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:
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 compared to the placebo
group of the WHO study. Gallbladder surgery was also performed more frequently in the
LOPID group compared to placebo (1.9% vs 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 vs 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.