WARNING IF TAKING FOXIGA/DAPIFLAGIFLOXIN

[Michele01]

Ladies and Gents

I was put on Foxiga 10mg one month ago. 10 days ago I started to feel like I had 'flu, general aches and pains and very very tired plus I was also severely dehydrated despite drinking 3L of water a day. On Monday I was seen by the after hours clinic who found 5+ ketones in my urine. Thankfully the emergency doctor was alarmed and insisted I was seen by the hospital to have my blood gases taken (initially they wanted to send me home). When the blood results came back I was taken straight to the High Dependency unit as I had severe ketone acidosis. So bad that they were worried another 24 hours and I wouldn't have made it.

This has been caused solely by Foxiga. As mentioned in another thread, a medical alert has been issued about this medication BUT doctors are not generally aware yet that you can have normal BM levels but behind that your body is shutting down.

So if you are taking this tablet or have recently been prescribed it PLEASE make sure you get some ketone sticks and test your urine daily. If ketones show get your blood taken. If you start suffering with extreme tiredness and/or dehydration, please do the same.

I now have to inject insulin in the short term and eat lots of carbohydrates to eliminate the ketones.

I've been shaken to the core by this and am still scared and suffering from shock and I would hate for this to happen to anybody else. xxx

 

[Fayefaye1429]

I am so sorry for the rough time you have had

 

[Michele01]

I am so sorry for the rough time you have had

Thank you @Fayefaye1429. xxx

 

[Molly56]

Ladies and Gents

I was put on Foxiga 10mg one month ago. 10 days ago I started to feel like I had 'flu, general aches and pains and very very tired plus I was also severely dehydrated despite drinking 3L of water a day. On Monday I was seen by the after hours clinic who found 5+ ketones in my urine. Thankfully the emergency doctor was alarmed and insisted I was seen by the hospital to have my blood gases taken (initially they wanted to send me home). When the blood results came back I was taken straight to the High Dependency unit as I had severe ketone acidosis. So bad that they were worried another 24 hours and I wouldn't have made it.

This has been caused solely by Foxiga. As mentioned in another thread, a medical alert has been issued about this medication BUT doctors are not generally aware yet that you can have normal BM levels but behind that your body is shutting down.

So if you are taking this tablet or have recently been prescribed it PLEASE make sure you get some ketone sticks and test your urine daily. If ketones show get your blood taken. If you start suffering with extreme tiredness and/or dehydration, please do the same.

I now have to inject insulin in the short term and eat lots of carbohydrates to eliminate the ketones.

I've been shaken to the core by this and am still scared and suffering from shock and I would hate for this to happen to anybody else. xxx

@Michele01 ...thank you for the warning...my partner was started on foxiga about three weeks ago...he was given ketone sticks to use but can't remember why and how often he should use them. He does have reasonably high bs levels in the high to mid teens but that is not unusual for him...he also tends to drink a lot of bottled water so assume that he is hydrated but note your comments on dehydration....will be something to look out for..my concern as always is that he will not recognise the warning signs as he tends to just take to his bed if feeling unwell and not think of testing.
I hope that you have made or will soon make a full recovery and that you get over the shock of this ....just out of interest do I assume that you are no longer taking the forxiga.

 

[furbydoggie]

Ladies and Gents

I was put on Foxiga 10mg one month ago. 10 days ago I started to feel like I had 'flu, general aches and pains and very very tired plus I was also severely dehydrated despite drinking 3L of water a day. On Monday I was seen by the after hours clinic who found 5+ ketones in my urine. Thankfully the emergency doctor was alarmed and insisted I was seen by the hospital to have my blood gases taken (initially they wanted to send me home). When the blood results came back I was taken straight to the High Dependency unit as I had severe ketone acidosis. So bad that they were worried another 24 hours and I wouldn't have made it.

This has been caused solely by Foxiga. As mentioned in another thread, a medical alert has been issued about this medication BUT doctors are not generally aware yet that you can have normal BM levels but behind that your body is shutting down.

So if you are taking this tablet or have recently been prescribed it PLEASE make sure you get some ketone sticks and test your urine daily. If ketones show get your blood taken. If you start suffering with extreme tiredness and/or dehydration, please do the same.

I now have to inject insulin in the short term and eat lots of carbohydrates to eliminate the ketones.

