Taking Legal Action against Drug Manufacturer?

[AndBreathe]

@mrspuddleduck this is exactly what happened to me. My blood sugars were 7 on admission to hospital but my ketones were 5++++ and my blood PH was 7.0 which is classed as a medical emergency. This is why this drug is dangerous. I was very nearly sent home and it was only because an on call GP was worried about the ketones that they begrudgingly admitted me to the ward for further blood tests. The blood sugar readings can mask the damage the drug is doing behind the scenes. I know I keep banging on about it but all the manufacturer has to do is recommend to prescribers that ketone test strips are given to patients at least for the first 2-4 weeks taking the medicine.

If the issues were uncovered a couple of weeks after you started on the meds, and you were ill within 4 weeks of starting the drug (forgive me if I misunderstand that part), how was the manufacturer supposed to tell you about the issue? How would they know you were taking it? Again, I come back to the prescriber; only they would know, at that stage what you had been prescribed.

Again I say I think you have been extremely unlucky in a couple of areas, which doesn't take away from the fact that you became very ill and are (naturally) angry about that.

I'm not an unsympathetic person. I'm just reading what you are telling me in this thread, but I'll comment no further.

 

[Michele01]

If the issues were uncovered a couple of weeks after you started on the meds, and you were ill within 4 weeks of starting the drug (forgive me if I misunderstand that part), how was the manufacturer supposed to tell you about the issue? How would they know you were taking it? Again, I come back to the prescriber; only they would know, at that stage what you had been prescribed.

Again I say I think you have been extremely unlucky in a couple of areas, which doesn't take away from the fact that you became very ill and are (naturally) angry about that.

I'm not an unsympathetic person. I'm just reading what you are telling me in this thread, but I'll comment no further.

@AndBreathe please comment further. All comments are welcome. Issues were reported with this drug in January in the US and the FDA reported incidents of DKA. So the issues were known at least 7 months before I became ill. There was an official warning issued in the uk on 12 June (I was prescribed them on the 9th and saw my consultant 2 weeks later complaining of extreme tiredness. He put it down to running higher levels (around 10). So the manufacturers were well aware of the problem but prescribers may not have been.

 

[tim2000s]

@Michele01 I think your best bet is to see whether you can join the class action in the US.

 

[Homer]

Ketones is what you would expect from an undiagnosed T1 (fat burnt to obtain energy), this is not dangerous. Ketone production is not unhealthy. It only becomes dangerous when blood sugars rise (well above the 7 mark that you were quoting, >15) and then becomes DKA totally different to ketone production. You seem to be saying that your blood sugar was ok but the ketones were high. As previously stated I think you were misdiagnosed as T2 when in fact you were T1, you would have to prove medical negligence.

 

[robert72]

Ketones is what you would expect from an undiagnosed T1 (fat burnt to obtain energy), this is not dangerous. Ketone production is not unhealthy. It only becomes dangerous when blood sugars rise (well above the 7 mark that you were quoting, >15) and then becomes DKA totally different to ketone production. You seem to be saying that your blood sugar was ok but the ketones were high. As previously stated I think you were misdiagnosed as T2 when in fact you were T1, you would have to prove medical negligence.

But the dangerous part of DKA is the pH level of the blood and @Michele01 was too acidic, even with normal'ish blood sugars

 

[phoenix]

it is very wrong to say that DKA only occurs at high glucose levels. It can and does occur at lower levels. It has been demonstrated to happen with this drug, It's called Euglycaemic (or sometimes normoglycaemic) DKA and as Robert says, it is the acidosis that makes it dangerous condition.
Even without this drug it can occur it's not that common but it certainly happens( more common in pregnancy and sickness when lack of food or vomiting can trigger it) http://www.pjms.com.pk/issues/janmar08/article/bc2.html

 

[Michele01]

@Michele01 I think your best bet is to see whether you can join the class action in the US.[/QUOT

@tim2000s unfortunately I phoned the US lawyers and they're not interested if you're in the UK

Ketones is what you would expect from an undiagnosed T1 (fat burnt to obtain energy), this is not dangerous. Ketone production is not unhealthy. It only becomes dangerous when blood sugars rise (well above the 7 mark that you were quoting, >15) and then becomes DKA totally different to ketone production. You seem to be saying that your blood sugar was ok but the ketones were high. As previously stated I think you were misdiagnosed as T2 when in fact you were T1, you would have to prove medical negligence.

