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Plavix Side Effects

SIDE EFFECTS

PLAVIX has been evaluated for safety in more than 11,300 patients, including over 7,000 patients treated for 1 year or more. The overall tolerability of PLAVIX was similar to that of aspirin regardless of age, gender and race, with an approximately equal incidence (13%) of patients withdrawing from treatment because of adverse reactions. The clinically important adverse events observed in CAPRIE are discussed below.

Hemorrhagic: In patients receiving PLAVIX in CAPRIE, gastrointestinal hemorrhage occurred at a rate of 2.0%, and required hospitalization in 0.7%. In patients receiving aspirin, the corresponding rates were 2.7% and 1.1%, respectively. The incidence of intracranial hemorrhage was 0.4% for PLAVIX compared to 0.5% for aspirin.

Neutropenia/ agranulocytosis: Ticlopidine, a drug chemically similar to PLAVIX, is associated with a 0.8% rate of severe neutropenia (less than 450 neutrophils/ mL). Patients in CAPRIE (see Clinical Trials) were intensively monitored for neutropenia. Severe neutropenia was observed in six patients, four on PLAVIX and two on aspirin. Two of the 9599 patients who received PLAVIX and none of the 9586 patients who received aspirin had neutrophil counts of zero.

One of the four PLAVIX patients was receiving cytotoxic chemotherapy, and another recovered and returned to the trial after only temporarily interrupting treatment with PLAVIX. Although the risk of myelotoxicity with PLAVIX thus appears to be quite low, this possibility should be considered when a patient receiving PLAVIX demonstrates fever or other sign of infection.

Gastrointestinal: Overall, the incidence of gastrointestinal events (e. g. abdominal pain, dyspepsia, gastritis and constipation) in patients receiving PLAVIX (clopidogrel bisulfate) was 27. 1%, compared to 29.8% in those receiving aspirin.

The incidence of peptic, gastric or duodenal ulcers was 0.7% for PLAVIX and 1.2% for aspirin.

Cases of diarrhea were reported in 4.5% of patients in the PLAVIX group compared to 3.4% in the aspirin group. However, these were rarely severe (PLAVIX= 0.2% and aspirin= 0.1%).

The incidence of patients withdrawing from treatment because of gastrointestinal adverse reactions was 3.2% for PLAVIX and 4.0% for aspirin.

Rash and Other Skin Disorders: The incidence of skin and appendage disorders in patients receiving PLAVIX was 15.8% (0.7% serious); the corresponding rate in aspirin patients was 13.1% (0.5% serious).

The overall incidence of patients withdrawing from treatment because of skin and appendage disorders adverse reactions was 1.5% for PLAVIX and 0.8% for aspirin.

Adverse events occurring in 2.5% of patients on PLAVIX in the CAPRIE controlled clinical trial are shown below in table 2 regardless of relationship to PLAVIX. The median duration of therapy was 20 months, with a maximum of 3 years.

Table 2.
 

Adverse Events Occurring in 2.5% of PLAVIX Patients

Body System
Event

% Incidence (% Discontinuation)

PLAVIX
[n= 9599]

Aspirin
[n= 9586]

Body as a Whole - general disorders
Chest Pain

8.3 (0.2)

8.3 (0.3)

Accidental Injury

7.9 (0.1)

7.3 (0.1)

Influenza- like symptoms

7.5 (<0.1)

7.0 (<0.1)

Pain

6.4 (0.1)

6.3 (0.1)

Fatigue

3.3 (0.1)

3.4 (0.1)

Cardiovascular disorders, general
Edema

4.1 (<0.1)

4.5 (<0.1)

Hypertension

4.3 (<0.1)

5.1 (<0.1)

Central & peripheral nervous system disorders
Headache

7.6 (0.3)

7.2 (0.2)

Dizziness

6.2 (0.2)

6.7 (0.3)

Gastrointestinal system disorders
Abdominal pain

5.6 (0.7)

7.1 (1.0)

Dyspepsia

5.2 (0.6)

6.1 (0.7)

Diarrhea

4.5 (0.4)

3.4 (0.3)

Nausea

3.4 (0.5)

3.8 (0.4)

Metabolic & nutritional disorders
Hypercholesterolemia

4.0 (0)

4.4 (<0.1)

Musculo- skeletal system disorders
Arthralgia

6.3 (0.1)

6.2 (0.1)

Continued
Back Pain

5.8 (0.1)

5.3 (<0.1)

Platelet, bleeding, & clotting disorders
Purpura

5.3 (0.3)

3.7 (0.1)

Epistaxis

2.9 (0.2)

2.5 (0.1)

Psychiatric disorders
Depression

3.6 (0.1)

3.9 (0.2)

Respiratory system disorders
Upper resp tract infection

8.7 (<0.1)

8.3 (<0.1)

Dyspnea

4.5 (0.1)

4.7 (0.1)

Rhinitis

4.2 (0.1)

4.2 (<0.1)

Bronchitis

3.7 (0.1)

3.7 (0)

Coughing

3.1 (<0.1)

2.7 (<0.1)

Skin & appendage disorders
Rash

4.2 (0.5)

3.5 (0.2)

Pruritus

3.3 (0.3)

1.6 (0.1)

Urinary system disorders
Urinary tract infection

3.1 (0)

3.5 (0.1)

Incidence of discontinuation, regardless of relationship to therapy, is shown in parentheses.

