Statin tablets.

[classic33]

The Yellow Card system is there, for the person on the medication, for reporting any side effect(s) not listed. If enough people report the same issue(s), then changes may be made. At the least, it will get the side effect(s) noted.

As for cost, a 3,600% price increase was acceptable when Pfizer sold their licence for Phenytoin to Flynn Pharma.

 

[mjr]

The Yellow Card system is there, for the person on the medication, for reporting any side effect(s) not listed. If enough people report the same issue(s), then changes may be made. At the least, it will get the side effect(s) noted.

The side effects of statins are mostly noted but I suspect underestimated. I also suspect Bill might agree with that, even without the more dramatic claims.

 

[roubaixtuesday]

the MHRA Yellow Card system which I've never known produce a change.

List of safety issues identified through the Yellow Card system

https://assets.publishing.service.g...Yellow_Cards_to_identifying_safety_issues.pdf

 

[classic33]

The side effects of statins are mostly noted but I suspect underestimated. I also suspect Bill might agree with that, even without the more dramatic claims.

And if more people reported side effects when taking them, or any medication, then the list of side effects would be more accurate.

Anything introduced into the body will have side effects. However not many people seem to be aware of possible side effects, and watch for any when being started on them.

 

[mjr]

List of safety issues identified through the Yellow Card system

https://assets.publishing.service.g...Yellow_Cards_to_identifying_safety_issues.pdf

Exactly: no drugs I know there.

Just 25 drugs affected in 8 years, mostly with just advice updates.

 

[vickster]

There are lots of other ways in the UK and other countries for reporting side effects with drugs, branded and generic.

Indeed, market researchers are obliged to report any side effect /adverse event mentioned for clients' drugs mentioned in market research. However well documented, not just 'new' ones. Actually not just side effects, there's a very long list of potential issues that we are required to report including issues with packaging like a missing PIL.

As are MSLs and sales reps and any other pharma company employer who might receive a report of anything to do with their company's drugs/devices/products.

MHRA Yellow card is for UK, other countries have own similar system.

 

[mjr]

There are lots of other ways in the UK and other countries for reporting side effects with drugs, branded and generic.

And for each channel, what % of patient reports are accepted as possible side effects and what % are dissmissed as, for example, unrelated cramp until the patient can no longer stand during episodes and makes a miracle recovery upon a locum stopping the tablets?

 

[vickster]

Muscle issues are a well documented potential side effect with statins so not sure what your point is?
Eg atorvastatin
https://www.drugs.com/sfx/atorvastatin-side-effects.html

All reports are sent to the pharma co pharmacovigilance department so all are accepted assuming the patient was on that company’s product

 

[classic33]

And for each channel, what % of patient reports are accepted as possible side effects and what % are dissmissed as, for example, unrelated cramp until the patient can no longer stand during episodes and makes a miracle recovery upon a locum stopping the tablets?

If the symptoms stop when you stop taking something, do you not say "No" if the same ones are mentioned as a possible at a later date.

Often the changes made may be that small you'll never notice. It's often an increase in the number of people reporting the same problem, which may raise it into the next level(1,000 to 100 for instance).

If no-one mentions problems they have, how are the manufacturers to know. One I mentioned earlier had a slight change of the other ingredients in the medication formulation, when the licence swapped hands. It took 18 months before they admitted there was a change in the overall formulation.

 

[mjr]

Muscle issues are a well documented potential side effect with statins so not sure what your point is?
Eg atorvastatin
https://www.drugs.com/sfx/atorvastatin-side-effects.html

All reports are sent to the pharma co pharmacovigilance department so all are accepted assuming the patient was on that company’s product

The point is that doctors are not passing on all things reported to them, so it's not that "all reports are sent to the pharma co", so there should be some attempt to estimate the loss rate. It would be extremely foolish to act as if this is the first ever reporting system with zero data loss.

