GEMFIBROZIL (Page 4 of 5)

ADVERSE REACTIONS

In the double-blind controlled phase of the primary prevention component of the Helsinki Heart Study, 2046 patients received gemfibrozil for up to five years. In that study, the following adverse reactions were statistically more frequent in subjects in the gemfibrozil group:

GEMFIBROZIL

(N=2046)

PLACEBO

(N=2035)

Frequency in percent of subjects

Gastrointestinal reactions

34.2

23.8

Dyspepsia

19.6

11.9

Abdominal pain

9.8

5.6

Acute appendicitis

(histologically confirmed in most cases where data were available)

1.2

0.6

Atrial fibrillation

0.7

0.1

Adverse events reported by more than 1% of subjects, but without a significant difference between groups:

Diarrhea

7.2

6.5

Fatigue

3.8

3.5

Nausea/Vomiting

2.5

2.1

Eczema

1.9

1.2

Rash

1.7

1.3

Vertigo

1.5

1.3

Constipation

1.4

1.3

Headache

1.2

1.1

Gallbladder surgery was performed in 0.9% of gemfibrozil and 0.5% of placebo subjects in the primary prevention component, a 64% excess, which is not statistically different from the excess of gallbladder surgery observed in the clofibrate group compared to the placebo group of the WHO study.

Gallbladder surgery was also performed more frequently in the gemfibrozil group compared to the placebo group (1.9% versus 0.3%, p=0.07) in the secondary prevention component. A statistically significant increase in appendectomy in the gemfibrozil group was seen also in the secondary prevention component (6 on gemfibrozil versus 0 on placebo, p=0.014).

Nervous system and special senses adverse reactions were more common in the gemfibrozil group. These included hypesthesia, paresthesias, and taste perversion. Other adverse reactions that were more common among gemfibrozil treatment group subjects but where a causal relationship was not established include cataracts, peripheral vascular disease, and intracerebral hemorrhage.

From other studies it seems probable that gemfibrozil is causally related to the occurrence of MUSCULOSKELETAL SYMPTOMS (see WARNINGS), and to ABNORMAL LIVER FUNCTION TESTS and HEMATOLOGIC CHANGES (see PRECAUTIONS).

Reports of viral and bacterial infections (common cold, cough, urinary tract infections) were more common in gemfibrozil treated patients in other controlled clinical trials of 805 patients. Additional adverse reactions that have been reported for gemfibrozil are listed below by system. These are categorized according to whether a causal relationship to treatment with gemfibrozil is probable or not established:

CAUSAL RELATIONSHIP PROBABLE

CAUSAL RELATIONSHIP NOT ESTABLISHED

General:

weight loss

Cardiac:

extrasystoles

Gastrointestinal:

cholestatic jaundice

pancreatitis

hepatoma

colitis

Central Nervous System:

Dizziness

Confusion

Somnolence

Convulsions

Paresthesia

Syncope

peripheral neuritis

decreased libido

Depression

Headache

Eye:

blurred vision

retinal edema

Genitourinary:

Impotence

decreased male fertility

renal dysfunction

Musculoskeletal:

Myopathy

Myasthenia

Myalgia

painful extremities

Arthralgia

Synovitis

rhabdomyolysis (see WARNINGS and Drug Interactions under PRECAUTIONS)

Clinical Laboratory:

increased creatine phosphokinase

positive antinuclear antibody

increased bilirubin

increased liver transaminases (AST, ALT)

increased alkaline phosphatase

Hematopoietic:

Anemia

Thrombocytopenia

Leukopenia

bone marrow hypoplasia

Eosinophilia

Immunologic:

Angioedema

Anaphylaxis

laryngeal edema

Lupus-like syndrome

Urticaria

Vasculitis

Integumentary:

exfoliative dermatitis

Alopecia

Rash

Photosensitivity

Dermatitis

Pruritus

Additional adverse reactions that have been reported include cholecystitis and cholelithiasis (see WARNINGS).

DOSAGE AND ADMINISTRATION

The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).

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