PLAVIX Safety

PLAVIX Living Proof Means a Well-Established Safety Profile

PLAVIX has a well-established safety profile in a broad range of patients.

PLAVIX Safety studied in a broad range of patients (table)

  • Studied in 4 large clinical trials involving more than 81,000 patients
  • Supported by a decade of real-world clinical experience 24
  • More than 70 million prescriptions worldwide 24

PLAVIX is contraindicated in patients with active pathologic bleeding such as peptic ulcer or intracranial hemorrhage. PLAVIX should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or coadministration with NSAIDs or warfarin. 13

In clinical trials, the most common clinically important side effects were pruritus, purpura, diarrhea, and rash; infrequent events included intracranial hemorrhage (0.4%) and severe neutropenia (0.05%). 17

For more information on safety in each trial, use the links below or scroll down the page:

PLAVIX Monotherapy
CAPRIE Trial

PLAVIX with Aspirin
CURE Trial
COMMIT Trial
CLARITY Trial

PLAVIX Monotherapy

CAPRIE (Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events) Trial

In the CAPRIE trial, safety and tolerability were similar to aspirin

PLAVIX vs. Aspirin for bleeding events in CAPRIE trial in recent MI, recent ischemic stroke, or established PAD

Adverse events occurring in ≥2.5% of PLAVIX patients in CAPRIE 24

PLAVIX vs. Aspirin for Body System Events in CAPRIE Trial in recent MI, recent Ischemic stroke, or established PAD

As part of the worldwide postmarketing experience with PLAVIX, there have been cases of reported TTP, some with fatal outcome. TTP has been reported rarely following use of PLAVIX, sometimes after a short exposure (<2 weeks). TTP is a serious condition that can be fatal and requires urgent treatment including plasmapheresis (plasma exchange). 24

No additional clinically relevant events to those observed in CAPRIE with a frequency ≥2.5% have been reported during the CURE and CLARITY controlled studies. COMMIT collected only limited safety data. 24

Other adverse experiences of potential importance occurring in <2.5% of patients receiving PLAVIX in the controlled clinical trials have been reported. In general, the incidence of these events was similar to that in patients receiving aspirin (in CAPRIE) or placebo + aspirin (in other clinical trials). 24

PLAVIX with Aspirin

CURE (Clopidogrel in Unstable angina to prevent Recurrent Events) Trial

In the CURE Trial of 12,562 UA/NSTEMI Patients, the Rates of Major and Minor Bleeding Were Higher in Patients Treated With PLAVIX + Aspirin Compared With Placebo + Aspirin 24

Incidence of Bleeding for PLAVIX + Aspirin vs. Placebo + Aspirin in CURE Trial in UA/NSTEMI(table)

For more information on safety in the CURE trial, click here.

If a patient is to undergo elective surgery and an antiplatelet effect is not desired, PLAVIX should be discontinued 5 days prior to surgery.

COMMIT (Clopidogrel and Metoprolol in Myocardial Infarction Trial) Trial

In the COMMIT Trial of 45,852 STEMI Patients, the Overall Rate of Non-Cerebral Major Bleeding or Cerebral Bleeding Was Low and Similar in Both Groups 24

Incidence of Bleeding for PLAVIX + Aspirin vs. Placebo + Aspirin in COMMIT Trial in STEMI (table)

  • In the COMMIT Trial, 11,934 Patients Were ≥70 Years Old 24
  • The relative rate of major non-cerebral or cerebral bleeding was independent of age (event rates by age for PLAVIX + asprin vs placebo + asprin: <60=0.3% vs 0.4%; ≥60 to <70=0.7% vs 0.6%; ≥70=0.8% vs 0.7%) 24

For more information on safety in the COMMIT trial, click here.

CLARITY (Clopidogrel as Adjunctive Reperfusion Therapy) Trial

In the CLARITY Trial of 3,491 STEMI Patients, the Incidence of Fatal Bleeding and Intracranial Hemorrhage Was Low and Similar in Both Groups 24

Incidence of Bleeding for PLAVIX + Aspirin vs. Placebo + Aspirin in CLARITY Trial in STEMI (table)

  • Major bleeding rates were consistent across subgroups and type of fibrinolytic or heparin therapy 24

For more information on safety in the CLARITY trial, click here.
Indications
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Use PLAVIX plus aspirin for patients with non–ST–segment elevation acute coronary syndrome (UA/non–Q–wave MI), including patients to be managed medically and those to be managed with percutaneous coronary intervention (with or without stent) or CABG, to decrease the rate of a combined end point of CV death, MI, or stroke as well as the rate of a combined end point of CV death, MI, stroke, or refractory ischemia.

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Use PLAVIX plus aspirin for patients with ST–segment elevation acute myocardial infarction to reduce the rate of death from any cause and the rate of a combined end point of death, reinfarction, or stroke. This benefit is not known to pertain to patients who receive primary angioplasty.

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Use PLAVIX alone for patients with a history of recent stroke, recent MI, or established PAD to reduce the rate of a combined end point of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
Important Risk Information 18
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PLAVIX is contraindicated in patients with active pathologic bleeding such as peptic ulcer or intracranial hemorrhage. PLAVIX should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or coadministration with NSAIDs or warfarin. (See CONTRAINDICATIONS and PRECAUTIONS.*)

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The rates of major and minor bleeding were higher in patients treated with PLAVIX plus aspirin compared with placebo
plus aspirin in clinical trials. (See ADVERSE REACTIONS.*)

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As part of the worldwide post–marketing experience with PLAVIX, there have been cases of reported thrombotic thrombocytopenic purpura (TTP), some with fatal outcome. TTP has been reported rarely following use of PLAVIX, sometimes after a short exposure (<2 weeks). TTP is a serious condition that can be fatal and requires urgent treatment including plasmapheresis (plasma exchange). (See WARNINGS.*)

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In clinical trials, the most common clinically important side effects were pruritus, purpura, diarrhea, and rash; infrequent events included intracranial hemorrhage (0.4%) and severe neutropenia (0.05%). (See ADVERSE REACTIONS.*)