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.
