Gemfibrozil precautions

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

List of precautions

Initial Therapy

Continued Therapy

Pregnancy Category C

Nursing Mothers

Hematologic Changes

Liver Function

Kidney Function

Pediatric Use

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Initial Therapy

Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal. Before instituting LOPID therapy, every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Return to top

Continued Therapy

Periodic determination of serum lipids should be obtained, and the drug withdrawn if lipid response is inadequate after three months of therapy. Return to top

Pregnancy Category C

LOPID has been shown to produce adverse effects in rats and rabbits at doses between 0.5 and 3 times the human dose (based on surface area). There are no adequate and well-controlled studies in pregnant women. LOPID should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Administration of LOPID to female rats at2 times the human dose (based on surface area) before and throughout gestation caused a dose-related decrease in conception rate and, an increase in stillborns and a slight reduction in pup weight during lactation. There were also dose-related increased skeletal variations. Anophthalmia occurred, but rarely. Return to top

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 LOPID 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. Return to top

Hematologic Changes

Mild hemoglobin, hematocrit and white blood cell decreases have been observed in occasional patients following initiation of LOPID 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 LOPID administration. Return to top

Liver Function

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

Kidney Function

There have been reports of worsening renal insufficiency upon the addition of LOPID 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 LOPID. Return to top

Pediatric Use

Safety and efficacy in pediatric patients have not been established. Return to top

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Adapted from the FDA Package Insert.