NxStage Aluminum Contamination: Is Rockwell Medical Inc. At Fault

[Hemodoc]

http://www.hemodoc.info/2014/06/nxstage-aluminum-contamination-is-rockwell-medical-at-fault-1.html

[Angiepkd]

Thank you, Hemodoc!  This sheds more light on who may be responsible for this aluminum fiasco.

[Speedy1wrc]

Excellent article.

When I spoke with NxStage, while not confirming it was an outsource issue, it was hinted at. It think one phrase was, "We'll continue to work with our vendors...".

I had asked them for a public statement to define what their next steps would be and promised I would get one. I have yet to receive anything.


Out of curiosity, if you had any symptoms, have they gotten any better? I still have a horrible metallic taste Nd it seems worse now than before. My knees are still very weak, but my fingers possibly are a bit better. Every day I try to take an inventory of my symptoms to see if any are improving or not.

My next aluminum level test should be tomorrow in clinic.

[Hemodoc]

Excellent article.

When I spoke with NxStage, while not confirming it was an outsource issue, it was hinted at. It think one phrase was, "We'll continue to work with our vendors...".

I had asked them for a public statement to define what their next steps would be and promised I would get one. I have yet to receive anything.


Out of curiosity, if you had any symptoms, have they gotten any better? I still have a horrible metallic taste Nd it seems worse now than before. My knees are still very weak, but my fingers possibly are a bit better. Every day I try to take an inventory of my symptoms to see if any are improving or not.

My next aluminum level test should be tomorrow in clinic.

I have a HORRIBLE metallic taste, but it is likely it came from my Calcitriol that Fresenius insisted I use instead of Zemplar. I had them switch back to Zemplar and my labs and the taste improved. The Metallic taste may be from another source and Calcitriol is known for that side effect. Just my own experience. Now, granted, at the same time I had the metallic taste so bad, my aluminum was at 21 which is the highest I have had. So, you may need to explore that a bit more. You may also consider seeing a toxicologist to evaluate you as well since Aluminum is not something many nephrologists have any experience with at this time. I no longer have any metallic taste so I can't say exactly what the cause is at this point. Aluminum, or Calcitriol? I don't know.

[Zach]

I have a HORRIBLE metallic taste, but it is likely it came from my Calcitriol that Fresenius insisted I use instead of Zemplar. I had them switch back to Zemplar and my labs and the taste improved. The Metallic taste may be from another source and Calcitriol is known for that side effect. Just my own experience. Now, granted, at the same time I had the metallic taste so bad, my aluminum was at 21 which is the highest I have had. So, you may need to explore that a bit more. You may also consider seeing a toxicologist to evaluate you as well since Aluminum is not something many nephrologists have any experience with at this time. I no longer have any metallic taste so I can't say exactly what the cause is at this point. Aluminum, or Calcitriol? I don't know.

Speaking of Calcitriol, don't look now but Rockewll is about to get into that market as well:

http://www.rttnews.com/2340203/rockwell-medical-gets-fda-approval-for-calcitriol-quick-facts.aspx

Rockwell Medical Gets FDA Approval For Calcitriol

6/23/2014 8:23 AM ET

Rockwell Medical Inc. (RMTI: Quote) announced that the FDA has approved the company's Supplemental Abbreviated New Drug Application or sANDA to manufacture Calcitriol. Calcitriol is Rockwell's low-cost generic active vitamin D drug.

".......our long-standing commercial presence in the hemodialysis market, built via our successful concentrate business, has enabled us to develop strong relationships with our customers. We believe Rockwell is uniquely positioned to generate dynamic sales growth by offering the dialysis market the original, low-cost generic vitamin D injection in vials. We are targeting commercial launch for year end," said Robert Chioini, Founder, Chairman and Chief Executive Officer of Rockwell.

The company noted that Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. Calcitriol when administered by bolus injection is rapidly available in the blood stream.

###

[Angiepkd]

 I don't think I have any more symptoms.  No metallic taste, no more brain fog.  I am now almost 4 months post tx, though.  I am guessing the new kidney is responsible for most of these changes.  I am going to ask my transplant neph again about testing my aluminum levels.  Just for my own peace of mind if nothing else.  He wasn't keen on the idea when I asked him last time, and the CNP mentioned something about the lab not having blue top tubes?  I told her I could bring my own ; ). She was not amused. I am going to ask when I have labs drawn tomorrow if they have the blue tops.  I am betting they do.  Let us know your results, Speedy.  Hopefully, they are much lower.

