Fluvastatin contraindications
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Contraindications
Hypersensitivity to any Component of this Medication
LESCOL and LESCOL XL are contraindicated in patients with hypersensitivity to any component of this medication.
Active Liver Disease
LESCOL and LESCOL XL are contraindicated in patients with active liver disease or unexplained, persistent elevations in serum transaminases [see Warnings and Precautions (5.2)].
Pregnancy
LESCOL and LESCOL XL are contraindicated in women who are pregnant or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. LESCOL and LESCOL XL may cause fetal harm when administered to pregnant women. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia.
LESCOL and LESCOL XL should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, LESCOL and LESCOL XL should be discontinued and the patient should be apprised of the potential hazard to the fetus [see Use In Specific Populations (8.1)].
Nursing Mothers
Fluvastatin is secreted into the breast milk of animals and because HMG-CoA reductase inhibitors have the potential to cause serious adverse reactions in nursing infants, women who require treatment with LESCOL or LESCOL XL should be advised not to breastfeed their infants [see Use In Specific Populations (8.3)].[1]