Drug-coated Stents Receive Approval from FDA Panel

Tiffany Farr

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Despite recent findings regarding the safety of new drug-coated stents, an FDA panel has given the thumbs up for their use in the some 3 million people who currently already have them implanted. This panel concluded that while there is "unequivocal evidence" that these drug-eluting stents may cause blood clots in patients, the benefits outweigh any safety concerns.

More than 60 percent of the drug-coated devices are implanted in higher-risk and other patients not covered under the FDA-approved label usage. Dr. Donald Baim of Boston Scientific, one of the two manufacturers with U.S. approval to sell these stents, asks that one pose the question, "At the end of the day, the things patients care about- 'Am I more likely to be dead or have a major heart attack?'- the answer is 'no.'"

Of course, drug companies will continue to voice support for their products until proven drastically differently. Those patients needing the stents obviously fall into a category for higher risks for heart attacks and strokes (thus the need for the stents) so more research needs to be done as to whether these devices used to prolong and better one's life can, in actuality, be detrimental in the end.