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judeet47

My husband has been taking Plavix for 6 years and has recently been diagnosed with MDS Leukemia.  I feel there may be a connection.  Anyone else find this may be happening to them?
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Avatar universal
This is definitely a HARD judgement call about what to do about the Plavix.  Is he on the Plavix because of a history of blood clots or heart/vascular problems?  You can always the second opinion physician if Aspirin therapy is an option in lieu of the Plavix.  

As a nurse, I have given out so much Plavix and I cannot recall anyone experiencing MDS after Plavix therapy; that is my experience.  I do know MDS is highly linked to benzene, xylene, radiation, certain chemotherapies, agent orange exposures and genetic mutation.  

MDS has a 30-40% chance of converting to AML.
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Avatar universal
Thanks for all the information.  I am trying to gather as much info as I can for our appt. on Monday at Roswell Park Cancer Inst. for a 2nd opinion.  I know it's a long shot, but I just feel as though all this started because of the Plavix.  

Thanks again.  It means a lot to know that there are people out there who are caring enough to take the time to research this.

Judeet47
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Avatar universal
They are calling it PreLeukemia.  I feel that if he is being treated for this syndrome that continuing to take the Plavix would be counterproductive.  So far the hematologist/oncologist that is treating him does'nt seem to think it's a factor.  We have an appt. on Mon. at Roswell Park Cancer Inst. for a 2nd opinion.  I'm trying to gather some information because I just feel like the Plavix may have been at the root of this.  I know it's rare, but it's not impossible.  I know it can't be reversed just by not taking the Plavix, but it can't be helping either.  From what I have read, Aspirin can accomplish the same results without some of the side effects that Plavix has.  
Thank you for your response to my question.  I really appreciate it.  I am trying to educate myself so that I can do my best to help my husband through this.
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Avatar universal
MDS is NOT Leukemia, but a precursor to Leukemia.  Which does your husband have?  

The link to the Plavix and this abnormal syndrome and Leukemia is there but the occurrence is rare.  
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Avatar universal
See bottom of paragraph stating there have been rare cases of leukemia tied to Plavix.

Plavix
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Plavix:

Easy bruising; minor bleeding.

Seek medical attention right away if any of these SEVERE side effects occur when using Plavix:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; bleeding in the eye; change in vision; change in the amount of urine produced; chest pain; dark or bloody urine; fever or sore throat; loss of appetite; pale skin; seizures; severe, persistent headache; speech problems; unexplained weight loss; unusual bruising or bleeding; unusual or severe bleeding (eg, excessive bleeding from cuts, increased menstrual bleeding, unexplained vaginal bleeding, unusual bleeding from the gums when brushing); unusual tiredness or weakness; yellowing of the skin or eyes.


Top

Plavix Side Effects - for the Professional
Plavix
The following serious adverse reactions are discussed below and elsewhere in the labeling:

Bleeding [see Warnings and Precautions (5.2)]
Thrombotic thrombocytopenic purpura [see Warnings and Precautions (5.5)]
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions and durations of follow up, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Plavix has been evaluated for safety in more than 54,000 patients, including over 21,000 patients treated for 1 year or more. The clinically important adverse reactions observed in trials comparing Plavix plus aspirin to placebo plus aspirin and trials comparing Plavix alone to aspirin alone are discussed below.

Bleeding

CURE

In CURE, Plavix use with aspirin was associated with an increase in major bleeding (primarily gastrointestinal and at puncture sites) compared to placebo with aspirin. The incidence of intracranial hemorrhage (0.1%) and fatal bleeding (0.2%) were the same in both groups. Other bleeding events that were reported more frequently in the clopidogrel group were epistaxis, hematuria, and bruise.

The overall incidence of bleeding is described in Table 1.

Table 1: CURE Incidence of Bleeding Complications (% patients) Event Plavix
(+ aspirin)* Placebo
(+ aspirin)* p-value
(n=6259) (n=6303)  
*
Other standard therapies were used as appropriate.

Life-threatening and other major bleeding.