I've been shaken to the core by this and am still scared and suffering from shock and I would hate for this to happen to anybody else. xxx

hi michele01, this is my first post on the forum and I too ended up in A&E in January this year with DKA because of this drug. I was only on the Forxiga for 4 days and became very unwell. Like you the arterial blood gases showed severe ketones despite normal BG levels. IMO this is a very dangerous drug.

 

[Fayefaye1429]

I know this is a stupid question what is it meant to do?

 

[furbydoggie]

I know this is a stupid question what is it meant to do?

Hi fayefaye, I don't know the technical terminology but as far as I know Forxiga takes the glucose out of your bloodstream and forces it out of you body via the kidneys as urine. So it gives better BG readings but what's happening behind the scenes is a bit more sinister for some people :-(

 

[Molly56]

I know this is a stupid question what is it meant to do?

@Fayefaye1429 ...as I understand it it is supposed to prevent sugar from circulating in your blood stream by removing it and excreting it through your urine..that's a very basic explanation...am sure there is a far more scientific explanation somewhere...

 

[Fayefaye1429]

Oh I see yet it can do the opposite oh feels scary to me thank you molly

 

[Fayefaye1429]

Hi Fitbit doggie sorry just seen you reied. Thank you I think I have to agree with you it feels too scary to me

 

[Fayefaye1429]

Furbie

 

[dancer]

My oldest brother was put on it. He was told it's experimental. I must tell him of this possible side effect - though I presume he'd be affected by now if he was susceptible.

 

[Michele01]

@Michele01 ...thank you for the warning...my partner was started on foxiga about three weeks ago...he was given ketone sticks to use but can't remember why and how often he should use them. He does have reasonably high bs levels in the high to mid teens but that is not unusual for him...he also tends to drink a lot of bottled water so assume that he is hydrated but note your comments on dehydration....will be something to look out for..my concern as always is that he will not recognise the warning signs as he tends to just take to his bed if feeling unwell and not think of testing.
I hope that you have made or will soon make a full recovery and that you get over the shock of this ....just out of interest do I assume that you are no longer taking the forxiga.

@Molly56 they have taken me off Foxiga and I'm never allowed to go back on them. For some people this happens, but not all. Your husband MUST test his urine twice a day. He should wee on the ketone stick and check the colour against the tube after 10-15 seconds. Anything higher than 2+ which is the light purple (third one across) he MUST see somebody to check that he's ok. At 2+ you can easily reverse it but any higher you're in trouble IF the Foxiga behind the scenes is making your blood acidic. The symptoms of dehydration are also broadly similar to ketone acidosis so the whole picture gets a bit confusing if you're unwell. I was drinking 3L of water a day and still dehydrated.

I don't wish to scaremonger in any way but this drug is new and they're still finding out about side effects. For some it will be wonderful (like any drug) but for others, it can cause issues. So please impress on your husband that as a newbie to the drug he does need to be vigilant xxx Hope it goes well for him.

 

[Michele01]

hi michele01, this is my first post on the forum and I too ended up in A&E in January this year with DKA because of this drug. I was only on the Forxiga for 4 days and became very unwell. Like you the arterial blood gases showed severe ketones despite normal BG levels. IMO this is a very dangerous drug.

@furbydoggie I am SO sorry to hear that this has happened to you also. I'm so glad that you're well now (assuming you are). You were very very very lucky that they didn't turn you away because your BG levels were normal because I don't think the medical alert had been issued then. You must have been seen by a very investigative doctor. Can I ask what your blood gases were? Mine were 7.0 on admittance and my ketones 5+ but my BM was 7 and 8 ish!!!! I'm now having to inject insulin in the short term and take one Metformin (building to two because I don't tolerate them well). What have you been put on please?

 

[donnellysdogs]

I alerted people on forum with this drug alert from the EU investigating it....

It was sent out to GPs via pulsetoday emails as a news item.

I am so shocked to hear of the dreadful occurences that have been reported here and I so hope that you both will recover to full health. It really saddens me enormously to read what you have both been through.

It isn't just foxriga - there are other similar drugs that are also involved as well.

I can't find my original posting alert to forum members as a link...but it should really be sent out to all GPs and pharmacists as an official MHRA warning..

Please can I ask whether your GPs or yourselves have completed the MHRA side effect alert - this can be done online. It is vitally important this is done as it is the only way that the MHRA will get to hear and act upon this dangerous drug.....