Other adverse experiences of potential importance occurring in 1% to 2.5% of patients receiving PLAVIX (clopidogrel bisulfate) in the CAPRIE controlled clinical trial are listed below regardless of relationship to PLAVIX. In general, the incidence of these events was similar in the aspirin- treated group.

Autonomic Nervous System Disorders: Syncope, Palpitation.

Body as a Whole - general disorders: Asthenia, Hernia.

Cardiovascular disorders: Cardiac failure.

Central and peripheral nervous system disorders: Cramps legs, Hypoaesthesia, Neuralgia, Paraesthesia, Vertigo.

Gastrointestinal system disorders: Constipation, Vomiting.

Heart rate and rhythm disorders: Fibrillation atrial.

Liver and biliary system disorders: Hepatic enzymes increased.

Metabolic and nutritional disorders: Gout, hyperuricemia, non- protein nitrogen (NPN) increased.

Musculo- skeletal system disorders: Arthritis, Arthrosis. Platelet, bleeding & clotting disorders: GI hemorrhage, hematoma, platelets decreased.

Psychiatric disorders: Anxiety, Insomnia.

Red blood cell disorders: Anemia.

Respiratory system disorders: Pneumonia, Sinusitis.

Skin and appendage disorders: Eczema, Skin ulceration.

Urinary system disorders: Cystitis.

Vision disorders: Cataract, Conjunctivitis.

Other potentially serious adverse events which may be of clinical interest but were rarely reported (<1%) in patients who received PLAVIX are listed below regardless of relationship to PLAVIX. In general, the incidence of these events was similar in the aspirin group.

Body as a whole: Allergic reaction, necrosis ischemic.

Cardiovascular disorders: Edema generalized.

Gastrointestinal system disorders: Gastric ulcer perforated, gastritis hemorrhagic, upper GI ulcer hemorrhagic.

Liver and Biliary system disorders: Bilirubinemia, hepatitis infectious, liver fatty. Platelet, bleeding and clotting disorders: hemarthrosis, hematuria, hemoptysis, hemorrhage intracranial, hemorrhage retroperitoneal, hemorrhage of operative wound, ocular hemorrhage, pulmonary hemorrhage, purpura allergic, thrombocytopenia. Red blood cell disorders: Anemia aplastic, anemia hypochromic.

Reproductive disorders, female: Menorrhagia. Respiratory system disorders: Hemothorax.

Skin and appendage disorders: Bullous eruption, rash erythematous, rash maculopapular, urticaria. White cell and reticuloendothelial system disorders: Agranulocytosis, granulocytopenia, leukemia, leukopenia, neutrophils decreased.


DRUG INTERACTIONS

Study of specific drug interactions yielded the following results:

Aspirin: Aspirin did not modify the clopidogrel- mediated inhibition of A.P. induced platelet aggregation. Concomitant administration of 500 mg of aspirin twice a day for 1 day did not significantly increase the prolongation of bleeding time induced by PLAVIX. PLAVIX potentiated the effect of aspirin on collagen- induced platelet aggregation. The safety of chronic concomitant administration of aspirin and PLAVIX has not been established.

Heparin: In a study in healthy volunteers, PLAVIX did not necessitate modification of the heparin dose or alter the effect of heparin on coagulation. Coadministration of heparin had no effect on inhibition of platelet aggregation induced by PLAVIX. The safety of this combination has not been established, however, and concomitant use should be undertaken with caution.

Nonsteroidal Anti- Inflammatory Drugs (NSAIDs): In healthy volunteers receiving naproxen, concomitant administration of PLAVIX was associated with increased occult gastrointestinal blood loss. NSAIDs and PLAVIX should be coadministered with caution.

Warfarin: The safety of the coadministration of PLAVIX with warfarin has not been established. Consequently, concomitant administration of these two agents should be undertaken with caution.

Other Concomitant Therapy: No clinically significant pharmacodynamic interactions were observed when PLAVIX was coadministered with atenolol, nifedipine, or both atenolol and nifedipine. The pharmacodynamic activity of PLAVIX was also not significantly influenced by the coadministration of phenobarbital, cimetidine or estrogen.

The pharmacokinetics of digoxin or theophylline were not modified by the coadministration of PLAVIX (clopidogrel bisulfate). At high concentrations in vitro, clopidogrel inhibits P 450 (2C9). Accordingly, PLAVIX may interfere with the metabolism of phenytoin, tamoxifen, tolbutamide, warfarin, torsemide, fluvastatin, and many non-steroidal anti-inflammatory agents, but there are no data with which to predict the magnitude of these interactions. Caution should be used when any of these drugs is coadministered with PLAVIX.

In addition to the above specific interaction studies, patients entered into CAPRIE received a variety of concomitant medications including diuretics, beta-blocking agents, angiotensin converting enzyme inhibitors, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents, antiepileptic agents and hormone replacement therapy without evidence of clinically significant adverse interactions.

Drug/ Laboratory Test Interactions

None known.

 

 
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