{ "query": "lovastatin", "ingredient": "lovastatin", "slug": "lovastatin", "rxcui": "6472", "brands": [ "Altoprev" ], "names": [ "lovastatin" ], "classes": [ { "id": "C10AA", "name": "HMG CoA reductase inhibitors" } ], "alternatives": [ "atorvastatin", "cerivastatin", "fluvastatin", "pitavastatin", "pravastatin", "rosuvastatin", "simvastatin" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 55 }, "boxed_warning": "", "indications_and_usage": "INDICATIONS AND USAGE Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, lovastatin is indicated to reduce the risk of: Myocardial infarction Unstable angina Coronary revascularization procedures (See CLINICAL PHARMACOLOGY , Clinical Studies .) Coronary Heart Disease Lovastatin is indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk f...", "contraindications": "CONTRAINDICATIONS Hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases (see WARNINGS ). Concomitant administration with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin ,nefazodone, and cobicistat-containing products) (see WARNINGS , Myopathy/Rhabdomyolysis ) . Pregnancy and lactation. ( see PRECAUTIONS, Pregnancy and Nursing Mothers ). 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. Moreover, cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase such as lovastatin to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, lovastatin is contraindicated during pregnancy and in nursing mothers. Lovastatin ...", "warnings_and_cautions": "", "warnings": "WARNINGS Myopathy/Rhabdomyolysis Lovastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above 10 times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy is increased by high levels of HMG-CoA reductase inhibitory activity in plasma. The risk of myopathy/rhabdomyolysis is dose related. In a clinical study (EXCEL) in which patients were carefully monitored and some interacting drugs were excluded, there was one case of myopathy among 4933 patients randomized to lovastatin 20 to 40 mg daily for 48 weeks, and 4 among 1649 patients randomized to 80 mg daily. All patients starting therapy with lovastatin, or whose dose of lovastatin is being increased, should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing Lovastatin. Lovastatin therapy should be discontinued ...", "adverse_reactions": "ADVERSE REACTIONS ____________________________________ 3 Manson, J.M., Freyssinges, C., Ducrocq, M.B., Stephenson, W.P., Postmarketing Surveillance of Lovastatin and Simvastatin Exposure During Pregnancy. Reproductive Toxicology . 10(6):439-446. 1996. Phase III Clinical Studies In Phase III controlled clinical studies involving 613 patients treated with lovastatin, the adverse experience profile was similar to that shown below for the 8,245-patient EXCEL study (see Expanded Clinical Evaluation of Lovastatin [EXCEL] Study ). Persistent increases of serum transaminases have been noted (see WARNINGS , Liver Dysfunction ). About 11% of patients had elevations of CK levels of at least twice the normal value on one or more occasions. The corresponding values for the control agent cholestyramine was 9 percent. This was attributable to the noncardiac fraction of CK. Large increases in CK have sometimes been reported (see WARNINGS , Myopathy/Rhabdomyolysis ). Expanded Clinical Evaluation of Lovastatin (EXCEL) Study Lovastatin was compared to placebo in 8,245 patients with hypercholesterolemia (total-C 240-300 mg/dL [6.2-7.8 mmol/L]) in the randomized, double-blind, parallel, 48-week EXCEL s...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "Information for Patients Patients should be advised about substances they should not take concomitantly with lovastatin and be advised to report promptly unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discountinuing Lovastatin (see list below and WARNINGS , Myopathy/Rhabdomyolysis ) . Patients should also be advised to inform other physicians prescribing a new medication that they are taking lovastatin. It is recommended that liver enzymes be checked before starting therapy, and if signs or symptoms of liver injury occur. All patients treated with Lovastatin should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.", "spl_medguide": "", "clinical_studies": "Clinical Studies in Adults Lovastatin has been shown to reduce total-C and LDL-C in heterozygous familial and non-familial forms of primary hypercholesterolemia and in mixed hyperlipidemia. A marked response was seen within 2 weeks, and the maximum therapeutic response occurred within 4 to 6 weeks. The response was maintained during continuation of therapy. Single daily doses given in the evening were more effective than the same dose given in the morning, perhaps because cholesterol is synthesized