Off-label uses of drug-eluting stents is common
Device Regulation Alert: Safety, Compliance and Reimbursement News, May 14, 2007
About half of drug-eluting stents used between 2004 and 2005 were used for off-label purposes, according to two studies in last week's Journal of the American Medical Association (JAMA).
However, the two studies came to different conclusions about whether untested uses of the stents resulted in danger for patients. One study found that compared with on-label use, off-label use of drug-eluting stents is associated with a higher rate of adverse outcomes, such as stent thrombosis.
In the other study, researchers found that adverse events were relatively uncommon with both on- and off-label uses.
An editorial in JAMA discussed the two studies and stressed the importance of systematic data collection for improved device safety.
Go to the JAMA Web site read more.
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