Gemfibrozil (Page 4 of 5)

6. Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for gemfibrozil in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

7. Hematologic Changes

Mild hemoglobin, hematocrit, and white blood cell decreases have been observed in occasional patients following initiation of gemfibrozil therapy. However, these levels stabilize during long-term administration. Rarely, severe anemia, leukopenia, thrombocytopenia, and bone marrow hypoplasia have been reported. Therefore, periodic blood counts are recommended during the first 12 months of gemfibrozil administration.

8. Liver Function

Abnormal liver function tests have been observed occasionally during gemfibrozil administration, including elevations of AST, ALT, LDH, bilirubin, and alkaline phosphatase. These are usually reversible when gemfibrozil is discontinued. Therefore, periodic liver function studies are recommended and gemfibrozil therapy should be terminated if abnormalities persist.

9. Kidney Function

There have been reports of worsening renal insufficiency upon the addition of gemfibrozil therapy in individuals with baseline plasma creatinine >2.0 mg/dL. In such patients, the use of alternative therapy should be considered against the risks and benefits of a lower dose of gemfibrozil.

10. Pediatric Use

Safety and efficacy in pediatric patients have not been established.

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 PLACEBO
(N = 2046) (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 1.2 0.6
(histologically confirmed in most
cases where data were available)
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 CAUSAL RELATIONSHIP
PROBABLE 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 Interactionsunder 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).

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