Drug coated stent recall will not occur, but serious safety concerns still exist
Following the meeting of an FDA panel of experts last week, it does not appear that there will be a drug coated stent recall or removal from the market. However, medical experts have still indicated that there are serious safety concerns associated with drug eluting stents. Most patients currently receiving the stents face an increased risk of blood clots, which could lead to heart attacks or death.
>>INFORMATION: Heart stent problems
The FDA panel was convened to review the safety of drug eluting heart stents after recent studies demonstrated an increased risk of blood clots, heart attacks and death associated with the devices. The panel found that when the stents are used as approved, the benefits outweigh the risk. However, it has been estimated that only 20-40% of all drug eluting stents are implanted in patients meeting the profile for which they have been determined to be safe.
Currently, the majority of cases where medicated stents are used to open clogged arteries are considered “off-label”. At the FDA meetings, several presenters who analyzed the latest heart stents data, concluded that there is an increased risk of blood clots associated with these off-label uses. Further drug coated stent studies are necessary to fully evaluate the extent of the the blood clot risk.
Rather than concluding that a drug coated stent recall is necessary to protect the public, the panel has recommended that manufacturer do more to warn the public of these off-label dangers.
Off-label stent uses could include situations where the patient is sicker or has conditions such as diabetes, multiple blockages, or blocked narrow arteries. Some experts indicated that those individuals may do better with heart bypass surgery instead of having a drug eluding stent implanted.
The FDA panel also recommended that individuals take an anti-clotting medication for at least a year after the stent is implanted. Currently the manufacturer of the Cypher stent only recommends three months of blood thinner and the manufacturer of the Taxus stent only recommends six months. Many doctors believe that anti-clotting medications, such as Plavix, need to be taken for even longer than one year. However, there are serious concerns regarding Plavix side effects which could be increased with extended use of the blood thinner.
Drug coated stent lawsuits are currently being investigated and reviewed for individuals who have suffered blood clots, reclogging of the artery, heart attacks or death. The manufacturers have failed to adequately warn about the drug coated stent dangers.
If you, a friend or family member believe you may have a case, request a free consultation and claim evaluation.







