Medicine side affects not listed in paperwork, how complain?
Medicine side affects not listed in paperwork, how complain?
Author
Discussion

philv

Original Poster:

5,373 posts

243 months

Friday 30th August 2019
quotequote all
Hi,

i was prescribed medicine for acid reflux.
Which i tool for a short while.

I soon started to develope a neurological condition.

I have checked the paperwork on the medicine paperwork in the box.
No mention of any neurological affects or risks.

I have had an mri, and due to see a neurologist for a 2nd time soon.

It seems likely that nothing can be done, and it will be wait and see how the condition developes.

The symptoms certainly suggest a certain condition, which after research on the interest, i have found to be linked to the medicine i took.

I am not particulalrly happy that i now have a condition that makes sleep difficult, may result in difficulty walking or worse.

I am also having problems with insurance as neurological conditions such as these may result in a shortened life.

Have i any recourse to complain, etc?

Who can i contact?

Mastodon2

14,324 posts

194 months

Saturday 31st August 2019
quotequote all
You'll find the manufacturer's contact info on the packaging, or you could try their website.

philv

Original Poster:

5,373 posts

243 months

Saturday 31st August 2019
quotequote all
I contacted one of the no win no fee lawyers.
They reckoned as the doctor could not be expected to know of any side effects (not on nhs website or medicine leaflet) , there was little chance of success.

What is annoying is that the govt has something called the yellow label scheme which is where people can report side effects they have had from drugs.

On there it is possible to see what categories of side effects have been reported for each drug.

The drug i was prescribed has 100s of reports of neurological side efécts, but that information to date has not been listed as a side effect on the nhs website or on the medicine leaflet.


curlyks2

1,076 posts

175 months

Saturday 31st August 2019
quotequote all
Ask the Yellow Card scheme why it isn't listed already?

phumy

5,827 posts

266 months

Saturday 31st August 2019
quotequote all
How can you confirm its linked to the drug, it could be something completely seperate that has hit you?

philv

Original Poster:

5,373 posts

243 months

Saturday 31st August 2019
quotequote all
phumy said:
How can you confirm its linked to the drug, it could be something completely seperate that has hit you?
Of course it could.

But -
Side effects started shortly after taking medicine.
Tne yellow website lists well over 600 reports of neurological side affects.
There are other mentions of the medicine and my specific neurological condition being linked on various internet sites.

All proves nothing for certain.
But certainly worth mentioning in warnings.

However, if i thought i might have ended up with a serious life degrading neurological condition, i would have asked for a different medicine.
It would not be tne first time i have avoided a certain treatment due to risks involved.



Mr Pointy

13,355 posts

188 months

Saturday 31st August 2019
quotequote all
Can you say which drug caused the problem?

philv

Original Poster:

5,373 posts

243 months

Saturday 31st August 2019
quotequote all
Mr Pointy said:
Can you say which drug caused the problem?
Lansoprazole.
Taken for acid reflux.

Knowing what i know now, i would have persisted with tne gavisgon.

knk

1,340 posts

300 months

Saturday 31st August 2019
quotequote all

philv

Original Poster:

5,373 posts

243 months

Saturday 31st August 2019
quotequote all
Ftomcat said:
What is the condition?

Just to clarify - you would have chosen not to take the drug if you'd known that there was a ridiculously small chance of you developing this one particular condition? Assuming of course , as it has been pointed out, this ain't a coincidence.

"Neurological" can mean anything from a stroke to a headache. 600 reported incidents out of the millions and millions of patients without any issues.

I assume you read the patient information leaflet and were ok with the risks of the side effects listed (as they were listed they are deemed to be more common than your anectodal neurological conditon). I assume this means the serious side effects too.

Odd that you were ok with all of the following but not with the even rarer condition you have apparently developed.

