FDA Says Amgen Drug Brochure Is False, MisleadingDow Jones
October 29, 2008: 06:59 PM EST
WASHINGTON -(Dow Jones)- The Food and Drug Administration said Wednesday that an Amgen (AMGN) advertising brochure for Sensipar, a drug used in certain kidney disease patients, is "false and misleading."
In a letter to Amgen and posted to the agency's Web site Wednesday, the FDA said a direct-to-consumer patient brochure omits and minimizes risks for the drug and broadens the indication, or possible usage, for the drug.
Sensipar is approved to treat secondary hyperparathyroidism in patients with chronic kidney disease. Hyperparathyroidism is a disorder of the parathyroid glands that causes too much of a hormone involved with maintaining the correct balance of calcium and phosphorus in the body to be secreted.
The FDA said the patient brochure failed to disclose the risk of Sensipar therapy to patients with liver problems and omitted the risk of developing a type of bone disease. The agency also said the brochure minimizes the severity and frequency of less serious events like nausea and vomiting.
The FDA said the brochure suggests the drug should be used by patients on dialysis, which broadens the approved indication for the drug.
"Specifically, Sensipar is not indicated for all patients on dialysis, but only for patients on dialysis who require treatment for secondary hyperparathyroidism with CKD," the FDA said.
The agency said Amgen must stop distributing the brochure and similar materials.
In a statement, Amgen said it has stopped distributing the brochure and is " working closely with the FDA to address their concerns about the Sensipar patient education brochure."
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
http://money.cnn.com/news/newsfeeds/articles/djf500/200810291859DOWJONESDJONLINE001024_FORTUNE5.htm
I Hate Dialysis Message Board
Author
