence images below put some people off.
Skin
Sex
Hair
Violence
Suicide
Japanese for Despair – would this be a better image?
Cal says
Do you think I would be successful at suing my prescribing doctor for not properly warning me about PSSD? I was prescribed it after the Health Canada warnings that told practitioners to “inform their patients of the possibility” but I wasn’t. I’ve search the web several times to find cases of people launching lawsuits at either drug companies or doctors for causing enduring sexual dysfunction from SSRI’s but there is absolutely nothing. Has no one tried or have they all just been tossed away for lack of evidence?
Dr. David Healy says
A lot of people have looked at the lawsuit option. To sue companies requires a large number of people to make it worthwhile for the law firm. Suing doctors might be an option. There will be posts next week about Antidepressants and Fertility that might make your case even stronger – your doctor has made you effectively infertile rather than just given you PSSD
Something worth checking is whether PSSD is mentioned in patient information leaflets. It got put in the label but that was likely in the small print part of the label for doctors. As the posts next week will illustrate regulators and companies are good at burying things in labels in a way that will mean that the person put on the pills is not informed of the hazard.
In terms of a legal action its going to take people like you to approach lawyers and see if you find one who see a way to take a successful action. If you can you need to feed that back to everyone else. In Canada there are law firms like Tony Merchant in Saskatchewan who are always on the look for actions against companies.
DH
Juan says
Cognitive zones? memory/personality changes? I personally have trouble remembering, eg, I have few memories of the lasts years and the ones I have are very vague, devoid of emotions
Johanna says
I find the measures listed here to restore some of the information previously available on RxISK — and make it even more useful — really exciting. That includes the Zones, and the broader ability for ordinary citizens to access the FDA side effect data.
As for the slogan of “Ask not what RxISK can do for you; ask what you can do for RxISK”? I really do not think there is any contradiction between the two! Access to basic information is the first step to action.
This has nothing to do with folks assuming the role of passive consumers who simply clamor for more info to be “fed to them by RxISK” without making a contribution of their own. Everyone is welcome to use the resources here; there is no point in making anyone feel like they are “a taker, not a giver..” This is especially important for first-time users (whose numbers I hope will grow)! Stumbling across RxISK.org may be their first opportunity to learn about issues which have plagued them for years.
One of the great things about the “Zones” and other resources is that you can make a contribution simply by searching the data and reading others’ reports. You can uncover connections that none of us were aware of. I hope we can soon re-instate access to the comments of other users who have filed RxISK reports. They’re a fantastic source of insight, and a good reason for someone to file a RxISK Report even if they do not have a doctor who is willing to read it.
A good example of what can be discovered is this blog post from 2013, about Topamax and the mysterious “Alice in Wonderland Syndrome”: https://rxisk.org/go-ask-alice/
tim says
RxISK Zones greatly valued. Thank you.
annie says
Quite rightly RoAccutane, is included in Suicide Zone; I was wondering if there perhaps could be more made of RoAccutane under Skin and Nail Zone, as the Skin Zone might be the first place I would look if I was to look up RoAccutane or any other Skin products.
I say this as the article below puts RoAccutane in the news again.
https://rxisk.org/suicide-zone/
RoAccutane and the Perfect Circle
This post by Heather and David Roberts is about their son Olly and the struggles he and they had with the health system, acne and its treatments.
https://rxisk.org/skin-nails-zone/
Skin side effects may not be seen as medically serious or life threatening and therefore less likely to be reported, but their effects can be devastating to an individual. “Your skin is the face you present to the world,” says Dr. Mangin. “So if there’s a link to one of the drugs you’re on, that’s important information for you to have and to share with others.”
Why do top skin doctors want to overturn strict new safety rules on the powerful acne drug that’s been blamed for teen suicides?
Two specialists have to sign a prescription before isotretinoin can be given to anyone under 18
Dermatologists want regulators to row back on the tough new guidance
But parents of youngsters who have died while taking the drug say it is ‘dangerous’
Top skin doctors are urging drug chiefs to rethink strict new rules which hinder them handing out a powerful acne drug to patients who need it.
Safety measures introduced in October for isotretinoin, which is sold under the name Roaccutane, require two skin specialists to sign a prescription before it can be given to anyone under 18 – the only drug to be subject to such a stringent requirement.
The change came after it emerged the drug’s debilitating side effects may have led to the suicides of several young people.
Clinicians have also been ordered to warn patients about isotretinoin’s potential to trigger serious mental health problems such as psychosis, as well as sexual dysfunction.
But dermatologists are pressing regulators to row back on the ‘problematic’ guidance, the Mail has learned.
Many doctors are ‘very unhappy’ about the requirement for a double signature to confirm there is no other appropriate effective treatment. Sources claim it risks patient safety by hampering their ability to offer vital treatment, adding that the drug has been unfairly demonised.
