Does Lescol (Fluvastatin) cause side effects?
Lescol (Fluvastatin) is an HMG-CoA reductase inhibitor (a statin) used to reduce total blood cholesterol, LDL cholesterol, triglycerides, and increase HDL cholesterol levels in conjunction with a healthy diet. Lescol is also prescribed to reduce the risks of coronary revascularization procedures and slows the progression of coronary heart disease.
Statins reduce cholesterol by inhibiting an enzyme in the liver (HMG-CoA reductase) necessary for the production of cholesterol. In the blood, statins lower total and LDL ("bad") cholesterol as well as triglycerides.
LDL cholesterol is believed to be an important cause of coronary artery disease. Lowering LDL cholesterol levels slows and may even reverse coronary artery disease. Statins also increase HDL ("good") cholesterol. Raising HDL cholesterol levels, like lowering LDL cholesterol, may slow coronary artery disease.
Common side effects of Lescol include
- joint pains,
- abdominal pain or cramps,
- blurred vision,
- easy bruising or bleeding,
- muscle pain or cramps,
- rash, and
- yellowing of the skin or eyes (jaundice).
Serious side effects of Lescol include
- serious breakdown of muscle cells (rhabdomyolysis) that can lead to kidney failure and even death,
- liver damage,
- increases in HbA1c and fasting serum glucose levels,
- memory loss,
- confusion, and
- memory impairment.
- Gemfibrozil should not be combined with Lescol due to increased risk of muscle-related side effects when the two drugs are combined.
- Combining Lescol with colchicine or one gram or larger doses of niacin also increases the risk of muscle-related side effects.
- Lescol increases the effect of warfarin.
What are the important side effects of Lescol (Fluvastatin)?
Minor side effects of fluvastin include:
Major side effects include:
- abdominal pain or cramps,
- blurred vision,
- easy bruising or bleeding,
- muscle pain or cramps,
- rash, and
- yellowing of the skin or eyes.
Inflammation of the muscles caused by statins can lead to a serious breakdown of muscle cells called rhabdomyolysis. Rhabdomyolysis causes the release of muscle protein (myoglobin) into the blood. Myoglobin can cause kidney failure and even death. When used alone, statins cause rhabdomyolysis in less than one percent of patients.
To prevent the development of rhabdomyolysis, patients taking fluvastatin should contact their health care professional immediately if they develop unexplained muscle pain, weakness, or muscle tenderness.
Statins may cause liver damage although serious liver damage is rare. Blood liver tests should be performed at the beginning of treatment and as needed thereafter to detect liver injury.
Statins have been associated with increases in HbA1c and fasting serum glucose levels.
There are also post-marketing reports of
- memory loss,
- confusion, and
- memory impairment.
Symptoms may start one day to years after starting treatment and resolve within a median of three weeks after stopping the statin.
Lescol (Fluvastatin) side effects list for healthcare professionals
The following serious adverse reactions are discussed in greater detail in other sections of the label:
- Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis).
- Liver Enzyme Abnormalities.
Clinical Studies Experience in Adult Patients
Because clinical studies on Lescol/Lescol XL are conducted in varying study populations and study designs, the frequency of adverse reactions observed in the clinical studies of Lescol/Lescol XL cannot be directly compared with that in the clinical studies of other statins and may not reflect the frequency of adverse reactions observed in clinical practice.
In the Lescol placebo-controlled clinical trials database of 2326 patients treated with Lescol1 (age range 18-75 years, 44% women, 94% Caucasians, 4% Blacks, 2% other ethnicities) with a median treatment duration of 24 weeks, 3.4% of patients on Lescol and 2.3% patients on placebo discontinued due to adverse reactions regardless of causality.
The most common adverse reactions that led to treatment discontinuation and occurred at an incidence greater than placebo were:
- transaminase increased (0.8%),
- upper abdominal pain (0.3%),
- dyspepsia (0.3%),
- fatigue (0.2%) and
- diarrhea (0.2%).
In the Lescol XL database of controlled clinical trials of 912 patients treated with Lescol XL (age range 21-87 years, 52% women, 91% Caucasians, 4% Blacks, 5% other ethnicities) with a median treatment duration of 24 weeks, 3.9% of patients on Lescol XL discontinued due to adverse reactions regardless of causality.
The most common adverse reactions that led to treatment discontinuation were
Clinically relevant adverse experiences occurring in the Lescol and Lescol XL controlled studies with a frequency > 2%, regardless of causality, included the following:
Table 1 : Clinical adverse events reported in > 2% in patients treated with Lescol/Lescol XL and at an incidence greater than placebo in placebo-controlled trials regardless of causality (% of patients) Pooled Dosages
|Genitourinary||Urinary tract infection||1.6||1.1||2.7|
|1Controlled trials with Lescol Capsules (20 and 40 mg daily and 40 mg twice daily) compared to placebo|
2Controlled trials with Lescol XL 80 mg Tablets as compared to Lescol Capsules
Lescol Intervention Prevention Study
In the Lescol Intervention Prevention Study (LIPS), the effect of Lescol 40 mg, administered twice daily on the risk of recurrent cardiac events was assessed in 1677 patients with CHD who had undergone a percutaneous coronary intervention (PCI) procedure.