ETA: that drugs.com page is very odd. In the "consumers" section, it lists muscle pain under "rare" and joint pain as "not known", whereas lower down in the "healthcare professions" section, muscle pain is "common" and joint pain (arthalgia) is "very common" at about 1 in 9! Is it any wonder sufferers feel that we're being bamboozled about how common these are?

 

[mjr]

If the symptoms stop when you stop taking something, do you not say "No" if the same ones are mentioned as a possible at a later date.

1. I also suffered memory loss, so sometimes I probably didn't know if it was the same ones mentioned again, especially as every statin seems to have at least two names (Atorvastatin/Lipitor, Simvastatin/Zocor, Rosuvastatin/Crestor, Cerivastatin/Lipobay, ...), plus memory loss in general really knocks your confidence in your own judgment, plus some of them can change a person's moods - I don't know if that happened to me (how would I?) but I know it happened to a close relative.
2. As far as I can recall (see point 1), they get you back on the same one again by saying that the muscle problems were more likely just a coincidence, so you should try it again. Then the second time, it's that it's a different dose or ingestion timing or manufacturer or whatever. Then after it fails again, you get persuaded to try a different statin because it's newer/more-tried-and-tested/fat-soluble/water-soluble/whatever, especially if it's referred to by the brand name and not a name ending in "statin". Then it's all good for a few days until you're curled up in a ball with the pain next to your bike at the side of the road again.

If no-one mentions problems they have, how are the manufacturers to know.

How about independent/arms-length testing, publishing all the clinical test data instead of mainly those that run to successful completion and, in the case of statins, of actually having tested the drugs in patients who were also demonstrably making the recommended lifestyle and diet exercise changes rather than an average vulnerable cohort? Or properly following up on studies like the 2004 Sinzinger and O'Grady pilot that found only a small minority of professional athletes could tolerate any statins?

But I did mention the problems I had, plus I've heard of plenty of others with similar problems and yet still our experience is denied and dismissed with comments like "the evidence we have at present overwhelmingly says that from a population perspective statins are a good thing" while I have very little confidence that most problem reports are getting to the manufacturers or regulators in a way that gets counted and totalled up.

 

[classic33]

1. I also suffered memory loss, so sometimes I probably didn't know if it was the same ones mentioned again, especially as every statin seems to have at least two names (Atorvastatin/Lipitor, Simvastatin/Zocor, Rosuvastatin/Crestor, Cerivastatin/Lipobay, ...), plus memory loss in general really knocks your confidence in your own judgment, plus some of them can change a person's moods - I don't know if that happened to me (how would I?) but I know it happened to a close relative.
2. As far as I can recall (see point 1), they get you back on the same one again by saying that the muscle problems were more likely just a coincidence, so you should try it again. Then the second time, it's that it's a different dose or ingestion timing or manufacturer or whatever. Then after it fails again, you get persuaded to try a different statin because it's newer/more-tried-and-tested/fat-soluble/water-soluble/whatever, especially if it's referred to by the brand name and not a name ending in "statin". Then it's all good for a few days until you're curled up in a ball with the pain next to your bike at the side of the road again.


How about independent/arms-length testing, publishing all the clinical test data instead of mainly those that run to successful completion and, in the case of statins, of actually having tested the drugs in patients who were also demonstrably making the recommended lifestyle and diet exercise changes rather than an average vulnerable cohort? Or properly following up on studies like the 2004 Sinzinger and O'Grady pilot that found only a small minority of professional athletes could tolerate any statins?

But I did mention the problems I had, plus I've heard of plenty of others with similar problems and yet still our experience is denied and dismissed with comments like "the evidence we have at present overwhelmingly says that from a population perspective statins are a good thing" while I have very little confidence that most problem reports are getting to the manufacturers or regulators in a way that has any noticeable effect.

Have you contacted the manufacturers directly?

If you've had problems with one, or a combination, did you never check what the known side effects were. This isn't have a go at you, it seems you're not alone on this bit.

