SGLT2 inhibitors: updated advice on the risk of diabetic ketoacidosis

[Oldvatr]

I have on several occasions asked forum posters who are using this family of diabetes medication if their prescriber has discussed the symptoms of DKA with them in regard to this family of medications. So far none has replied that this happened, so I am starting this thread with the current Government advisory from both the UK and USA. I cannot find any NICE guidelines to GP's covering this aspect but there was an internal assessment report I found that discusses this topic. The report is not for public release. It discusses the reported incidence rates for DKA and acute pancreatis but has no recommendations other than wait for more FDA investigation studies to complete.
The following advisories are released and updated by the regulatory authorities:
https://www.gov.uk/drug-safety-upda...d-advice-on-the-risk-of-diabetic-ketoacidosis

http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm

I really think this should be made into a sticky so it does not get lost. DKA is a potentially life threatening condition that can apparently be triggered by these meds even on lowish bgl levels (10 mmol/l) so is not the same as the classic DKA symptoms where there is very high bgl with it.
@Giverny

The report that the NICE comittee used to base their decision on is available on the web
https://www.nice.org.uk/guidance/ta336/chapter/4-Consideration-of-the-evidence

It is interesting that the Company ran all the tests and presented the findings. The tests were short duration and the only side effect noted in the summary was UTI. The incidence of bone thickening and fracture was not reported, and DKA was not considered. There was no seperate chapter on SAFETY at all, and long term safety did not seem to be a consideration.

The current guidelines for prescription do not mention either of these 'side effects either.
https://www.nice.org.uk/guidance/ta390/chapter/3-Evidence

Edit to add a couple of related topics:
Sglt2 Inhibitors Continue To Be Linked With Amputation Risk In Type 2 Diabetes
https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2696726

And another related study on mortality associated with this medication:
https://jamanetwork.com/journals/ja...t=personalizedcontent&previousarticle=2696726

 

[catherinecherub]

I have stickied your information @Oldvatr as it is something that needs highlighting.

 

[Oldvatr]

I have stickied your information @Oldvatr as it is something that needs highlighting.

Thank you. I felt it needed something especially as the last OP I flagged confirmed they had not been given any special info,
Now we have a central place to keep this info up to date.

 

[Cragwood]

Thank you. I felt it needed something especially as the last OP I flagged confirmed they had not been given any special info,
Now we have a central place to keep this info up to date.

Thank you for posting this as a sticky, I wouldn't like anyone else to go through what I and others have. I believe there have been 120+ cases in the UK, including at least 2 fatalities.

I can see that the online patient information leaflet has been changed to include warnings, but the PIL inside the packets of medication does not include any information and will take time to catch up. I wasn't warned by my prescriber or by the pharmacist. When I went back and queried my symptoms with them I was told it was because the medication was working and my blood sugars were falling. My sugars were running at 3-4 even though I was in DKA. When I went to A&E the doctor was about to send me home even though my ketones were off the scale. I was only when I showed him the warnings from this site on my phone that he ran blood tests and then all hell broke loose!

 

[Oldvatr]

Thank you for posting this as a sticky, I wouldn't like anyone else to go through what I and others have. I believe there have been 120+ cases in the UK, including at least 2 fatalities.

I can see that the online patient information leaflet has been changed to include warnings, but the PIL inside the packets of medication does not include any information and will take time to catch up. I wasn't warned by my prescriber or by the pharmacist. When I went back and queried my symptoms with them I was told it was because the medication was working and my blood sugars were falling. My sugars were running at 3-4 even though I was in DKA. When I went to A&E the doctor was about to send me home even though my ketones were off the scale. I was only when I showed him the warnings from this site on my phone that he ran blood tests and then all hell broke loose!

Thank you for posting this. I was worried that I was appearing to be overly cautious and accused of frightening Newbies with dire warnings. Crying wolf came to my mind often. I am glad this information is now being properly used.

Edit to Add: I am so pleased you had a good outcome to report. You showed preseverence and for that I vote you a Winner.

 

[Cragwood]

Thank you for posting this. I was worried that I was appearing to be overly cautious and accused of frightening Newbies with dire warnings. Crying wolf came to my mind often. I am glad this information is now being properly used.

Edit to Add: I am so pleased you had a good outcome to report. You showed preseverence and for that I vote you a Winner.

Not crying wolf at all! It was your post with the drug safety update that finally convinced the doctor in A&E, so thank you for that. In fact I can't thank you enough!!!

A lot of people use these medications very well and safely, but forewarned is forearmed. @Michele01 gave some great advice about testing for ketones with ketostix and that advice probably saved my life.

 

[ickihun]

I too went to a&e but ketones weren't checked as bg was 9.2 on testing, I guess? I was checked for thrombosis and sent home. I stopped the tablet myself but since I'm not dead maybe I wasn't suffering with Ketoacidosis?

