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Plavix

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Plavix

Plavix

Plavix Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Plavix (clopidogrel bisulfate) is a thienopyridine class of drug that inhibits platelet aggregation and thus inhibits aspects of blood clotting. Plavix is available in the generic form termed clopidogrel bisulfate. This drug is used to treat patients with acute coronary syndrome, myocardial infarction (MI), peripheral vascular disease and some stroke (ischemic type) patients. The most common side effects are: increased bleeding, nose bleeds, headaches, and bruising.

Plavix is supplied as 75 and 300 mg tablets. For acute coronary syndrome with a non-ST elevation MI, the initial recommended dose is 300 mg, followed by a 75 mg dose per day; for ST elevation MIs, the initial and continuing dose is 75 mg per day. The recommended dose is 75 mg per day for patient with a history of MI, stroke, or peripheral vascular disease. Many doctors may choose to add an aspirin per day along with the Plavix dose in both non-ST elevation and ST elevation MIs as well as to stroke and peripheral vascular disease patients. Patients taking omeprazole have reduced Plavix efficacy due to CYP2C19 enzyme inhibition. (Some patients genetically also have this problem). Plavix should be used during pregnancy only if clearly needed. Most clinicians advise lactating females not to use Plavix, but nursing mothers should discuss the use of this drug with their OB-GYN physicians.

Our Plavix Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Plavix in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using clopidogrel and call your doctor at once if you have any of these serious side effects:

  • nosebleed or other bleeding that will not stop;
  • bloody or tarry stools, blood in your urine;
  • coughing up blood or vomit that looks like coffee grounds;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • pale skin, weakness, fever, or jaundice (yellowing of the skin or eyes); or
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.

Less serious side effects may include itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Plavix (Clopidogrel Bisulfate) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Plavix FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed below and elsewhere in the labeling:

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 (see Table 1). 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)*
(n=6259)
Placebo (+ aspirin)*
(n=6303)
Major bleeding † 3.7 ‡ 2.7 §
  Life-threatening bleeding 2.2 1.8
    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
  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
* 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: < 100 mg = 2.6%; 100-200 mg = 3.5%; > 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: < 100 mg = 2.0%; 100-200 mg = 2.3%; > 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.

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 (see Table 2).

Table 2: Incidence of Bleeding Events in COMMIT (% patients)

Type of bleeding Plavix (+ aspirin)
(n=22961)
Placebo (+ aspirin)
(n=22891)
p-value
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
* 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%.

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), acquired hemophilia A
  • Eye disorders: Eye (conjunctival, ocular, retinal) bleeding
  • Gastrointestinal disorders: Gastrointestinal and retroperitoneal hemorrhage with fatal outcome, colitis (including ulcerative or lymphocytic colitis), pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea
  • 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, headache
  • Psychiatric disorders: Confusion, hallucinations
  • Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, respiratory tract bleeding, eosinophilic pneumonia
  • Renal and urinary disorders: Increased creatinine levels
  • Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), erythema multiforme, skin bleeding, lichen planus, generalized pruritus
  • Vascular disorders: Vasculitis, hypotension

Read the entire FDA prescribing information for Plavix (Clopidogrel Bisulfate) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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