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Sensipar patient brochure misleading, US FDA tells Amgen

This article was originally published in Scrip

Executive Summary

A patient brochure forAmgen's hyperparathyroidism drug Sensipar (cinacalcet) is false and misleading because it omits and minimises risks and broadens the medicine's indication, the US FDAsaid. The brochure omits the serious risk of adynamic bone disease and the need for monitoring of hepatically impaired patients. The presentation of side- effects information minimises the severity, frequency and duration of nausea and vomiting. The promotion also misleadingly suggests Sensipar is indicated for all patients on dialysis, rather than just those who require treatment for secondary hyperparathyroidism with chronic kidney disease. Amgen said it was working with the FDA to address its concerns and has stopped distributing the brochure.



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