Lescol Side Effects

Generic Name: fluvastatin

Please note - some side effects for Lescol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lescol - for the Consumer

Lescol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lescol:

Headache; stomach pain or upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; chest pain; dark urine; fever, chills, or persistent sore throat; flu-like symptoms; joint pain; mental or mood changes; muscle pain, tenderness, or weakness (with or without fever or fatigue); numbness or tingling of the skin, arm, or leg; painful or frequent urination; pale stools; red, swollen, blistered, or peeling skin; severe stomach pain; yellowing of the eyes or skin.

Lescol XL Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lescol XL Extended-Release Tablets:

Headache; stomach pain or upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; chest pain; dark urine; decreased sexual desire or ability; fever, chills, or persistent sore throat; flu-like symptoms; joint pain; mental or mood changes; muscle pain, tenderness, or weakness (with or without fever or fatigue); numbness or tingling of the skin, arm, or leg; painful or frequent urination; pale stools; red, swollen, blistered, or peeling skin; severe stomach pain; yellowing of the eyes or skin.

Lescol Side Effects - for the Professional

Lescol

In all clinical studies of Lescol® (fluvastatin sodium), 1.0% (32/2969) of fluvastatin-treated patients were discontinued due to adverse experiences attributed to study drug (mean exposure approximately 16 months ranging in duration from 1 to >36 months). This results in an exposure adjusted rate of 0.8% (32/4051) per patient year in fluvastatin patients in controlled studies compared to an incidence of 1.1% (4/355) in placebo patients. Adverse reactions have usually been of mild to moderate severity.

      In controlled clinical studies, 3.9% (36/912) of patients treated with Lescol® XL (fluvastatin sodium) 80 mg discontinued due to adverse events (causality not determined).

      Clinically relevant adverse experiences occurring in the Lescol and Lescol XL controlled studies with a frequency >2%, regardless of causality, include the following:

1 Controlled trials with Lescol Capsules (20 and 40 mg daily and 40 mg twice daily)

2 Controlled trials with Lescol XL 80 mg Tablets

      The following effects have been reported with drugs in this class. Not all the effects listed below have necessarily been associated with fluvastatin sodium therapy.

Skeletal: muscle cramps, myalgia, myopathy, rhabdomyolysis, arthralgias.

Neurological: dysfunction of certain cranial nerves (including alteration of taste, impairment of extra-ocular movement, facial paresis), tremor, dizziness, vertigo, memory loss, paresthesia, peripheral neuropathy, peripheral nerve palsy, psychic disturbances, anxiety, insomnia, depression.

Hypersensitivity Reactions: An apparent hypersensitivity syndrome has been reported rarely which has included one or more of the following features: anaphylaxis, angioedema, lupus erythematosus-like syndrome, polymyalgia rheumatica, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome.

Gastrointestinal: pancreatitis, hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in liver, and, rarely, cirrhosis, fulminant hepatic necrosis, and hepatoma; anorexia, vomiting.

Skin: alopecia, pruritus. A variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails) have been reported.

Reproductive: gynecomastia, loss of libido, erectile dysfunction.

Eye: progression of cataracts (lens opacities), ophthalmoplegia.

Laboratory Abnormalities: elevated transaminases, alkaline phosphatase, γ-glutamyl transpeptidase, and bilirubin; thyroid function abnormalities.

Pediatric Patients

In two open-label, uncontrolled studies, 114 patients (66 boys and 48 girls) with heterozygous familial hypercholesterolemia, 9-16 years of age, were treated for 2 years with fluvastatin sodium administered as Lescol capsules 20 mg- 40 mg bid or Lescol XL 80 mg extended-release tablets. The most common adverse events observed were influenza and infections..

Concomitant Therapy

Fluvastatin sodium has been administered concurrently with cholestyramine and nicotinic acid. No adverse reactions unique to the combination or in addition to those previously reported for this class of drugs alone have been reported. Myopathy and rhabdomyolysis (with or without acute renal failure) have been reported when another HMG-CoA reductase inhibitor was used in combination with immunosuppressive drugs, gemfibrozil, erythromycin, or lipid-lowering doses of nicotinic acid. Concomitant therapy with HMG-CoA reductase inhibitors and these agents is generally not recommended.

Side Effects by Body System

Hepatic

Hepatic side effects of fluvastatin include elevations in liver function tests (1.1%). Other hepatic side effects reported with HMG-CoA reductase inhibitors include hepatitis, cholestatic jaundice, fatty changes in the liver, cirrhosis, hepatoma, and fulminant hepatic necrosis.

Persistent elevations in liver function tests three times normal values were reported in up to 1.1% of patients of fluvastatin in clinical trials. This led to discontinuation of fluvastatin in 0.7% of patients. The majority of these patients were asymptomatic.

Liver function tests should be closely monitored. It is recommended that fluvastatin be discontinued in patients with persistent, significant elevations (three times normal) in liver function parameters.