[obsidianom]

I have a HORRIBLE metallic taste, but it is likely it came from my Calcitriol that Fresenius insisted I use instead of Zemplar. I had them switch back to Zemplar and my labs and the taste improved. The Metallic taste may be from another source and Calcitriol is known for that side effect. Just my own experience. Now, granted, at the same time I had the metallic taste so bad, my aluminum was at 21 which is the highest I have had. So, you may need to explore that a bit more. You may also consider seeing a toxicologist to evaluate you as well since Aluminum is not something many nephrologists have any experience with at this time. I no longer have any metallic taste so I can't say exactly what the cause is at this point. Aluminum, or Calcitriol? I don't know.

Speaking of Calcitriol, don't look now but Rockewll is about to get into that market as well:

http://www.rttnews.com/2340203/rockwell-medical-gets-fda-approval-for-calcitriol-quick-facts.aspx

Rockwell Medical Gets FDA Approval For Calcitriol

6/23/2014 8:23 AM ET

Rockwell Medical Inc. (RMTI: Quote) announced that the FDA has approved the company's Supplemental Abbreviated New Drug Application or sANDA to manufacture Calcitriol. Calcitriol is Rockwell's low-cost generic active vitamin D drug.

".......our long-standing commercial presence in the hemodialysis market, built via our successful concentrate business, has enabled us to develop strong relationships with our customers. We believe Rockwell is uniquely positioned to generate dynamic sales growth by offering the dialysis market the original, low-cost generic vitamin D injection in vials. We are targeting commercial launch for year end," said Robert Chioini, Founder, Chairman and Chief Executive Officer of Rockwell.

The company noted that Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. Calcitriol when administered by bolus injection is rapidly available in the blood stream.

###

REMEMBER THIS POST!!!

PLEASE READ , BY DR. O. IMPORTANT
« on: May 23, 2014, 11:03:01 AM »   

--------------------------------------------------------------------------------
I IMPLORE ALL DIALYSIS AND RENAL PATIENTS TO READ THE THREAD ON NXSTAGE ONTHE TOPIC " SAK RECALL" .PAGE 4  IS THE MOST IMPORTANT.
YOU WILL FIND OUT HOW DIALYSIS PATIENTS WERE CONTAMINATED BY ALUMINUM IN DIALYSATE FOR 9 MONTHS AND HOW THE COMPANY MANUFACTURING IT IS ROCKWELL . ROCKWELL IS PUTTING OUT  NEW DRUG FOR HEMOGLOBIN FOR KIDNEY PATIENTS THAT WAS ALLEGED TO NOT WORK. THEY HAVE SUNK OVER $60 MILLION INTO IT . THEY ALSO PRODUCE A GENERIC CALCITRIOL.  THEY HAVE SOME BAD PRESS.
NXSTAGE SIGNED ON WITH THEM FOR DIALYSATE AND RIGHT AFTER THE PROBLEM DEVELOPED.   WATCH OUT .   
ALL RENAL PATIENTS SHOULD SEE THIS .
AS THIS NEW DRUG WILL GO INTO THE DIALYSATE IN CLINICS IN CENTER, IT COULD EFFECT EVERY DIALYSIS PATIENT.


'Rockwell’s drug Soluble Ferric Pyrophosphate (SFP) is an iron salt administered to dialysis patients through dialysate to replace the iron lost during dialysis'
 

[jeannea]

Angiepkd, I would think they would have the different tubes. Why not? Although sometimes if they draw your blood in transplant clinic they only bring along what is already needed not extra.

[Hemodoc]

I have a HORRIBLE metallic taste, but it is likely it came from my Calcitriol that Fresenius insisted I use instead of Zemplar. I had them switch back to Zemplar and my labs and the taste improved. The Metallic taste may be from another source and Calcitriol is known for that side effect. Just my own experience. Now, granted, at the same time I had the metallic taste so bad, my aluminum was at 21 which is the highest I have had. So, you may need to explore that a bit more. You may also consider seeing a toxicologist to evaluate you as well since Aluminum is not something many nephrologists have any experience with at this time. I no longer have any metallic taste so I can't say exactly what the cause is at this point. Aluminum, or Calcitriol? I don't know.

Speaking of Calcitriol, don't look now but Rockewll is about to get into that market as well:

http://www.rttnews.com/2340203/rockwell-medical-gets-fda-approval-for-calcitriol-quick-facts.aspx

Rockwell Medical Gets FDA Approval For Calcitriol

6/23/2014 8:23 AM ET

Rockwell Medical Inc. (RMTI: Quote) announced that the FDA has approved the company's Supplemental Abbreviated New Drug Application or sANDA to manufacture Calcitriol. Calcitriol is Rockwell's low-cost generic active vitamin D drug.