Major bleeding event rate for Plavix + aspirin was dose-dependent on aspirin: 200 mg = 4.9%
Major bleeding event rates for Plavix + aspirin by age were: <65 years = 2.5%, ≥65 to <75 years = 4.1%, ≥75 years = 5.9%
§
Major bleeding event rate for placebo + aspirin was dose-dependent on aspirin: 200 mg = 4.0%
Major bleeding event rates for placebo + aspirin by age were: <65 years = 2.1%, ≥65 to <75 years = 3.1%, ≥75 years = 3.6%

Led to interruption of study medication.  
Major bleeding † 3.7 ‡ 2.7 § 0.001
  Life-threatening bleeding 2.2 1.8 0.13
    Fatal 0.2 0.2  
    5 g/dL hemoglobin drop 0.9 0.9  
    Requiring surgical intervention 0.7 0.7  
    Hemorrhagic strokes 0.1 0.1  
    Requiring inotropes 0.5 0.5  
    Requiring transfusion (≥4 units) 1.2 1.0  
Other major bleeding 1.6 1.0 0.005
    Significantly disabling 0.4 0.3  
    Intraocular bleeding with significant loss of vision 0.05 0.03  
    Requiring 2–3 units of blood 1.3 0.9  
Minor bleeding ¶ 5.1 2.4 < 0.001

Ninety-two percent (92%) of the patients in the CURE study received heparin or low molecular weight heparin (LMWH), and the rate of bleeding in these patients was similar to the overall results.

COMMIT

In COMMIT, similar rates of major bleeding were observed in the Plavix and placebo groups, both of which also received aspirin.

Table 2: Incidence of Bleeding Events in COMMIT (% patients) Type of bleeding Plavix
(+ aspirin)
(n=22961) Placebo
(+ aspirin)
(n=22891) p-value
*
Major bleeds were cerebral bleeds or non-cerebral bleeds thought to have caused death or that required transfusion.

The relative rate of major noncerebral or cerebral bleeding was independent of age. Event rates for Plavix + aspirin by age were: <60 years = 0.3%, ≥60 to <70 years = 0.7%, ≥70 years = 0.8%. Event rates for placebo + aspirin by age were: <60 years = 0.4%, ≥60 to <70 years = 0.6%, ≥70 years = 0.7%.  
Major* noncerebral or cerebral bleeding† 0.6 0.5 0.59
  Major noncerebral 0.4 0.3 0.48
    Fatal 0.2 0.2 0.90
Hemorrhagic stroke 0.2 0.2 0.91
  Fatal 0.2 0.2 0.81
Other noncerebral bleeding (non-major) 3.6 3.1 0.005
Any noncerebral bleeding 3.9 3.4 0.004

CAPRIE (Plavix vs. Aspirin)

In CAPRIE, gastrointestinal hemorrhage occurred at a rate of 2.0% in those taking Plavix vs. 2.7% in those taking aspirin; bleeding requiring hospitalization occurred in 0.7% and 1.1%, respectively. The incidence of intracranial hemorrhage was 0.4% for Plavix compared to 0.5% for aspirin.

Other bleeding events that were reported more frequently in the Plavix group were epistaxis and hematoma.

Other Adverse Events

In CURE and CHARISMA, which compared Plavix plus aspirin to aspirin alone, there was no difference in the rate of adverse events (other than bleeding) between Plavix and placebo.

In CAPRIE, which compared Plavix to aspirin, pruritus was more frequently reported in those taking Plavix. No other difference in the rate of adverse events (other than bleeding) was reported.

Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Plavix. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura (TTP)
Gastrointestinal disorders: Gastrointestinal and retroperitoneal hemorrhage with fatal outcome, colitis (including ulcerative or lymphocytic colitis), pancreatitis, stomatitis
General disorders and administration site condition: Fever, hemorrhage of operative wound
Hepato-biliary disorders: Acute liver failure, hepatitis (non-infectious), abnormal liver function test
Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness
Musculoskeletal, connective tissue and bone disorders: Musculoskeletal bleeding, myalgia, arthralgia, arthritis
Nervous system disorders: Taste disorders, fatal intracranial bleeding
Eye disorders: Eye (conjunctival, ocular, retinal) bleeding
Psychiatric disorders: Confusion, hallucinations
Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, respiratory tract bleeding
Renal and urinary disorders: Glomerulopathy, increased creatinine levels
Skin and subcutaneous tissue disorders: Maculopapular or erythematous rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, erythema multiforme, skin bleeding, lichen planus
Vascular disorders: Vasculitis, hypotension

Rare incidences of granulocytopenia, leukemia, leukopenia, and a decrease in neutrophils have also been reported.


Read more: http://www.drugs.com/sfx/plavix-side-effects.html#ixzz10NkJnOqG


I would say after reading this......it is VERY possible there is a connection to Plavix and his leukemia.

Hope this helps.
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