The British Association of Dermatologists (BAD) confirmed last night it was in talks with safety watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA), over ‘parts of the new regulations that may have a negative impact on patients’.
One senior consultant, who asked to remain anonymous, adds: ‘There have been unfair attacks on a drug that’s been around for decades and is a game-changer for people with severe acne. Any restriction has a chance of causing patients harm. Acne can cause people psychological damage, sometimes to the point where they can’t even leave the house.
‘The vast majority of people have a great response to isotretinoin, but sadly they are the people you don’t hear from.’
However, some campaigners pushing for the drug to be banned and argue the current regulations don’t go far enough, with one devastated father of a young patient who took his own life saying it was ‘utterly incredulous’ that doctors might be seeking to relax the rules.
Jonathan Medland, 67, from Barnstaple, lost his son Jon to suicide in 2004 shortly after he stopped taking isotretinoin.
He is certain the drug contributed to the 22-year-old medical student’s death and says his son had never shown signs of depression before the treatment.
‘We were a loving, happy family,’ he says. ‘Our life as we knew it ended the moment Jon died.’
Mr Medland accuses doctors of dishing the drug out ‘like Smarties because it’s an easy fix’.
Isotretinoin was first licensed in 1983 and is regarded as the gold-standard treatment for severe acne that failed to respond to other medicines. Currently taken by 48,000 people in the UK, it works by preventing the skin from producing oils that acne-causing bacteria feed on.
Studies suggest patients’ skin clears up after just four months and the majority are virtually ‘cured’.
However, the drug can be prescribed only by dermatologists due to its potential side effects. The most common include dry skin, rashes, headaches and back pain.
Patients must also be monitored with regular blood tests, because in rare cases it can damage the liver, and women are advised not to conceive while on the drug due to possible birth defects.
In 2019, the MHRA announced a safety review on isotretinoin following a rise in reports of adverse reactions to its Yellow Card scheme, which allows healthcare professionals as well as the public to flag up adverse effects of medicines via its website.
Since isotretinoin was approved it has triggered more than 8,000 such reports, ranging from vision problems and anaemia to joint and muscle pain and even seizures.
However, one in four complaints are for anxiety, depression, behavioural disturbances and thoughts of suicide and self-harm. There have also been 84 cases where patients have taken their own lives, but the MHRA points out the reports are not proof the drug caused these problems.
It also said such stories from patients and their families were enough of a concern to usher in the new measures, however.
One youngster whose tragic death has been linked to the drug was 18-year-old Melissa Martin-Hughes, who was found hanged in 2010 after she spiralled into depression because of severe acne. She had been prescribed isotretinoin and the contraceptive pill to help improve her skin.
The medication was also linked to the death of 21-year-old Luke Reeves, too, died of a drug overdose in 2016. An inquest the following year was inconclusive as to whether isotretinoin had affected his mental state – but acknowledged he was not in his right mind when he died.
Roche, the drug giant who developed isotretinoin, says: ‘Millions worldwide have taken Roaccutane but, like most medications, it can have side-effects.
‘It is vital that patients are fully informed as to what to expect when they take it and that they are monitored closely to ensure they get the ongoing care they need.’
Dermatologists also point to the findings of a major review published in November as reassurance that the drug is safe.
The study looked at data from 1.6 million patients to see whether there is a link between isotretinoin and serious mental health problems. It found the risk of suicide two to four years after stopping treatment was actually lower in patients on the drug than those not prescribed it.
Dr Tony Bewley, a consultant dermatologist at Whipps Cross and Barts, explains that the risks of isotretinoin, like any drug, must be weighed up against the benefits – most importantly the well-accepted fact that severe acne itself can have a significant impact on mental health.
He says: ‘Acne is mild in many patients and will be dealt with by a course of antibiotic cream the GP can prescribe, but in severe cases it’s an inflammatory condition that causes boils and cysts on the chest and back that make sitting painful. Many patients complain of burning and itching skin.
‘There is also a great deal of stigma – people worry they’ll be judged for being dirty, unkempt or just not looking after themselves. They’re told it’s because they’ve eaten too much chocolate or fried food, which isn’t the case.
‘Often, they’ll keep their feeling of depression a secret because they worry that they’ll be seen as vain for worrying about a problem that others see as trivial.
‘The longer it goes on, the worse the risk of scarring – which is life-long – and the worse the mental health impact.
Dermatologists treat the severe cases that don’t respond to standard drugs and when all else has failed, isotretinoin is an option.’
But Helen Wright, 52, insists her daughter, Annabel – who took her own life aged just 15 in 2019, six months after starting a course of isotretinoin – was not depressed before she started on the drug.