Common (affects up to 1 in 10 people)

headaches, feeling dizzy or tired, or a general feeling of being unwell
diarrhoea, constipation, stomach pains, feeling sick (nausea) or being sick (vomiting), wind
dry or sore mouth or throat, benign polyps in the stomach
skin rash, itching
changes in the way your liver is working (shown by a blood test)

Uncommon (affects up to 1 in 100 people)

low mood (depression)
joint or muscle pain
water retention which may cause swollen arms or legs
fracture of the hip, wrist or spine (if lansoprazole is used in high doses and over a long period of time)
changes in blood cell counts

Rare (affects up to 1 in 1000 people)

fever
feeling restless, drowsy or confused
seeing or hearing things which are not there (hallucinations)
numbness, tingling, pricking, burning or creeping on the skin (paraesthesia)
difficulty sleeping (insomnia)
problems with your vision
feeling dizzy, possibly with a “spinning” feeling (vertigo)
a change in the way things taste, loss of appetite, inflammation of your tongue (glossitis)
skin reactions such as burning or pricking feeling under the skin, bruising, red or purple spots which may be itchy or blister.
excessive sweating
being more sensitive to the sun than usual
hair loss (alopecia)
trembling
feeling tired, faint, dizzy, having pale skin. These could be symptoms of anaemia.
kidney problems
pancreatitis
inflammation of the liver (may be seen as yellow skin or eyes)
swelling of the breasts in men, being unable to get or keep an erection (impotence)
candidiasis fungal infection, such as thrush, which may affect your esophagus (food pipe)
angioedema; You should see your doctor immediately if you experience symptoms of angioedema, such as swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breathe.

Very rare (affects up to 1 in 10,000 people)

severe hypersensitivity reactions including shock. Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a fall in blood pressure
inflammation of your mouth (stomatitis)
colitis (bowel inflammation)
changes in test values such as sodium, cholesterol and triglyceride levels
very severe skin reactions with reddening, blistering, severe inflammation and skin loss
very rarely lansoprazole may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately.
A blood test will be taken to check possible reduction of white blood cells (agranulocytosis).

Not known (frequency cannot be estimated from the available data)

rash, possibly with pain in the joints
skin-related forms of lupus or a lupus rash
If you are on lansoprazole for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
Visual hallucinations


Shame the ambulance chaser solicitor wouldn't work out a way for you to sue the doctor. But again odd you were ok with :

"severe hypersensitivity reactions including shock" which is clearly listed on the piece of paper inside the lansoprazole box, and seems it may result in death (!).

I think next time you ask the doctor to go through every single side effect on that list along with the even rarer ones that noone can predict such as your neurological condition.

I hope you can find someone to blame and compensate you accordingly.

Edited by Ftomcat on Saturday 31st August 13:30
Pistonheads can be a wonderful community, full of helpful people and advice.
Then of course there are those who just like to be contrary and argumentative.

amongst tne conditions above, how many are as serious as neurological conditions such as peritheral neuropathy?
How many are likely to result in not being able to walk?
To lose sexual function?
Et etc etc

How many of tnose conditions appear as one of the very few questions when applying for insurance?
They ask about neurological conditions as they are a damn site more serious than headaches.

I am also having other problems with a current insurance as now that i have developed a neurological condition tne insurance company can’t make a decision on an unrelated matter.
This is becase neurological conditions can affect lifespan.

How many of those listed above fall into that category?

Where does it state you may get a neurological condition that may severely degrade your quality of life for tne rest of your life?




philv

Original Poster:

5,373 posts

243 months

Saturday 31st August 2019
quotequote all
I also don’t consider close to 7 in every 10 thousand people developing neurological side affects as miniscule.
(Guestinating 1 million prescriptions per year and 700 cases of neurological side affects).

Assume many cases probably go unreported, it could well be 1 in 1000.

