I Hate Dialysis Message Board
Dialysis Discussion => Dialysis: General Discussion => Topic started by: greg10 on August 22, 2010, 10:21:22 AM
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I have not seen this posted on this site, but there is a letter of warning on the front page of Fosrenol dot com. Fosrenol, or lanthanum carbonate, is a phosphate binder produced by Shire Pharmaceutical Inc.
Basically the FDA sent a warning letter to Shire on November, 2009, warning Shire of false and misleading advertisements, and that Shire is now passing these warnings to patients that "Shire would like you to know that Fosrenol has not been studied to determine its effectiveness on any of these consequences of having too much phosphate in the blood.
In clinical studies, Fosrenol has been found effective in lowering serum phosphate in patients with end stage renal disease."
There are some animal studies (http://"http://ndt.oxfordjournals.org/cgi/reprint/24/6/1790.pdf") to suggest that "Adequate phosphate binding with lanthanum carbonate attenuates arterial calcification in chronic renal failure rats" However, human studies continues and are currently inconclusive.
Fosrenol is a fairly expensive drug, costing about $600 per month of a 3x 1g per day dosage ($6.67 per tablet), usually taken with meals. The market for phosphate binders is estimated to be about $750 million per year in the US.
Dear Patients, Consumers, and Health Care Professionals:
Shire distributed information about Fosrenol® (lanthanum carbonate hydrate) Chewable Tablets that the US Food and Drug Administration (FDA) found to be false or misleading. This information was the topic of a Warning Letter ("Letter") from the FDA in November 2009.
The information appeared in direct mail, in leave-behind materials, and on the Internet on the www.fosrenol.com website. The FDA stated that the information in the direct mail to consumers was misleading because it overstated the effectiveness of Fosrenol by implying that the product can help prevent the consequences of having too much phosphate in the blood (hyperphosphatemia), including mineral deposits in tissues found in the heart, blood vessels, eyes, joints, and skin; bone disease; and heart disease or death. Shire would like you to know that Fosrenol has not been studied to determine its effectiveness on any of these consequences of having too much phosphate in the blood.
In clinical studies, Fosrenol has been found effective in lowering serum phosphate in patients with end stage renal disease.
The Letter noted that the direct mail sent to consumers contained information suggesting that Fosrenol is more effective than other phosphate binder products. Shire would like you to know that Fosrenol has not been shown to be more effective than other phosphate binders.
The Letter also noted that the direct mail sent to consumers contained information suggesting that Fosrenol therapy is generally appropriate for any patient who has too much phosphate in the blood. Fosrenol is approved to reduce serum phosphate in patients with end stage renal disease only.
In addition, the Letter noted that the direct mail sent to consumers did not contain full prescribing information or important risk information associated with the use of the drug. Shire would like to provide you with this Important Safety Information:
If you suffer from acute stomach ulcer, colon inflammation and colon ulcers, Crohn's disease, or bowel obstruction, it is important to know that patients with these conditions were not included in FOSRENOL clinical studies - please discuss with your doctor.
Do not take FOSRENOL if you are nursing or pregnant, or if you are under 18 years of age.
While FOSRENOL has been shown to accumulate in the GI tract, liver, and bone in animals, the clinical significance in humans is unknown.
The clinical studies were too short to conclude that FOSRENOL does not affect the risk of bone fracture or mortality beyond 3 years.
Although studies were not designed to detect differences in risk of bone fracture and mortality, there were no differences demonstrated in patients with FOSRENOL compared to alternative therapy for up to 3 years.
During clinical trials, the most common side effects of FOSRENOL were gastrointestinal, and included nausea, vomiting, and diarrhea. Nausea and vomiting generally lessened over time as patients continued with their treatment.
Patients who stopped treatment usually reported gastrointestinal side effects as the reason for stopping. Other side effects reported in trials included dialysis graft complications, headache, abdominal pain, and low blood pressure.
Be sure to consult your healthcare provider with any questions about your condition or treatment.
For further information on FOSRENOL, please see the attached copy of the Prescribing Information for FOSRENOL which is enclosed for your reference.
If you have any questions about FOSRENOL, please contact Shire at 1-800-828-2088.
Sincerely,
Joseph Schlitz
Vice President, ISP Products and Commercial Integration
Shire Pharmaceuticals, Inc.
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While FOSRENOL has been shown to accumulate in the GI tract, liver, and bone in animals, the clinical significance in humans is unknown.
I think this particular statement is the most troubling of all.
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Luckily we dont have Fosrenol over here :ukflag; unless its named something else?
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Oh yes we do KS, I've been prescribed it. I've got six bottles of 15 enormous tablets.
They just appeared on my medics list, without discussion, so I haven't taken any yet.
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FOSRENOL®=Lanthanum Carbonate
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000298
Before taking lanthanum ...
if you are taking cinoxacin (Cinobac) (no longer available in the US); ciprofloxacin (Cipro); dicumarol; digoxin (Lanoxin);enoxacin (Penetrex) (no longer available in the US); gatifloxacin (Tequin); indomethacin (Indocin); iron salts; isoniazid (INH, Nydrazid); ketoconazole (Nizoral); lomefloxacin (Maxaquin); moxifloxacin (Avelox); nalidixic acid (NegGram) (no longer available in the US); norfloxacin (Noroxin); ofloxacin (Floxin); salicylate pain relievers such as aspirin, choline magnesium trisalicylate (Tricosal, Trilisate), choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others), and salsalate (Argesic, Disalcid, Salgesic); sparfloxacin (Zagam); tetracycline antibiotics such as demeclocyline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Dynacin, Minocin), and tetracycline (Sumycin); or trovafloxacin and alatrofloxacin combination (Trovan) (no longer available in the US), take them 2 hours before or after lanthanum.
