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Drug-eluting stents update: FDA Patient Safety News

Harvey Kirk

In the March 2007 “FDA Patient Safety News Show”, concerns about drug eluting stents were discussed.  The FDA show is designed for health professions to provide safety information and news alerts. The portion of the show discussing concerns about drug coated stents was posted on the FDA website today.

>>VIDEO: FDA Patient Safety Alert: Drug Eluding Stents

In December 2006, an FDA advisory panel was convened to discuss medicated stent concerns which have existed among cardiologists since recent studies indicated the small wire devices are associated with an increased risk of blood clots when compared with older bare metal stents.

>>INFORMATION: Drug eluting stent concerns

The FDA show indicates that the Cypher stent and Taxus stent were approved because they may reduce the rate of re-clogging of the arteries, known as vessel restenosis.  However, problems caused by the medicated coating actually increases the risk of potentially fatal blood clots, which many believe is a much greater concern than restenosis.

The increased risk of blood clots in drug eluding stints could continue for several years after the device is placed in the artery.  Therefore, the FDA panel emphasized the importance of patients remaining on antiplatelet medications for at least twelve months after the surgery, despite the fact that prior recommendations by the stent makers was for patients to remain on three to six months of anti-clotting therapy.

For many patients who have received the devices, their biggest concern about drug coated stents is why the manufacturers failed to warn of the dangers associated with their product.  Had the problems been disclosed, physicians may have recommended alternate treatment such as bypass surgery, medication or bare metal stents.

Now that safety concerns are known, experts are stressing that physicians should only implant the stints for clinically stable patients and in patients who are able to stay on antiplatelet therapy for a long time.  Before the safety concerns surrounding drug coated stents were disclosed, the vast majority of all stents implanted were “off-label”, for more complex conditions, which increases the risk of blood clots further.  In addition, many patients who received the stents were not properly educated about the importance of continuing long-term antiplatelet therapy, which could reduce the risk of potentially fatal injuries.


Individuals who received a medicated stent and suffered a blood clot, reclogging of the artery or heart attack, may be entitled to financial compensation as a result of the manufacturer’s failure to warn of the stent problems.  The drug eluting stent lawyers at Saiontz & Kirk, P.A. represent individuals nationwide who have been injured.  To protect your family’s rights, request a free stent lawsuit claim evaluation.

Posted in Stents | 12 Comments »

12 Comments Add Your Comments

  1. G. CARLTON SEVY says:

    I had two medicated stents installed 11/22/06 and was never advised or given full disclosure of the existing problem of medicated stents. Since the procedure I have had a progressive expanding rash and itch that has spread over my entire body. All prescribed medications have just exacerbated the problem with more debilitating side effects.

    I am unable to rest or sleep well with the rash and itch, and it keeps getting worse.

    In this so-called “WONDERFUL SCIENTIFIC AGE”, does not any one know how to treat CAUSE, instead of a Band-Aid to treat EFFECT?

  2. my mom had that stint put in in November 2006, she has been complaining about a cronic cough and her legs hurt….the dr. said its from her medication, has there been anyone else with similar problems.

  3. On Jan. 18,2007 I had 2 stints put in. One was a drug eluding stint and the other was a bare metal. I have been having muscle cramps in my calves for the last 2 weeks. I don’t know if this is a side effect of the stints or the Plavix that I take. My calves have knots in them and I get Charley horses. I have had Charley horses before, but not on a constant basis. Any ideas would be appreciated.

  4. Daniel C. Gengenbach says:

    Dan says:

    On July 17th 2005 I underwent a procedure that installed three coated stents into my heart. Three days later I broke out in a rash on my arms. Crater-like skin eruptions that itch terribly. Since then the rash has spread over my body. I have seen a dermotologist, who said it was a contact dermititis. I was with him for eight months as things got progressively worse. I saw a infectious disease guy who mentioned the stents but could not give me any further information. I have seen a gastrointenologist, who said it was Celliacts disease and he put me on a Gluten free diet for the last four months. The rash got worse and spread over the rest of my body. Finally I borrowed my son’s computer and got on the internet. I need the truth and I believe I may get it and some medical relief from this web site.