I still have some left.
Would you like to take a high dose as i was prescribed?

anonymous-user

83 months

Saturday 31st August 2019
quotequote all
philv said:
I also don’t consider close to 7 in every 10 thousand people developing neurological side affects as miniscule.
To put this in context a little, I was chatting to a consultant surgeon the other day and he said he's not even obliged to mention any risk from surgery of less than 1:100.

philv

Original Poster:

5,373 posts

243 months

Saturday 31st August 2019
quotequote all
Badda said:
philv said:
I also don’t consider close to 7 in every 10 thousand people developing neurological side affects as miniscule.
To put this in context a little, I was chatting to a consultant surgeon the other day and he said he's not even obliged to mention any risk from surgery of less than 1:100.
Which is obviously rediculous.

Happy to have that botox treatment with a death rate of 1 in 101 not revealed?

Take 10 medicinnes in your lifetime at odds of 1000 to 1.
Might be 1 in a 100 chance of getting a life changing condition.

I’d rather have taken gavisgon for a lot longer rather than risk tne 1 in 1000.



Mastodon2

14,324 posts

194 months

Saturday 31st August 2019
quotequote all
Reporting of deaths are mandatory as a legal requirement. Where medical devices are concerned, any instance of the use of the device that causes a serious deterioration of patient health resulting in the need for medical intervention must be reported under law too. I would expect pharmaceuticals to have very similar reporting requirements, although I have never worked in a regulatory capacity in pharma, I'd imagine someone else can confirm it.

anonymous-user

83 months

Saturday 31st August 2019
quotequote all
I've had drugs with serious side effects. In the end the side effects are worse than the condition being treated.

My experiences are doctors give little sts to what they prescribe, whatever the latest NHS salesmen has listed for them.

They do cursory checks and basically left to fend for yourself. They get you to sign disclaimer to cover their arse.

Unfortunately you have learnt the hard way drugs don't always get it right, but pharma is a billion pound industry and will always win.

272BHP

6,910 posts

265 months

Saturday 31st August 2019
quotequote all
This is always the problem with drugs.

All drugs are bad for you, It is just a trade off as to whether the good effects outweigh the bad.

I take the same drug, maybe once a week but sometimes every day if I am on holiday and making a pig of myself. I really need to try and eat better and wean myself off them.

anonymous-user

83 months

Saturday 31st August 2019
quotequote all
Thesprucegoose said:
My experiences are doctors give little sts to what they prescribe, whatever the latest NHS salesmen has listed for them.

They do cursory checks and basically left to fend for yourself. They get you to sign disclaimer to cover their arse.
This is bks.

anonymous-user

83 months

Saturday 31st August 2019
quotequote all
Badda said:
This is bks.
15+ years of experience. Pityriasis rubra pilaris .

Acitretin, Methotrexate, cyclosporine , corticosteroids and calcipotriol.

I could go on about prescribed treatments damaging and causing more harm then the diseases. Prescribed doses so high I could bearly function with months between visits with little support, to the point i thought i was having a breakdown.

I could go about GPs prescribing for years steriod creams that caused my skin to thin amongst other things. I'm a rare case but it highlights certain failings, similar to the op advised can have serious issues.

pavarotti1980

6,329 posts

113 months

Monday 2nd September 2019
quotequote all
Thesprucegoose said:
I've had drugs with serious side effects. In the end the side effects are worse than the condition being treated.

My experiences are doctors give little sts to what they prescribe, whatever the latest NHS salesmen has listed for them.

They do cursory checks and basically left to fend for yourself. They get you to sign disclaimer to cover their arse.

Unfortunately you have learnt the hard way drugs don't always get it right, but pharma is a billion pound industry and will always win.
To concur what Badda says. you are talking complete bks

RTB

8,273 posts

287 months

Monday 2nd September 2019
quotequote all
Report it to the manufacturing company, they collect all adverse event data and look for any potential signals in the patient population.

I don't mean to belittle what you're suffering but you're going to have an impossible time proving that your neurological condition was as a result of the proton pump inhibitor you took. Millions (hundreds of millions) of people take PPIs every day, in that population there will be every adverse event you can think of, 99.9% of which will have nothing to do with the drug.