• E-mail
• Print
• RSS

Off-label use of bile-duct stents raises FDA ire

Device Regulation Alert: Safety, Compliance and Reimbursement News, March 19, 2007

The FDA and makers of bile-duct stents met last week to discuss concerns about off-label marketing. Representatives from between 10 and 20 companies, including Medtronic and Boston Scientific, attended the meeting, according to the St. Paul Pioneer Press.

Biliary stents are approved for opening bile ducts, but the FDA says it has become aware that they are being promoted and used to open vascular arteries, according to the report. They have not been tested or approved for this use, and the FDA says it is receiving increasing numbers of reports of adverse events stemming from the off-label use.

The Wall Street Journal (WSJ) reported that U.S. manufacturers sell about 90% of these stents to catheterization labs for artery use. WSJ also said that the FDA admonished manufacturers for advertising the stents at a recent cardiology meeting, reports the St. Paul Pioneer Press.

According to the report, the companies deny any off-label promotion.

The bile-duct stent news comes just a week after Representative Henry Waxman, (D-CA), chairman of the Committee on Oversight and Government Reform, requested information from Boston Scientific, Cordis Corporation to investigate "concerns about the safety and off-label use of drug-eluting cardiac stents."

• E-mail to a Colleague
• Print
• RSS
• Archive