Renagel

Doctor urges withdrawal of Genzyme kidney drug
By Bloomberg News | May 11, 2006

Genzyme Corp.'s kidney-dialysis treatment Renagel may raise the risk of digestive-tract side effects and deaths and should be withdrawn, a doctor said in a petition to US regulators.

Patients who had taken Renagel had a higher rate of obstructions and perforations of the digestive tract than similar drugs, said Charles Nolan, a physician at the University of Texas Health Sciences Center in San Antonio. His petition to the Food and Drug Administration, filed May 4, cited data provided by the seller of a rival drug, Nabi Biopharmaceuticals.

''If it has this side effect, then it needs to be known," said Nolan, who also has consulted for Nabi. ''I am shocked that this data is in the hands of the FDA and they don’t know about it."

Bo Piela, a spokesman for Cambridge-based Genzyme, didn’t immediately return telephone calls.

Thanks gawd I don’t use that anymore…

I do :shock: Thanks Jane! Actually, I was having severe indigestion nights to the point of becoming physically ill. My doctor tried me on Tums instead but calcium was climbing so as of yesterday put me back on the Renagel. It’s not like the indigestion is free either lol if I didn’t have ins. and just a copay it would cost me over 5oo$ a month! Lin.

Over the past few years, I remember other dialysis patients who were doing fine on TUMS almost pleading with their doctor to try the latest thing: Renagel because they read about it on the internet :slight_smile:

By the way, almost everybody who goes on daily nocturnal hemo can throw the phosphate binders in the garbage - totally, not just reduce them, and then go on and eat all the cheese and ice cream they want. The phosphorus number is completely normal, and there’s just no way you can make it go up that much in just one day of normal eating.

Pierre

Another article. It will be so nice to be off binders :roll:


Doctor calls for withdrawal of Renagel
Posted on: 05/11/2006

BOSTON–Dialysis patients using the phosphorus drug Renagel might be at an increased risk of digestive-tract side effects and death, according to a petition filed May 4 to the U.S. Food and Drug Administration by a doctor who has called for the drug’s withdrawal.

Dr. Charles Nolan, of the University of Texas Health Sciences Center in San Antonio , said patients using Renagal had a higher rate of obstructions and perforations of the digestive tract than similar drugs, according to a report by Bloomberg News.

In the petition, Nolan used data provided by Nabi Pharmaceuticals, which sells the rival drug PhosLo. Nolan has consulted with Nabi in the past. “If it has this side effect, then it needs to be known,” he told Bloomberg News. “I am shocked that this data is in the hands of the FDA and they don’t know about it.”

The FDA approved Renagel on Oct. 30, 1998 , to reduce the level of phosphorus in end-stage renal disease patients on dialysis. According to the FDA, the drug should not be used in patients with low phosphorus levels or bowel obstruction.

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Renal bone disease typically takes years to develop but is no fun to have. The best way to avoid complications such as too high calcium from PhosLo or GI problems from Renagel is to follow the advice your doctor and dietitian give you about how much phosphorus is safe for you to eat, read labels, avoid processed foods, and get the best dialysis you can. Being on home hemo, you have much control over how much dialysis you get vs. in-center HD patients who come and go on a schedule that is seldom adjusted. I suspect most of the research is done on in-center HD patients who get 3 hours of dialysis 3 times a week.

To learn about clinical trials on secondary hyperparathyroidism:

http://www.clinicaltrials.gov