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.
While FOSRENOL has been shown to accumulate in the GI tract, liver, and bone in animals, the clinical significance in humans is unknown.
Quote from: greg10 on August 22, 2010, 10:21:22 AMWhile 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.
FOSRENOL®=Lanthanum Carbonatehttp://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000298Before 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.
Luckily we dont have Fosrenol over here unless its named something else?
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?
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' !!!!
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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