 

[Winnie53]

Here's the US website for the drug... https://www.farxiga.com

No mention what so ever of ketoacidosis on the company's official website for the drug even though the FDA sent out a safety announcement two months ago on May 15, 2015...

FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood - (six SGLTS medications are listed)... http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm

The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors.

Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Do not stop or change your diabetes medicines without first talking to your prescriber. Health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels.

Glad the two of you are okay, and immediately sought medical care.

 

[Michele01]

I alerted people on forum with this drug alert from the EU investigating it....

It was sent out to GPs via pulsetoday emails as a news item.

I am so shocked to hear of the dreadful occurences that have been reported here and I so hope that you both will recover to full health. It really saddens me enormously to read what you have both been through.

It isn't just foxriga - there are other similar drugs that are also involved as well.

I can't find my original posting alert to forum members as a link...but it should really be sent out to all GPs and pharmacists as an official MHRA warning..

Please can I ask whether your GPs or yourselves have completed the MHRA side effect alert - this can be done online. It is vitally important this is done as it is the only way that the MHRA will get to hear and act upon this dangerous drug.....

@donnellysdogs the Consultant treating me at the hospital says that it's a matter of protocol that they alert the relevant parties that deal with this type of issue (I didn't ask for specifics). He's also asked one of his residents to write up my history as a case study and this is being distributed to all hospitals in the Manchester area. He also mentioned having posters made that alert medical professionals (not sure who) about this problem so that nobody is turned away if their BGs are fine. So rest assured, at this end everything is being done that can be done.

Thankfully I saw your post about the medical alert about one hour before I called the out of hours doctors and a nurse at their end did a ton of research and presented it to the out of hours doctor before I got there. I suspect that this wouldn't happen as a rule though and that I was incredibly lucky.

 

[Winnie53]

donnelysdogs, thankfully I saw your post about the medical alert about one hour before I called the out of hours doctors and a nurse at their end did a ton of research and presented it to the out of hours doctor before I got there. I suspect that this wouldn't happen as a rule though and that I was incredibly lucky.

I love hearing reports like this. Well done donnellysdogs and Michele01.

 

[Michele01]

Here's the US website for the drug... https://www.farxiga.com

No mention what so ever of ketoacidosis on the company's official website for the drug even though the FDA sent out a safety announcement two months ago on May 15, 2015...

FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood - (six SGLTS medications are listed)... http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm

The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors.

Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Do not stop or change your diabetes medicines without first talking to your prescriber. Health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels.

Glad the two of you are okay, and immediately sought medical care.

@Winnie53 this is the problem. Foxiga also can make you severely dehydrated which causes fatigue, nausea, difficulty breathing and so do so many other things (which is why I thought I had 'flu). For me, the most dangerous thing about this drug is that the side effects are so similar to ketoacidosis so you're not quite sure what's wrong and in the absence of information on the company's website or pamphlet with the tablets, it would be very easy to miss. For me, I'd been on them for just under 3 weeks with absolutely no side effects apart from mild dehydration (a known side effect) so I didn't put 2 + 2 together until I read @donnellysdogs post with the warning.

Thank you for your good wishes. x

 

[donnellysdogs]

@donnellysdogs the Consultant treating me at the hospital says that it's a matter of protocol that they alert the relevant parties that deal with this type of issue (I didn't ask for specifics). He's also asked one of his residents to write up my history as a case study and this is being distributed to all hospitals in the Manchester area. He also mentioned having posters made that alert medical professionals (not sure who) about this problem so that nobody is turned away if their BGs are fine. So rest assured, at this end everything is being done that can be done.

Thankfully I saw your post about the medical alert about one hour before I called the out of hours doctors and a nurse at their end did a ton of research and presented it to the out of hours doctor before I got there. I suspect that this wouldn't happen as a rule though and that I was incredibly lucky.

Crikey!! You were certainly incredibly lucky.....

I would still report this on the MHRA website though, as its ok the consultant doing posters and warnings but the most important thing he should have done is to inform the MHRA himself. Quite often they GPs and Consultants don't quite simply have time inbetween patients and consultations etc to do so.

I would wholly recommend that you do it.

@Winnie53.. This was an EU concern about inhibitor drugs so may not have fed back to the US yet...(although it should have been).. Red tape etc...

Its not just foxriga involved...