  5. My dad had a stent put in in nov of 2004 and since then he has had numerous muscle cramps in his calves. Sometimes they get so bad they wake him up. My dad has also suffered from many headaches since the placement of the stent. He has never had a rash. My dad used to be on Plavix but has not been on it for about a year and he still gets just as many leg cramps.


    I Just had 2 medicated stints put in on 07/07/2007. today is 071707, and hae cramps in legs and shoulders. Now I am really scared

  7. Ray Dempsey says:

    I had a cypher stent put in 3 years ago after my heart attack,First year I had itching under my arms and my head, suffered severe chest heaviness,Cramping in my legs,They Recathedorized me 3 times to see why i had such painafter the cypher stent was in.I was on plavix for a year and then baby asprin a year and now on 325 asprin,coreg,gemfibrozil,lisnopril simvastatin,I was nevered offered an option,It was put in and then given a card after the procedure to carry,I was only 48 years old at the time,I still suffer every day,I wish I would have had a choice, Ray

  8. bill morris says:

    In responce to sandy
    Ypur mom is having problems simular to several in this group me included. To this day I have not gotten a complete answer for my joint and muscle pain. Wish your mom the best.
    In response to dan
    Dan I understand what you are going through to some degree. I have the rash periodically myself but it comes and goea in my case. I have constant joint and muscle pain. My doctors, all three of them want me on disability. I used to work 40-80 hours a week before my 2 heartattacks and now I can only do limited tasks for a short period of time about 10-15 minutes and I get short of breath and have to stop. You and sandy both neet to join the heartattack group in yahoo groups. It can help you and her both. Wishing all the best. Bill

  9. I was given an angioplasty in July of 2006 and was found to have two major blockages in a right artery. The following morning I was ambulanced to another town to have two medicated stents in this artery. The only question I was asked by the attending physician before an immediate surgery was “are you good at taking, medicine. Since the implantation of these medicated stents, I have been brought to the Emergency Room approximately 25 times since the 2 stent s were implanted in my right artery.

    I am thoroughly disgusted with the articles that I have read from the FDA about medicated stents, and as a matter of fact, even cardiologists are now saying that they were too quick to engage in this new “scientific method” before the FDA had any concrete evidence in long-term studies that proved no harm would effect the patient because of these stents. I know people that had the bare metal stent implanted and never have a problem.

    I also have pain in my legs every single night to the point where it wakes me up. I am astonished at the long list of medications that I have to stay on. These mdicated stents were suppose to bring back a normal life style instead I have landed up on Social Security disability. I am 57 years old. I also have to carry Nitro-Quik with me wherever I go because I never know when I am going to have an attack of severe heaviness or tightness in my chest.

    I just pray every day and thank the Lord for every day he gives me.

  10. Hello all I am 73 years old and female. I was given a drug eluted stent and was’nt even told why it was neccessary! My cardiologist of 20 years had already given me 2 angioplasties. This stent was placed in my main artery and all he said was without it i could have a heart attack. I have been on Plavix for 2 years and have to take it for the rest of my life. I also have a pepcid ulcer and I hear that these two dont match, right? I am so upset with the entire situation. I to have muscle pain and headaches. I can barely walk now without feeling pain and no one seems to care or have answers. iIcontinue to have irregular heart beats and am still constantly calling my doctor at 2 or 3am in the morning with discomfort. at his request just take another beta blocker and go to sleep. What? God give us all the strength to live and enjoy everyday we are given. I pray for you all.

  11. Rajasekar says:

    It is about 1year 6months since three stents were placed in right artery in a hospital @ Chennai.With the Grace of God,I am doing well and taking medicines like Ecosprin,Seruvin&tonact.Forget that you are on stent.

  12. i am back again wit the same problems but they are getting worse.the itching is getting worse & also the coughing is getting worse, it is keeping me up at night when i cough stuff come up.if i was told of the possible adverse side effects i would had never had stents put in.i am still having breathing & chest pain. i wish i have had heart surgery. i stay in fear most of the time, no one understand if they have never had stents. i think that each patient should should had been told the truth about what could had happen. my doctor which i think is a very good doctor,might not have known all the side effects. i think the company that made these stents should be held responsible. i don’t know if you know how it feel when you try to breath & only get little puff of air & feel as if it is your last breath.

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