@Homer Ketones in diabetics (type 1 or type 2) are potentially very serious. Everybody can have a low level of ketones (especially in the morning) but once these get over a certain level, they don't just fat burn, they make your blood acidic and that's when the damage starts as it begins to attack your organs. The body needs a strict PH of around 7.30 - 7.45. Any slight deviation either way can be dangerous. Death can occur at 7.0 and under. My PH as stated above was in that range. I was not let out of hospital until my ketones were 2+ and even then, they weren't happy and would have preferred to see them at 1+ at the most.

There are two types of diabetic ketoacidosis (as far as I can tell) - one where you have high blood glucose levels and the other, where blood glucose levels are relatively normal (which is what I had).

 

[mrspuddleduck]

@Michele01 this may be helpful to you
http://bjdvd.co.uk/index.php/bjd/article/view/104/223.

 

[Scouser58]

@tim2000s thank you so much for the additional information. I hadn't found the Medscape paper during my search which is very useful.

I agree, I may have been T1 or T1.5 all along BUT what if these tablets damaged my pancreas and turned me from a Type 2 to a Type 1/1.5? I would think that's a possibility but don't know. I'd love to "speak" with others who have had a similar experience but I think we're (thankfully) few and far between in the UK. I know that in the US there are class actions now against the manufacturers.

Hello Michele01, you asked about reporting side affects from a new medication,
There is the system of the Yellow Form,,,in which you report everything that has happened to you since taking the drug,,,,you also have to inform your gp of the side effects,,,,and when you have completed the form you send it to the address on the form,,, It does not matter about other people has success or not,,,,it is your right to report the side effects that you suffered. It does not matter about being T1 or T2,
your gp prescribed the medication for you and the condition that he wanted to treat,,,your gp will also be concerned about the effects this medication had on you,,,consult with the gp,,,,they might have reported the side effects to who ever they do ,,,,,ttfn from Karen.

 

[Michele01]

Hi Karen - thank you but the Consultant at the hospital completed the yellow card so all of that has been done. It was a consultant (a different one) that prescribed the Forxiga. I am more interested in ensuring the manufacturers change their advice to prescribers - that's my main aim. Thank you for your input.

 

[Michele01]

@Michele01 this may be helpful to you
http://bjdvd.co.uk/index.php/bjd/article/view/104/223.

That's brilliant. Thank you @mrspuddleduck

 

[susananne1969]

Hi, I'm T2 and have been given this drug in conjunction with metformin (sr) and gliclazide. It has brought down my sugar level but reading this tread has concerned me.....should I be taking dapagliflozin??

Any advice would be greatly appreciated.

 

[Molly56]

Hi, I'm T2 and have been given this drug in conjunction with metformin (sr) and gliclazide. It has brought down my sugar level but reading this tread has concerned me.....should I be taking dapagliflozin??

Any advice would be greatly appreciated.

@susananne1969 ...my partner is T2 and has been taking dapagliflozin for about six months now with no serious side effects....I too was worried about it when I read the warnings posted here on the forum....he is also on metformin and was on gliclazide but was advised to stop the gliclazide when taking the dapagliflozin ....this I think was because he is overweight and I think the gliclazide can lead to weight gain as one of its side effects.....the dapagliflozin was introduced to lower blood sugar but also to potentially lose some of the excess weight..this is going down slowly but no real dramatic change in blood sugar as far as I can tell.....he is also now on insulin so not sure or convinced how the whole combination is really working or not...

My advice would be if you are worried speak to your diabetic team or speak to a pharmacist (pharmacists can often give you good advice about potential drug interactions for the combination you are on)...be aware of the issues raised here on the forum especially in terms of testing for ketones as that seems to be a key indicator of any potential problems with this medication....as mentioned in my earlier post though my partner was told that this was not necessary unless he was feeling particularly unwell.....what have you been told by your diabetic nurse....how long have you been taking this particular medication combination...

...from what I can glean some people have been ok with this medication and have had good results and a few have had problems as raised on this thread.....being aware is I think the key issue ....and asking someone who deals with your care if you have particular concerns..

