Plavix Lawsuit: Black Box Warning Indicates Drug Ineffective in Some Patients

Harvey Kirk

By Harvey Kirk
Posted March 15, 2010


[alert type=”general” accent_color=”” background_color=”” border_size=”1px” icon=”fa-asterisk” box_shadow=”yes” animation_type=”0″ animation_direction=”down” animation_speed=”0.1″ class=”” id=””]UPDATE: Saiontz & Kirk, P.A. is no longer accepting new Plavix cases.
This archived post is for informational purposes.[/alert]

The FDA has announced a “black box” Plavix warning, indicating that the anti-clotting medication may be ineffective in some patients with a genetic variation. This could cause an individual at risk for a heart attack, stroke, angina or cardiovascular death to suffer a serious and potentially life-threatening injury.

The Plavix lawyers at Saiontz & Kirk, P.A. have been investigating potential cases against Sanofi-Aventis and Bristol-Myer Squibb for failing to warn about the dangerous side effects of Plavix for over three years, and potential Plavix lawsuits are continuing to be evaluated for individuals who suffered a:

The new Plavix black box warning is the strongest type of cautionary statement that can be placed on a prescription medication. The FDA mandated the warning to ensure that doctors and consumers are aware that Plavix may be ineffective in users who are poor metabolizers of the drug, which could affect up to 14% of the population.

There is a genetic test available that can identify which potential Plavix users have reduced functioning of the CYP2C19 liver enzyme, making them poor Plavix metabolizers. If the drug makers had properly warned about this risk earlier, it could have prevented many users from suffering heart attacks, strokes and other cardiovascular injuries. It also could have allowed users to avoid unnecessary exposure to Plavix side effects.


If you, a friend or family member have taken Plavix and suffered a heart attack, stroke, internal bleeding, ulcers, TTP or death, request a free consultation and claim evaluation to determine if compensation may be available through a Plavix lawsuit. All cases are reviewed and evaluated on a contingency fee basis, which means that there are no fees or expenses unless a recovery is obtained.


25 Comments • Add Your Comments

  • V. Knight says:

    A black box warning? How bad can it get with prescription medication. I have ulcers and high cholesterol and I had hepatitis. I can tell within 1 hour of swallowing a Plavix that it is in my body. The pill creates a horrifc state of depression for me so bad that I can hardly stand to be around anyone. I want to cry all of the time. The physical effects are back pain and a host of other side effects. It would be prudent that our government spend more time checking out these drugs that are “safe” – we already believe nobody who is connected with prescriptions.

    Posted on March 15, 2010 at 11:15 am

  • Jane says:

    I got ttp in 2007 from plavix

    Posted on March 24, 2010 at 10:13 pm

  • larry says:

    I also got ttp in 2007 after taking plavix for 2 weeks , its a very dangerous drug , The FDA needs to really investigate all new drugs that are going to be put out on the market , as a young man growing up I dont remember hearing anything about bad medication , but in the last 10 years or so, thats all you hear about with all these new drugs , most of them have bad side effects

    Posted on March 31, 2010 at 9:26 pm

  • Waite says:

    I got TTP in 2003. I have had over 5 strokes ( 2 major, 3 minor strokes). I am on disability now. I spend every month having my blood checked to see if my platlets are too low. The TTP is a lifetime altering disease. How can you alert the way your body makes blood. This is more of a criminal offense. I think the drug manufacures should be in jail as well. The drug companies should be held accountable for their greed. The are making a lot of money on my suffering. I know justice will be served if they pay all of the families who are suffering for the rest of their life. It\’s time to pay.

    Posted on April 10, 2010 at 11:18 am

  • ronald says:

    t ake Plavix [ 7-9 yrs} Have had a heart attack,a cerebellar strtoke, have had AAA sugery with lots of blood loss, have lots of ugly large red spoys over my body. HELP

    Posted on April 11, 2010 at 1:45 pm

  • mary says:

    My husband died of TTP 7/07. 40 days of plasma pheresis and dialysis was not enough to save him. All the summaries from specialist state TTP. This is a matter of medical record. One md completed a summary to other medical communiites that Plavix and TTp was the cause of death.