Mrs Wright, from Ripon, North Yorkshire, says: ‘My daughter’s acne was mild. I questioned the dermatologist at the time because I’d heard stories about people in America.
‘She told me people took their own lives because they were depressed about their skin, not because of the drug. She said she wanted to put Annabel on it before she got any scarring and assured me it was safe. I believed her.’
She recalls that before her daughter died, she had been excited about a friend joining her on the family’s holiday to Spain and revising for upcoming exams.
Mrs Wright says she believes ‘whatever hit Annabel, hit her like a tidal wave’, adding: ‘We had no idea what had happened.’
It was soon after Annabel’s funeral that Mrs Wright and her husband, Simon, 59, discovered other young people had taken their own lives in similar circumstances.
‘A friend showed me a news article about how medical student Jon Medland had died and everything suddenly made sense.
‘Annabel wasn’t depressed, she had no problems and had been bright as a button on the night she died. She had a perfectly normal conversation with her father, then went upstairs. We later found she had messaged a friend saying “I feel down” – and that was it.’
At an inquest in 2021, the court heard that in the months before her death, Annabel had posted a photo on Snapchat captioned ‘life is not worth living’ and had self-harmed ‘but could not explain why’, according to her mother.
A coroner determined there was no evidence that isotretinoin had caused or contributed to her suicide – a verdict the Wright family has branded ‘wilfully ignorant’.
Mrs Wright says the drug is ‘dangerous’, adding: ‘Dermatologists are unwilling to give it up as isotreninoin does work. But the side effects are so bad.’
She has also accused the doctors of ‘not listening to what patients are saying’, claiming ‘that’s why what this drug is doing isn’t being properly documented’.
The main concern about the new guidance among specialists is a practical one, claim those the Mail has spoken to. ‘Some dermatologists, especially in private practice, don’t have another doctor working close by to ask to review the case in order to get the second signature,’ one source says.
‘In these cases, the patient would be sent back to the GP who referred them, as they’re permitted to sign off on the prescription – but this could take weeks.
‘The decision to change the guidance wasn’t based on any real evidence – the drug has been linked to suicide but science doesn’t support the claim. If anything, it reduces the risk.’
Not all experts are against the new checks, though. Dr Alia Ahmed, consultant dermatologist at the London Skin and Hair Clinic, says: ‘Alongside the reports from patients suffering low mood, there is evidence that isotretinoin can affect brain function. Until we understand this better, it’s difficult to say dermatologists should ignore the MHRA.
‘It can be disappointing for patients who turn up expecting a prescription. But I explain it’s for their own safety.’
But the British Association of Dermatologists says: ‘Some aspects of the regulation are new and some of these will likely prove to be very challenging to implement.
‘We are aware that parts may call into question the viability of some acne services and have a negative impact on patients. One important issue raised by acne services repeatedly is the requirement for two prescribers to approve the treatment for patients under the age of 18.
‘BAD is collecting feedback from our members to understand the most pressing issues and feed these back to the MHRA, and it is hopeful that particularly problematic areas can be resolved.’
Vic says
Yes!! Citalopram gave me PSSD told doctor in 2005, she told me it was depression and laughed at me and said “you need sex to get pregnant” nothing happened for 4 years (after we easily fell pregnant with daughter in 2001 before medication) turns out I had Akathisia from an anti nausea med in pregnancy… Misdiagnosed as depression, Prozac massive adverse reaction, then because still insomnia put on citalopram which made everything worse. Memory got worse and worse until misdiagnosed ADHD…. Took myself of citalopram, sex drive back and after 15 years of PSSD and “infertility” fell pregnant… Twice!! Was told impossible. Lost business so struggling to afford things but feel so lucky. 15 years of hell, medication induced infertility, depression, insomnia, misdiagnosed ADHD, and severe Akathisia when pregnant, now off meds for over 3 years and loving life… When I mentioned at smear test they said SSRIs affect pituatry gland and can cause infertility, they weren’t supprised at all… Also polycystic ovaries, fibroid on citalopram… Disappeared now off meds!
John says
You should make a forum with freedom of speech regarding protocols and theories. Propeciahelp forum banned all discussion regarding it.
Dr. David Healy says
We take anything that’s vaguely sensible that comes along. There can be stuff that is just plain not sensible. We also have the RxISK Prize for anyone who has a good idea that comes with evidence.
If people really think they have the answer they can be $100 K – ‘good’ ideas are cheap and often just the product of a bored mind. PSSD and related problems are too serious – they need more than a talking shop. There are all sorts of other avenues for that.
There are two other points besides. If we get to the point of taking a legal action, idle chat on a site like this could sabotage any hope of succeeding. Second, if we get researchers interested to do solid work they are going to look at this site to get a sense of how serious we are. Too much trivia will lead them to head elsewhere.
D