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Corp.'s kidney-dialysis treatment Renagel may raise the risk of digestive-tract side effects and deaths and should be withdrawn, a doctor said in a petition to US regulators.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