    Posted on April 27, 2010 at 9:08 am

  • Gwen says:

    My husband has been taking Plavix for two months and he hurts all over and has no energy and is always tired. The Dr. said she couldn’t give him anything other than Plavix. He had two strokes prior to taking Plavix. He is 86 and will be 87 in November. I don’t want to lose him, can you give me any advice?

    Posted on June 7, 2010 at 4:03 pm

  • W. Waite says:

    Gwen -please have your husban see a hemotologigist immdiately- if your husbanddnd huts all over and have red spots, have tea color ueine- this is signs of TTP- .

    Posted on July 1, 2010 at 4:57 pm

  • Debbie says:

    My father was taking Plavix for a couple of years, was diagnoised with a AAA which killed him 10 months later. Dad was never taken off Plavix after the dx. He was taking Plavix at least a year after his AAA dx. Could this have exasterbated his death? (he was never taken off cumadin as well). Venting,…I miss my dad!

    Posted on October 13, 2010 at 6:31 pm

  • jun says:

    I had a heart attack in 2004. Since then my doctor prescribe me to take plavix medication. On 2008 in September I had my second heart attack and according to my doctor my arteries full of blood clot. Again the plavix was prescribe and combined with aspirin. On October 8, 2010, I had a muscle pain, urinating problem (in pain every time I go to the restroom) gas bloated and constipated. I went to see my doctor and he conducted a series of blood test regarding internal organ. He found out that I have irregular count of my liver. He sent me to have ultra sound to check my liver and gal bladder on October 18, 2010. To date, I haven’t heard from my doctor yet regarding the ultra sound test. My doctor prescribes an antibiotic medicine that makes me feel better in urinating.

    Posted on November 8, 2010 at 8:54 pm

  • virginia says:

    i am having more problems with plavix & stents, they are causing problems with chest pain, breathing problems & my hands are numb most of the time & my hands & arms hurt so bad they keep me up at night.

    Posted on November 29, 2010 at 1:08 pm

  • Vicky says:

    I am having more problems with plavix & stents, they are causing problems with chest pain, breathing problems & my hands are numb most of the time & my hands & arms hurt so bad they keep me up at night. I no engery .

    I thought I was going crazy .. I have the same problem as the person above.

    Posted on March 9, 2011 at 2:02 pm

  • rita says:

    I was on Plavix + baby asprin since feb 2001 after my 1st heart attack until the last heart attack sept 2010 was told I would be on Plavix the rest of my life. The Dr took me off after running some test when I was in hospital Sept 2010 for heart attack and said Plavix was’nt working for me. WTH after 9yrs stents-balloned out-over 13+ frigging heart attacks-1st open heart in 2004 + another Dec 2010 and several trips to hospital and NOW after they have sold Billions of this shit THEY HAVE A TEST and tell me it’s not for me!!! I have asked Dr over and over the past 9yrs what was causing me to have so many heart attacks and all I got was just bad luck.LOOKS LIKE MY BAD LUCK WAS PLAVIX.

    Posted on April 15, 2011 at 6:16 pm

  • bobby says:

    I to am on plavix and in october of last year i had to have triple bypass surgury I was on plavix the whole time i still have chest pain and pain in my arms bck neck shoulders Istill take plavix every day i am afraid not to take it but acording to my doctors i should not have had a heartattack while takeing plavix.but yet i have scars and holes in my chest an stomach to prove otherwise

    Posted on August 7, 2011 at 10:31 pm

  • Dan says:

    Folks, if you’re currently taking Plavix ask your doctor for a genetic test for the 2C19 enzyme. It determines if you can take Plavix, and if so, what dosage. If your doctor has no clue about the test (despite the black box warning and Plavix commericals recommeding it now on TV), tell them it can be ordered from any of the following labs: Genelex, Labcorp, Quest.

    Posted on August 29, 2011 at 5:07 pm

  • Mark says:

    I had my 1st. heart stent put in sometime in 2005 and my second stent put in at the end of 2009 . I am now 51 years old and have a burning in my stomach all the time. I eat tums like they are candy to try to get some relieve from the burn in my stomach.I have been haveing mild to severe chest pain a lot. I need to know a lot more information about Plavix.I was put on Plavix in 2005 after the first stent and was told by the dr. I would have to take Plavix the rest of my life.