 

[Oldvatr]

I too went to a&e but ketones weren't checked as bg was 9.2 on testing, I guess? I was checked for thrombosis and sent home. I stopped the tablet myself but since I'm not dead maybe I wasn't suffering with Ketoacidosis?

It sounds like A&E only check for ketoacidosis if bgl levels are exceedingly high, which this med sideslips. It gets in under their radar. But you are indeed alive, so probably wasn't this after all. Either way both of us are off this med type, so we can pass the warning on to others. The only other thing to add was that if you came off this because of adverse effects, then the GP should have sent in a yellow card to log it on the drugs advisory database.

 

[ickihun]

It sounds like A&E only check for ketoacidosis if bgl levels are exceedingly high, which this med sidelaps. It gets in under their radar. But you are indeed alive, so probably wasn't this after all. Either way both of us are off this med type, so we can pass the warning on to others. The only other thing to add was that if you came off this because of adverse effects, then the GP should have sent in a yellow card to log it on the drugs advisory database.

Specialist noted thrush for reason of stopping.
Dn will be updated soon, maybe she can encourage true affects as she witnessed my bad leg/foot/toes. I'll update you after my august appointment.
Informing people here is the best I can do now.

 

[billywhiz2]

Thank you. I felt it needed something especially as the last OP I flagged confirmed they had not been given any special info,
Now we have a central place to keep this info up to date.

Thanks for highlighting, I had DKA, two days after you alerted me. I am now off the drug for more reasons than the DKA but already feeling a lot better.

 

[Susiespearish]

Thanks for this advice.I started on this yesterday and was really only warned about not letting myself get dehydrated and the high thrush risk .No warning of potentential DKA .Maybe she thought this wouldn't be relevant to me as my BG's are up in the high twenties but I'm hoping and thought the whole point of this med was that it works and would lower my BG so therefore putting me in the danger zone for a DKA.

 

[ickihun]

Thanks for this advice.I started on this yesterday and was really only warned about not letting myself get dehydrated and the high thrush risk .No warning of potentential DKA .Maybe she thought this wouldn't be relevant to me as my BG's are up in the high twenties but I'm hoping and thought the whole point of this med was that it works and would lower my BG so therefore putting me in the danger zone for a DKA.

The trouble with this drug it disguises DKA as blood meter reads ok bg level but blood/body is suffering with DKA so medical staff don't check for DKA if their meter bg is normal, sometimes.

 

[Brunneria]

Here is a link to the DCUK webpage giving info about these drugs, including the common brand names.
(it occurred to me that people may not realise that the drug they are taking is an SGLT2 inhibitor [Gliflozins])

https://www.diabetes.co.uk/diabetes-medication/sglt2-inhibitors.html

Also worth noticing that as I post this, the side effects listed on that page do not include ketoacidosis, although they list genital and UT infections, hypos, liver damage, breast and bladder cancers and increased cholesterol.

Maybe @Administrator may ask someone on the team to update the info to include ketoacidosis? Thank you in advance, Administrator.

 

[Indy51]

There are now warnings about to be added to these drugs about an increased risk of lower limb amputations. I'd be very wary of taking them

http://www.medscape.com/viewarticle...210_MSCPEDIT&uac=150977BN&impID=1288424&faf=1

 

[ickihun]

There are now warnings about to be added to these drugs about an increased risk of lower limb amputations. I'd be very wary of taking them

http://www.medscape.com/viewarticle...210_MSCPEDIT&uac=150977BN&impID=1288424&faf=1

Have you seen this @Liam1955 ?

 

[ickihun]

@Indy51 my immobility problem started on canagliflozin. I've never been right since!

 

[Liam1955]

Have you seen this @Liam1955 ?

@ickihun - Hmmm interesting article Vicky. (Have kept in my favourites).
This time around on the Dapagliflozin - GP said He would prescribe it for 6 months in the hope of getting my HBA1C down, which the liquid Morphine was responsible for pushing it right up to 76.
Thanks for this Vickyxx

 

[Indy51]

Also adding the warning posted by @Ultramum on another thread about affect of canagliflozin on joints and bone density:

https://www.fda.gov/Drugs/DrugSafety/ucm461449.htm

 

[ickihun]

Also adding the warning posted by @Ultramum on another thread about affect of canagliflozin on joints and bone density:

https://www.fda.gov/Drugs/DrugSafety/ucm461449.htm

Thank you @Indy51 .

I think this is exactly what is happening to me!
Now i just need it reversing!

 

[ickihun]

Been to see a solicitor today. Should know by end of week whether they are going to pursue for damages.
My mobility was very precious to me and my young children.