Watson Pharmaceuticals Inc. circulated a misleading advertisement for anemia drug Ferrlecit that made an unsupported claim and failed to disclose the product’s approved use and risks, U.S. regulators said in a letter released on Friday.
The Food and Drug Administration ordered Watson to immediately stop using the advertising materials, which appeared in the October 2004 edition of the journal Kidney International.
The FDA objected to a Ferrlecit ad on the journal’s back cover that was partly covered by a removable band wrapped around the magazine.
The band did not mention the product by name but contained claims that suggested it was promoting Ferrlecit, the FDA said in the letter to Watson. The FDA viewed the two pieces together as one ad.
“The ad omits the specific indication for the drug and fails to include any risk information,” the FDA letter said.
The agency also took issue with the claim “easy administration,” calling it “misleading at best.” Most patients need to have the drug given intravenously over eight or more dialysis sessions and may require lab tests to monitor iron levels.
Ferrlecit is approved for treating iron-deficiency anemia in patients who are undergoing chronic kidney dialysis and receiving supplemental epoetin therapy.
A spokesman for Watson did not immediately return a call requesting comment.
Revision date: June 14, 2011
Last revised: by Janet A. Staessen, MD, PhD