".......our long-standing commercial presence in the hemodialysis market, built via our successful concentrate business, has enabled us to develop strong relationships with our customers. We believe Rockwell is uniquely positioned to generate dynamic sales growth by offering the dialysis market the original, low-cost generic vitamin D injection in vials. We are targeting commercial launch for year end," said Robert Chioini, Founder, Chairman and Chief Executive Officer of Rockwell.

The company noted that Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. Calcitriol when administered by bolus injection is rapidly available in the blood stream.

###

Yes, and I believe DaVita gets all of their dialysate for in-center treatments from Rockwell as well. They impact a large segment of our dialysis population. If Triferic is approved, it could potentially be close to 100% of the US dialysis market. That is pretty scary for a company that has  questionable  ethics from the reports I have read as well as questionable quality controls. The amazing thing is hardly anyone has heard of this company as of yet.

[Speedy1wrc]

I do not use Calcitriol nor Zemplar. I have had the metallic taste for over a year. It started back with the first contaminated SAK's. It got a bit better when I was on bags during the PAK fiasco, but now back on SAK's it has gotten worse. A-B-A

[Hemodoc]

I do not use Calcitriol nor Zemplar. I have had the metallic taste for over a year. It started back with the first contaminated SAK's. It got a bit better when I was on bags during the PAK fiasco, but now back on SAK's it has gotten worse. A-B-A

I will be getting my labs next week. If the aluminum is still elevated or going up, I will demand the bags as well. FMC switched me over last year against my wishes, but with little choice but "comply." If NxStage has not returned to their prior standards, then they have not yet learned anything. If they think that they can just adhere to K/DOQI guidelines of 10 mcg/liter, they are not dealing with reality. Not when Purac has levels of 01. ppm in their lactate products. Lactate appears to be what is the issue. I didn't see in my review of the Rockwell documents that they had manufactured lactate dialysate previously.

Bottom line, we still have much more we need to know about this whole mess. Not good news in your reports today. I had started to gain a bit of trust in them again. Maybe that was misplaced. I hope I am wrong since we need NxStage healthy for marketplace competition among home dialysis machines. We have had too much experience already with limited market choices.  Not good news at all. Sadly, it may simply be a matter of profit that is at  hand. That is an old, old story with dialysis unfortunately.

Thanks for the information, but that is not at all good news. My Hb is the lowest it has ever been. I don't look forward to considering deferoxamine, but I also don't want to have to go on EPO. I haven't used that except a couple of weeks in my first couple of months on dialysis. I promptly stopped that. A couple of days later, the FDA warning confirmed my worries over EPO. They didn't say anything to me after the FDA warning.

Looks like is continues. I would hate considering going to the Baby K. I don't want to consider that route at this time.  Not good, but thank you.

[Speedy1wrc]

At our center the choice of bags or SAK's is primarily ours. If the supply water has high aluminum then the choice becomes bags. I spoke at length with my nurse today and as a team we are tacking this. Davita is walking the straight and narrow with their threshold for normal aluminum being 40. They otherwise are keeping quiet internally about it. They did however notify the centers about the Globe article before it came out which puzzles me. I am wondering how they found out about it? They knew the content before it hit the wires.

I did hear from one patient who said Vitamin C helped her husband. I will remain hesitant until I hear another similar experience.

You've got my attention...EPO issues?

[obsidianom]

At our center the choice of bags or SAK's is primarily ours. If the supply water has high aluminum then the choice becomes bags. I spoke at length with my nurse today and as a team we are tacking this. Davita is walking the straight and narrow with their threshold for normal aluminum being 40. They otherwise are keeping quiet internally about it. They did however notify the centers about the Globe article before it came out which puzzles me. I am wondering how they found out about it? They knew the content before it hit the wires.

I did hear from one patient who said Vitamin C helped her husband. I will remain hesitant until I hear another similar experience.

You've got my attention...EPO issues?

I give my wife vit c daily and have for years. It didnt help the aluminum at all. It still is at 44.

[Speedy1wrc]

For me Vitamin C was causing an increase in BP. I do take a daily multivitamin which contains 100% C. The addition of a Super B which contained C (I believe significantly more than 100%) was not beneficial.

How long has her level been 44? My level was in the high teens to 20's for almost a year. I am the lowest here locally.if my level drops significantly over the next month or so, then all local patients will be going to bags.

[Hemodoc]

Vitamin C supplementation in ESRD is simply dangerous from oxalate. I would discuss this with your nephrologist BEFORE you take these supplements.

[obsidianom]

Vitamin C supplementation in ESRD is simply dangerous from oxalate. I would discuss this with your nephrologist BEFORE you take these supplements.

I agree. We do the vit c at 250 mg with our nephrologist ok.  There is a lot of literature on dialysis reducing vit c in the body. From what I have read 250 mg is a safe dose . Above that could be dangerous.