Carcinogenicity studies in animals have demonstrated that liver tumors can be induced in rodents with long-term HMG-CoA reductase inhibitors. However, a recent carcinogenicity study in animals receiving fluvastatin found no evidence of liver tumors.

The manufacturer reports that the incidence of increased transaminase levels was not increased in patients who took the 80 mg dose of fluvastatin versus lower doses. Of 343 patients treated with the 80 mg dose for an average of 51 weeks, 6 patients (1.7%) discontinued fluvastatin due to AST and/or ALT elevations. The overall incidence of transaminase elevations with the 80 mg dose was 0.9% compared with 1.0% with all fluvastatin dosages in controlled trials. This data was extracted from the Fluvastatin Long-Term Extension Trial (FLUENT), 1994.

Musculoskeletal

Musculoskeletal side effects have included elevations in creatine kinase, myopathy, back pain, and arthropathy. Rhabdomyolysis with renal dysfunction secondary to myoglobinuria has been reported with fluvastatin and other HMG-CoA reductase inhibitors. Musculoskeletal side effects reported with other HMG-CoA reductase inhibitors have included arthralgia, tendon rupture, dermatomyositis, and myalgia.

In addition, some data have suggested that exposure to HMG-CoA reductase inhibitors is associated with a decreased risk of bone fractures in persons older than 50 years of age.

HMG-CoA reductase inhibitors (statins) have been associated with rare cases of severe myopathy and rhabdomyolysis, accompanied by increases in creatine kinase, myoglobinuria, proteinuria, and renal failure. Concomitant use with gemfibrozil (fibric acid derivatives), niacin, cyclosporine, erythromycin (macrolides) or azole antifungals may increase the incidence and severity of musculoskeletal side effects. Other variables associated with an increased risk of statin-induced myopathy include, advanced age, small body stature, female gender, renal and/or hepatic dysfunction, perioperative periods, hypothyroidism, diabetes mellitus, and alcoholism.

Milder forms of myotoxicity (i.e., myalgia) are commonly reported and occur in approximately 5% to 7% of patients taking a statin drug.

Patients should be instructed to report symptoms of muscle pain, weakness, or tenderness. If such symptoms develop, creatine kinase should be measured, and if elevated, fluvastatin should be discontinued. The value of regular monitoring of creatine kinase is not known.

Gastrointestinal

Gastrointestinal side effects have included dyspepsia (8.1%), diarrhea (6.0%), abdominal pain (5.5%), nausea, constipation, and flatulence. Other HMG-CoA reductase inhibitors have been associated with pancreatitis, anorexia, and vomiting.

Hematologic

Hematologic side effects including hemolytic anemia, thrombocytopenia, thrombotic thrombocytopenic purpura (TTP), and leukopenia have occurred with HMG-CoA reductase inhibitors. These effects may be manifestations of a hypersensitivity reaction.

Nervous system

Nervous system side effects have included headache (8.7%), fatigue (3.5%), and dizziness (2.5%). Other nervous system side effects reported with HMG-CoA reductase inhibitors include cranial nerve dysfunction, tremor, vertigo, drowsiness, weight loss, decline in cognitive function, memory loss, paresthesias, peripheral neuropathy, and peripheral nerve palsy.

Dermatologic

Dermatologic effects have included rash (2.7%). Alopecia and pruritus have been reported with other HMG-CoA reductase inhibitors.

Hypersensitivity

Hypersensitivity syndrome has been rarely reported with HMG-CoA reductase inhibitors and is characterized by one or more symptoms, including anaphylaxis, angioedema, lupus erythematosus-like syndrome, polymyalgia rheumatica, vasculitis, purpura, thrombocytopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, urticaria, and asthenia.

Genitourinary

Genitourinary side effects of HMG-CoA reductase inhibitors have included erectile dysfunction, impotence, and testicular pain.

Halkin, et al report a case in which use of both lovastatin and pravastatin on different occasions in the same patient lead to reversible impotence. The impotence resolved within 2 weeks after discontinuation of the HMG-CoA reductase inhibitor.

Oncologic

Oncologic side effects including tumor growth in rodents have been associated with many lipid-lowering drugs. Fluvastatin has been specifically associated with thyroid and stomach adenomas in the rat and mouse. Long-term clinical trials are needed to define the risk of cancer in humans.

Endocrine

Endocrine side effects associated with HMG-CoA reductase inhibitors have included hypospermia, gynecomastia and thyroid function abnormalities. In addition, acid maltase deficiency (the genetic disorder also referred to as Pompe's Disease) has been revealed following HMG-CoA therapy in at least one presymptomatic patient.

Psychiatric

Psychiatric side effects associated with HMG-CoA reductase inhibitors have included decreased libido, anxiety, insomnia, depression, suicidal thoughts, delusions, paranoia, agitation, and nightmares.

Renal

Renal side effects including acute renal failure secondary to rhabdomyolysis has been reported with HMG-CoA reductase inhibitors.

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