    Posted on September 29, 2011 at 3:28 pm

  • jack says:

    took plavix last three months of 2005 17jan.2006 had my left amputated above the knee whole lotta good plavix did for me

    Posted on October 2, 2011 at 7:08 am

  • DONNA says:

    I was put on plavix after a heart attack and 2 stents was put in. about 5 months ago i started having red knots come up on me for no reason they have fever in them most of the time, as of right now my left wrist started swelling up for no reason i did nothing to make it swell up sometimes i have slight shortness of breath ,i still smoke but it just started about a month ago. can these symptoms be caused by plavix? Can someone please let me know something. what do i need to do.

    Posted on November 14, 2011 at 1:05 pm

  • Norbert says:

    I was put on PLAVIX 75mg tabs Feb 2009 and have been on 1xd ever since. This was immediately after tri by pass surgery. I am 76 years of age. I was in good shape immediately after my op but have steadily been going down hill ever since. Syyptoms include weakness in lege from my hips to my toe, extreme shortness of breath,malaise. I also was prescribed 81 mg aspirin. Prior to this op I have had a heart attack and a stroke.I do not know why I feel this way. Maybe just ‘old age’……..

    Posted on November 24, 2011 at 11:24 am

  • Diane says:

    I had a massive heart attack 9-2008, & 3 stents placed i was very active & only 45, since then i was put on plavix and aspirin for life my face & chest flush with redness sometimes on arms , i have no energy im fatigue all the time have red lines on chest, my breathing is heavier i get arm & leg pains adominal pains & hotness in legs also been getting ringing & pains in ear and seen a emt he tested my hearing and told me it is a vascular problem i constantly get hemmorages in my eyes.

    Posted on November 25, 2011 at 5:14 pm

  • Jerry says:

    I took plavix for over a month and developed a severe problem with it to the point I ended up in the Hospital. My body sweeled up and I had 2 additional TIA’s. 2 years after that I was found to have a large brain anyersum that required 2 surgeries to repair. I spent 10 days in the hospital.

    Posted on November 25, 2011 at 6:03 pm

  • Wayne says:

    I was put into the hospital inJune 2007. The dr.gave me a dose of about 10to12 plavix,s befor the stints x3 were put in. The next day about midday I passed away twice in 30 minutes the last time I came to I had a nurse on my chest.hollaring at me.I aked her what she was doing there and she just laughedf and gave a sigh of relife, as my wife did the same.I have had the stints about six years now , and my hands are always numb especialy in my fingers and i have a hard time picking up small things,I also have some light chest pain from time to time and I have noticed that I have started to haveing trouble remembering things.I saw my dr. associate on 12/5/11 and she said that I was ok.I will see my other dr.(regular dr) on the 15th of this month and I will find out abouthe test 2c19ezyine test.If this is the result of this drug I am going to join the suite. Wayne

    Posted on December 8, 2011 at 9:28 pm

  • Shan says:

    My mom was on Plavix for several years. She died 9.08 of renal failure. A major contributing factor was ITP. (Idopathic Thrombocytopenia Purpora) Meaning they had no idea why her platlets were low. She needed orthopedic surgery, when she was admitted to the hospital blood test showed her platelets much too low for surgery. The doctors tried for over three weeks to get her count up. Nothing worked. They gave up, her kidney got worse, she died.

    Posted on January 1, 2012 at 11:56 pm

  • dyanne says:

    I wonder how many of you could have benefited from the pharmacogenetic test available which would show your Dr. what kind of liver metabolizer you are (drug may be ineffective to toxic) and if you are at higher risk for clotting and thrombophilia. The black box warning on the plavix label lets practitioners and patients know some people respond differently due to their genetic makeup and there is a test available to help guide treatment decisions. Why aren’t they ordering it?

    Posted on November 19, 2013 at 5:54 pm

  • David says:

    I have been on Effient and then Plavix for the past month. The pain I have in both shoulders is almost unbearable! I cannot sleep on either side and I always have due to lower back pain. I cannot yawn normally with a stretch of my arms or I nearly fall to the floor in pain!

    Posted on December 16, 2014 at 6:36 pm

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