This was a multicenter, randomized, double-blind, placebo-controlled study, patients were treated with dietary/lifestyle counseling and either Lescol 40 mg (n=844) or placebo (n=833) given twice daily for a median of 3.9 years.
Table 2 : Clinical adverse events reported in ≥ 2% in patients treated with Lescol/Lescol XL and at an incidence greater than placebo in the LIPS Trial regardless of causality (% of patients)
|Lescol 40 mg b.i.d|
|Cardiac disorders||Atrial fibrillation||2.4||2.0|
|Gastrointestinal disorders||Abdominal pain upper||6.3||4.5|
|Infections and infestations||Bronchitis||2.3||2.0|
|Musculoskeletal and connective tissue disorders||Arthralgia||2.1||1.8|
|Pain in extremity||4.1||2.7|
|Nervous system disorders||Dizziness||3.9||3.5|
|Respiratory disorders||Dyspnea exertional||2.8||2.4|
Clinical Studies Experience in Pediatric Patients
In patients aged < 18 years, efficacy and safety have not been studied for treatment periods longer than two years.
In two open-label, uncontrolled studies, 66 boys and 48 girls with heterozygous familial hypercholesterolemia ( 9-16 years of age, 80% Caucasian, 19% Other [ mixed ethnicity], 1% Asians) were treated with fluvastatin sodium administered as Lescol capsules 20 mg -40 mg twice daily, or Lescol XL 80 mg extended-release tablet.
Because adverse reactions from spontaneous reports are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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.
- Musculoskeletal: muscle cramps, myalgia, myopathy, rhabdomyolysis, arthralgias, muscle spasms, muscle weakness, myositis.
- Neurological: dysfunction of certain cranial nerves (including alteration of taste, impairment of extra-ocular movement, facial paresis), tremor, dizziness, vertigo, paresthesia, hypoesthesia, dysesthesia, peripheral neuropathy, peripheral nerve palsy.
- There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
- Psychiatric: anxiety, insomnia, depression, psychic disturbances
- 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 (erythrocyte sedimentation rate) increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity reaction, 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, cirrhosis, fulminant hepatic necrosis, hepatoma, anorexia, vomiting, fatal and non-fatal hepatic failure.
- Skin: rash, dermatitis, including bullous dermatitis, eczema, alopecia, pruritus, a variety of skin changes (e.g. nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails).
- Reproductive: gynecomastia, loss of libido, erectile dysfunction.
- Eye: progression of cataracts (lens opacities), ophthalmoplegia.
- Laboratory abnormalities: elevated transaminases, alkaline phosphatase, gamma-glutamyl transpeptidase and bilirubin; thyroid function abnormalities.
What drugs interact with Lescol (Fluvastatin)?
- Cyclosporine coadministration increases fluvastatin exposure. Therefore, in patients taking cyclosporine, therapy should be limited to Lescol 20 mg twice daily.
- Administration of fluvastatin 40 mg single dose to healthy volunteers pre-treated with fluconazole for 4 days results in an increase of fluvastatin exposure.
- Therefore, in patients taking fluconazole, therapy should be limited to Lescol 20 mg twice daily.
- Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are coadministered with gemfibrozil, concomitant administration of Lescol/Lescol XL with gemfibrozil should be avoided.
- Because it is known that the risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concurrent administration of other fibrates, Lescol/Lescol XL should be administered with caution when used concomitantly with other fibrates.
- The risk of skeletal muscle effects may be enhanced when Lescol is used in combination with lipid-modifying doses ( = 1 g/day) of niacin; a reduction in Lescol dosage should be considered in this setting.
- Concomitant administration of fluvastatin and glyburide increased glyburide exposures. Patients on concomitant therapy of glyburide and fluvastatin should continue to be monitored appropriately.
Concomitant administration of fluvastatin and phenytoin increased phenytoin exposures. Patients should continue to be monitored appropriately when fluvastatin therapy is initiated or when fluvastatin dose is changed.
Bleeding and/or increased prothrombin times have been reported in patients taking coumarin anticoagulants concomitantly with other HMG-CoA reductase inhibitors. Therefore, patients receiving warfarin-type anticoagulants should have their prothrombin times closely monitored when fluvastatin sodium is initiated or the dosage of fluvastatin sodium is changed.
Cases of myopathy, including rhabdomyolysis, have been reported with fluvastatin coadministered with colchicine, and caution should be exercised when prescribing fluvastatin with colchicine.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.