 

[mjr]

Have you contacted the manufacturers directly?

I can't remember! (see point 1 above) I filled in a yellow card, once that system started.

If you've had problems with one, or a combination, did you never check what the known side effects were. This isn't have a go at you, it seems you're not alone on this bit.

I did read the leaflet (and I know I did because it was before I started taking it so I still remember that bit!) because I came to it from other drugs that have to be taken two hours after and four hours before any other medication. The branded leaflet for Lipitor used to say to ask your doctor for a full list of side-effects but came with an unbranded additional leaflet (specially for the UK? or the EU?) listing dozens of possible symptoms, mixing trivial stuff like belching and pins-and-needles with the serious stuff like memory loss. Most of the serious ones were labelled as "uncommon" and when I ask something along the lines of "well, if each of these 20 (or whatever) are up to 1% of people, how many people suffer at least one of the serious side effects?" I'm more-or-less-told/persuaded to stop worrying about it, but in many more words. I did actually change doctors at one point early on after one told me with a straight face that atorvastatin had no side-effects.

I don't take offence at you suspecting I didn't read the leaflet. I suspect most doctors don't read the info either, because the current Lipitor leaflet (and I think the British National Formulary is similar) says "The usual starting dose of Lipitor is 10 mg once a day in adults [...]Your doctor will adapt the dose at intervals of 4 weeks or more. [...] " but I know so many people who have been started off on high or maximum doses, which I think increases the severity of any adverse reaction.

While I've got the current Lipitor leaflet open, I counted up that it says there are 16 "up to 1 in 10" side-effect symptoms (contradicting drugs.com as mentioned above), 30 "up to 1 in 100", 12 "up to 1 in 1,000", 3 "up to 1 in 10,000", 1 unknown severity and 4 possible - so somewhere between 1% and 100% of people have side-effects with this shoot, yet it's still overwhelmingly positive? Hmmm.

There is part of me which wonders what I'll do when I (or the hospital) run out of medications to try. I'll probably keep avoiding the statins and accepted the increased risk from using less effective drugs. Better to live a day on my feet than a year on my knees.

 

[vickster]

The point is that doctors are not passing on all things reported to them, so it's not that "all reports are sent to the pharma co", so there should be some attempt to estimate the loss rate. It would be extremely foolish to act as if this is the first ever reporting system with zero data loss.

ETA: that drugs.com page is very odd. In the "consumers" section, it lists muscle pain under "rare" and joint pain as "not known", whereas lower down in the "healthcare professions" section, muscle pain is "common" and joint pain (arthalgia) is "very common" at about 1 in 9! Is it any wonder sufferers feel that we're being bamboozled about how common these are?

If questions talk to pharmacist as well as doctor. If under hospital, ask to talk to hospital pharmacist

All drugs originally have a brand and a scientific compound name (the name that the generics have)

 

[mjr]

Read the PIL in the pack, questions talk to pharmacist and doctor.

Yes, that standard suboptimal approach is exactly what I did and why I can no longer remember months of my life, scattered over years. Excuse me if I don't welcome that advice. Primary care doctors generally don't know what to do about statin side-effects and some won't refer to specialist hospital care when they should. I'd advise people to exhaust other treatments (including diet and exercise) before statins, don't start on a high dose and if they hit problems, don't accept a GP fob-off: if one's doctor of record won't listen, ask to see a different doctor, or go to a walk-in clinic.

All drugs originally have a brand and a scientific compound name (the name that the generics have)

The brands should be outlawed, especially for drugs like statins that are known to bend minds. It's difficult enough keeping track of one's treatment while drug-addled without everything having many names. Yes, there will be at least one brand and compound name, but there are sometimes others: atorvastatin has at least three compound names and 14 brand names, for example.

Also, there used to be fark all support offered for coping with starting perpetual medication but hopefully that's changed with the greater awareness of mental health care.