mainly at night. In multicenter, double-blind studies in patients with familial or non-familial hypercholesterolemia, lovastatin, administered in doses ranging from 10 mg q.p.m. to 40 mg b.i.d., was compared to placebo. Lovastatin significantly decreased plasma total-C, LDL-C, total-C/HDL-C ratio and LDL-C/HDL-C ratio. In addition, lovastatin produced increases of variable magnitude in HDL-C, and modestly decreased VLDL-C and plasma TG (see Tables II through IV for dose response results). The results of a study in patients with primary hypercholesterolemia are presented in Table II . TABLE II Lovastatin vs Placebo (Mean Percent Change from Baseline After 6 Weeks) DOSAGE N TOTAL-C LDL-C H...", "brand_name": "Lovastatin", "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC", "application_number": "ANDA075991", "pharm_class_epc": [ "HMG-CoA Reductase Inhibitor [EPC]" ], "route": [ "ORAL" ], "effective_time": "20240123", "set_id": "0399c35c-513d-48e6-aa20-e8434e3b18d5", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 17492, "serious": 9622, "death": 1451, "hospitalization": 4518, "primary_suspect": 17461, "top_reactions": [ [ "Drug Ineffective", 1134 ], [ "Fatigue", 1123 ], [ "Diarrhoea", 942 ], [ "Nausea", 827 ], [ "Chronic Kidney Disease", 782 ], [ "Off Label Use", 752 ], [ "Dyspnoea", 747 ], [ "Pain", 683 ], [ "Death", 681 ], [ "Dizziness", 680 ], [ "Headache", 667 ], [ "Asthenia", 656 ], [ "Fall", 618 ], [ "Acute Kidney Injury", 560 ], [ "Arthralgia", 514 ] ], "by_year": { "2019": 1839, "2020": 1445, "2021": 1096, "2022": 909, "2023": 788, "2024": 687, "2025": 647, "2026": 283 }, "by_year_primary": { "2019": 1837, "2020": 1444, "2021": 1096, "2022": 901, "2023": 781, "2024": 687, "2025": 641, "2026": 277 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class III", "date": "20190213", "reason": "CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.", "firm": "Lupin Pharmaceuticals Inc.", "status": "Terminated" } ], "recall_total": 1, "drugsfda": { "applications": 12, "nda": 2, "anda": 10, "first_approval": "19870831", "rems": false, "rems_last": "", "labeling_supplements": 56, "labeling_recent": 1, "sponsors": [ "ACTAVIS ELIZABETH", "AUROBINDO PHARMA USA", "AZURITY", "CARLSBAD", "CHARTWELL RX", "EPIC PHARMA LLC", "LUPIN", "MACLEODS PHARMS" ], "unapproved": false, "first_approval_fmt": "08/31/1987" }, "trials": { "total": 640, "completed": 434, "terminated": 76, "with_results": 169, "industry": 240, "phase3": 156, "results_share": 0.38940092165898615, "terminated_share": 0.11875 }, "pubmed": { "rct": 212, "meta": 0, "recent_rct": 5, "cochrane": [] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "lovastatin", "Altoprev" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 2542461, "beneficiaries": 628985, "spend": 26090925.62, "by_brand": [ { "brand": "Lovastatin", "claims": 2541780, "per_claim": 9.8610736177, "is_generic": true }, { "brand": "Altoprev", "claims": 681, "per_claim": 1506.9690455, "is_generic": false } ], "per_claim": 10.262075060345076 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": true, "status": "AddedToEml", "name": "lovastatin", "matched": "lovastatin", "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 1605, "fills": 2542461, "per_million": 631.2781199003642, "ratio": 0.22798467868050035, "median": 2768.949753790441 }, "scores": { "safety": { "score": 100, "letter": "A", "why": [ "631 FDA reports naming it as the suspect drug per million Medicare fills, 0.2x the median drug on this site", "Death share in reports is near or below the FAERS average (0.9x)" ], "weight": 0.35 }, "evidence": { "score": 34, "letter": "F", "why": [ "212 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed", "On the WHO Model List of Essential Medicines (shown for context; no score effect)", "No Cochrane review found (-5)", "Only 39% of completed registered trials posted results (-8)", "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)" ], "weight": 0.25 }, "regulatory": { "score": 100, "letter": "A", "why": [ "Recalls since 2016: 0 Class I, 0 Class II, 1 Class III across 10 generic makers (-0)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $0 tied to this drug last year: negligible", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 100, "letter": "A", "why": [ "Generic versions approved (10 applications)", "7 same-class alternatives exist" ], "weight": 0.1 } }, "total": 84, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are fatigue, diarrhoea, nausea. How would we recognize and handle those?", "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?", "Why this one over atorvastatin, cerivastatin, fluvastatin? What would make you pick one of those instead?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }