Amgen Inc (AMGN.O: Quote, Profile, Research, Stock Buzz) used a misleading brochure to tout its kidney disease drug Sensipar to patients, U.S. health officials said in a letter released on Wednesday.
"This piece is false or misleading because it omits and minimizes the risks associated with the use of Sensipar and broadens the indication," the Food and Drug Administration said in a letter to Amgen.
The agency asked Amgen to immediately stop using the brochure.
The approved uses of Sensipar include treatment of secondary hyperparathryoidism, or excessive production of the parathyroid hormone, in patients undergoing dialysis for chronic kidney disease.
Amgen said it is working closely with the FDA to address their concerns about the Sensipar patient education brochure.
"We immediately ceased distribution of the brochure. Amgen is committed to responsible marketing that reflects the benefits and risks of our medicines," the company said in a statement.
The FDA letter was posted on the agency's Website here
(Reporting by Lisa Richwine and Deena Beasley; Editing by Bernard Orr)
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