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While FOSRENOL has been shown to accumulate in the GI tract, liver, and bone in animals, the clinical significance in humans is unknown.
I think this particular statement is the most troubling of all.
I agree. It is a disgrace that Shire can charge ~$7 a gram, $600 per month and not be able to do a better long term human study. In addition, there is no data as to whether lanthanum carbonate has any beneficial effect for ESRD patients over a phosphorus restricted diet. There is an assumption of benefits without a consideration of long term risks.
FYI, Lanthanum salts are also used as chemical catalysts, in electronics and as an algaecide based on its phosphate binding property. Lanthanum carbonate, although named after a 'rare earth metal' is actually very inexpensive, costing less than 1 cent per gram in purified bulk quantity. That is about 700 to 1000x markup in price by Shire.
Generic Fosrenol is now available outside of the US, although still priced fairly high, it is in the $200/month range for a 3x1g per day treatment. Hopefully better human studies of lanthanum carbonate could be concluded and generic Fosrenol priced under $50/month in the near future.
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FOSRENOL®=Lanthanum Carbonate
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000298
Before taking lanthanum ...
if you are taking cinoxacin (Cinobac) (no longer available in the US); ciprofloxacin (Cipro); dicumarol; digoxin (Lanoxin);enoxacin (Penetrex) (no longer available in the US); gatifloxacin (Tequin); indomethacin (Indocin); iron salts; isoniazid (INH, Nydrazid); ketoconazole (Nizoral); lomefloxacin (Maxaquin); moxifloxacin (Avelox); nalidixic acid (NegGram) (no longer available in the US); norfloxacin (Noroxin); ofloxacin (Floxin); salicylate pain relievers such as aspirin, choline magnesium trisalicylate (Tricosal, Trilisate), choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others), and salsalate (Argesic, Disalcid, Salgesic); sparfloxacin (Zagam); tetracycline antibiotics such as demeclocyline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Dynacin, Minocin), and tetracycline (Sumycin); or trovafloxacin and alatrofloxacin combination (Trovan) (no longer available in the US), take them 2 hours before or after lanthanum.
For many of those (including ciprofloxacin, as I've noted before (http://ihatedialysis.com/forum/index.php?topic=14645.msg257572)), the same is true with Renvela/Renagel, and possibly other phosphorus binders.
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Luckily we dont have Fosrenol over here :ukflag; unless its named something else?
Yeh, we have Fosrenol here. Blokey has been on it for a while; I picked some up from the pharmacy for him this very morning.
;D
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How does Blokey get on with it Popps? What does it taste like? How compatible is it with a post prandial coffee and cognac?
Does he chew it and spit it out like chewing gum and chewing tobacco? :laugh:
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How strange , i thought i had been through the whole list with my dietician ..no mention of this one ! Im on a brand new one ( i believe) its downstairs and i CBA to go get it , so will tell you its name later but ..its a 'gel capsule' !!!!
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How does Blokey get on with it Popps? What does it taste like? How compatible is it with a post prandial coffee and cognac?
Does he chew it and spit it out like chewing gum and chewing tobacco? :laugh:
*chuckles*
But oh my flippin' heck Stoday! I had to go and look up the word prandial (never heard it before) and managed to infect my computer with a nasty virus, despite having top-notch antivirus software installed. Blokey thinks I'm an idiot for Googling it and just picking a site at random when I could have just gone to dictionary.com. D'oh! I promise I won't blame you if I lose everything on my computer, which my *I work in IT and know everything there is to know about computers* husband thinks I may have done. That's what ... oooh, only ten years of bits and bobs. Yikes!
And I still don't know what prandial means.
;D
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How strange , i thought i had been through the whole list with my dietician ..no mention of this one ! Im on a brand new one ( i believe) its downstairs and i CBA to go get it , so will tell you its name later but ..its a 'gel capsule' !!!!
Apparently it's been available in the UK since 2007. Maybe not all areas offer it? (Stoday appears to be in the same general area as us according to his profile.) I know that the pharmacy have a hard time getting hold of one of the medications I picked up today (due to cost, I think) and I know that they don't have a problem getting hold of warfarin, so it's either the Fosrenol or the indigestion pills (I can't remember the name of them and am also in a cba mood!)
;D
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My mind boggles at what you may have thought "prandial" meant. :rofl;
Post prandial = after dinner
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Well i thought prandial was some sort of new telephone service :rofl;
By the way been and looked and i am now trying Phoslo gel caps. Surely i cant be the only one that binders make :puke;. If anyone else is out there ..how have you coped ?
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It does accumulate in the intestine. I have been on it for about 4 years. Last time I had a catscan on intestine the girls asked me if I had recently had a test using the dye . Of course I hadn't so it was the Fosrenol coating the wall.
The little paper also says it is in bone but did't say anything about blood or liver.
Here ,each tab cost $10. I am in the donut(gap) of the drug plan. I cannot afford $30 a day to take this.
My neph has been supplying me with samples for the last 4 years but Dr. Emily said they were discussing changing me and she could supply me with another type binder. This letter may be the real reason . Scary stuff.
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My neph has been supplying me with samples for the last 4 years but Dr. Emily said they were discussing changing me and she could supply me with another type binder. This letter may be the real reason . Scary stuff.
The information about accumulation in the GI tract, liver, and bone in animals has been known since the product came out several years ago. The product warning is on the insert as well as in advertisements and the company web site.
I've posted it several times here on IHD over the years, too.
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