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LOPID® (gemfibrozil) Adverse Reactions

ADVERSE REACTIONS

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

LOPID
(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   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 LOPID 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 LOPID 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 LOPID group. These included hypesthesia, paresthesias, and taste perversion. Other adverse reactions that were more common among LOPID 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 LOPID 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 LOPID is probable or not established:

CAUSAL RELATIONSHIP
PROBABLE
CAUSAL RELATIONSHIP
NOT ESTABLISHED
General:
Cardiac:
weight loss
extrasystoles
Gastrointestinal: cholestatic jaundice pancreatitis
hepatoma
colitis
Central Nervous
  System: dizziness
somnolence
paresthesia
peripheral neuritis
decreased libido
depression
headache
confusion
convulsions
syncope
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
increased bilirubin
increased liver
  transaminases
  (AST, ALT)
increased alkaline
  phosphatase
positive antinuclear
  antibody
Hematopoietic: anemia
leukopenia
bone marrow hypoplasia
eosinophilia
thrombocytopenia
Immunologic: angioedema
laryngeal edema
urticaria
anaphylaxis
Lupus-like syndrome
vasculitis
Integumentary: exfoliative dermatitis
rash
dermatitis
pruritus
alopecia
photosensitivity

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

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