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Controversy Over Request to Yank Approval for Renagel

Controversy Over Request to Yank Approval for Renagel2The drug Renagel is at the center of an interesting regulatory controversy right now. A doctor filed a petition with the FDA on May 3 arguing that Renagel should be de-approved or slapped with a drug Renagel ” warning because it is unsafe. Specifically, the petition says that the use of the drug has been associated with an “alarming number of serious and potentially life-threatening adverse gastrointestinal events” but that Renagel’s labeling “fails to even mention intestinal
obstruction or perforation as potential adverse events, let alone warn against them.”

In Renal Business Today, a spokesman for Genzyme, the maker of Renagel, says the petition submitted by the doctor is inaccurate. Moreover, (and here’s where it gets interesting), the article says that Dr. Nolan, who submitted the petition, “served as a consultant for Nabi Pharmaceuticals . . . which sells PhosLo, a rival drug to Genzyme’s Renagel. According to the petition, Nolan said he was not compensated by Nabi or anyone else for submitting the document.”

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