 

[Michele01]

Hi, I'm T2 and have been given this drug in conjunction with metformin (sr) and gliclazide. It has brought down my sugar level but reading this tread has concerned me.....should I be taking dapagliflozin??

Any advice would be greatly appreciated.

@susananne1969 I would definitely ask for some urine keytone sticks OR a blood glucose monitor that you can use with blood/keytone sticks. I understand that the keytone measurement using the sticks in the blood glucose monitors are more reliable than the urine ones. However you'd need to test without the monitor telling you to test. My monitor only automatically tells you test when blood glucose is over 15 but that wouldn't have worked for me because my readings were all under 10 when I was in DKA so I would have to random test. If you have extreme tiredness or thirst then you need to talk to your prescriber. If you feel well then you're probably ok but best to get your ketones tested for peace of mind.

 

[susananne1969]

Thanks, I am next at the diabetic clinic to see the doctor in February. I will definitely ask about this as I am tired and have extreme thirst but lower glucose levels.

 

[Michele01]

Thanks, I am next at the diabetic clinic to see the doctor in February. I will definitely ask about this as I am tired and have extreme thirst but lower glucose levels.

@susananne1969 tiredness and extreme thirst are both side effects of Forxiga BUT they're also side effects of DKA also. My glucose levels were low too. I would urge you to get an appointment with your GP tomorrow, take a urine sample and ask them to check for keytones. The chances are you're simply experiencing side effects of the drug but for the sake of a visit to the GP with some urine, it's not worth taking the chance.

 

[astle9]

so 2 weeks ago i was put on forxiga well it was my choice as i cannot be forced to take it, i take metformin, victoza and levier insulin as well so i guess i am at risk here but none of my medical team have said anything about this.

 

[MAFG666]

I am also interested in suing but not just the manufacturer - the UK NHS! I was given prescriptions for metformin by a dr who didn't talk about any side effects what so ever, in fact this surgery employed doctors who didn't even know I had stopped taking them twelve months later: even though my occupation as a Hgv driver means other people may be at risk if I remained at 23.3 blood glucose. It didn't occur to them that I hadn't been back for repeat prescriptions.
The abdominal spasms and the estimated 16-20 ounces of clear jelly I excreted frightened me so much I stopped taking them 5 weeks in.
None of this was explained to me prior to taking them: I felt like another guinea pig style volunteer for these doctors and now resent them. It is my opinion they were gross negligent in the way they dealt with me.

 

[Brewers23]

Ketosis may occur in anyone, typically it is a sign of dehydration, which is why people who have diarrhoea and/or vomiting can have ketones in the urine, typically show as + or ++.
Acidosis is where the blood pH falls below its normal minimum of 7.35 and may be caused by respiratory problems or metabolic problems. If the pH falls below 6.8 then this is incompatible with life.
If Ketones in the urine are +++ or more and the patient is diabetic, then blood gases will be taken to determine whether they are in DKA. In a typical presentation blood glucose levels will be highly elevated, but they may not be.
DKA is a medical emergency, being treated with intravenous fluids and insulin; the potassium levels in the blood are monitored (potassium needs insulin to be transferred to the cells, and insulin is being given therefore potassium in the blood may fall to dangerous levels, this is controlled by changing the i/v fluids to one containing potassium)
DKA may be caused by infection (and may be indicative that the person may be septic), taking certain medication, Heart attack, stroke.
see: https://www.merckmanuals.com/profes...ydrate-metabolism/diabetic-ketoacidosis-(dka).

DKA affects predominantly type 1 but type 2 can slip into DKA (the ratio is approximately 2:1).

If anyone has an adverse reaction to a drug then they can fill in the yellow card online, it doesn't have to be a healthcare professional that does it.
MAFG666, you're directing your anger towards the wrong organisation (the NHS), when a drug is prescribed the onus is on the prescriber to discuss with the patient possible side effects and interactions with other medication the patient may be taking, if they are not sure (and that is quite probable) then they should look up the drug in the BNF. If the reaction you get is not listed in the BNF then you should fill in the online yellow card. A GP is not employed by the NHS, they are self-employed or a partner in an organisation that is contracted to the NHS to provide certain services.

 

[Humma]

The drugs companies do more good than bad ive used there insulin etc for the past 48 years and it has kept me alive since the age of 13 thank God