- Does Advicor (niacin and lovastatin) cause side effects?
- What are the side effects of Advicor (niacin and lovastatin)?
- Advicor (niacin and lovastatin) side effects list for healthcare professionals
- Does Advicor (niacin and lovastatin) cause withdrawal or addiction symptoms?
- What drugs interact with Advicor (niacin and lovastatin)?
Does Advicor (niacin and lovastatin) cause side effects?
Advicor (niacin and lovastatin) is a combination of niacin (vitamin B3) and an HMG-CoA reductase inhibitor (a "statin") used for lowering cholesterol levels in the blood. It reduces blood levels of total cholesterol, low density lipoprotein (LDL) cholesterol, and triglycerides and increases blood levels of high-density lipoprotein (HDL) cholesterol.
Niacin is a part of a normal diet that is essential for various chemical reactions in the body. Doses of niacin larger than normal dietary needs reduce cholesterol and triglyceride levels in the blood. Niacin reduces bad cholesterol (LDL cholesterol) and increases good cholesterol (HDL cholesterol).
Lovastatin is a statins drug that reduces cholesterol by inhibiting an enzyme in the liver (HMG-CoA reductase) necessary for the production of cholesterol. In the blood, statins lower LDL cholesterol and 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 cholesterol. Raising HDL cholesterol levels, like lowering LDL cholesterol may slow coronary artery disease. The combination of niacin and lovastatin is better than either drug alone in reducing cholesterol, reducing triglycerides, and increasing HDL.
Common side effects of Advicor include
- skin redness,
- warm sensation,
- stomach upset,
- muscle pain, and
- tingling in extremities.
Serious side effects of Advicor include
- liver test abnormalities,
- liver damage,
- muscle wasting (rhabdomyolysis),
- kidney failure,
- muscle pain,
- muscle tenderness,
- increases in HbA1c and fasting serum glucose memory loss, forgetfulness,
- confusion, and
- memory impairment.
Drug interactions of Advicor include drugs that decrease elimination of lovastatin such as erythromycin, ketoconazole, itraconazole, clarithromycin, telithromycin, cyclosporine, nefazodone, boceprevir, telaprevir, voriconazole, and protease inhibitors, because decreased elimination of lovastatin could increase the levels of lovastatin in the body and increase the risk of muscle toxicity from lovastatin.
- Large quantities of grapefruit juice (more than 1 quart daily) increase blood levels of lovastatin and should be avoided.
- Amiodarone, verapamil, diltiazem, danazol, niacin, colchicine, ranolazine, gemfibrozil, and fenofibrate may increase the risk of muscle toxicity when combined with lovastatin.
- Cyclosporine or gemfibrozil should not be combined with lovastatin. Patients taking amiodarone should not exceed 40 mg daily of lovastatin.
- Patients taking verapamil, diltiazem, or danazol should start with 10 mg and should not exceed 20 mg of lovastatin daily.
- Patients taking niacin (greater than or equal to 1 g/day), fenofibrate, or cyclosporine should not take more than 20 mg of lovastatin.
- Lovastatin may increase the effect of warfarin.
- Niacin may increase blood glucose levels in individuals with diabetes and medications for controlling blood glucose may need to be adjusted when niacin is taken by those with diabetes.
- Bile acid sequestrants bind and prevent absorption of niacin. Administration of bile acid sequestrants and niacin should be separated by 4-6 hours.
- Alcohol or hot drinks may increase flushing and itching caused by niacin and should not be used when Advicor is ingested.
- Vitamins and nutritional supplements containing niacin or related compounds will increase adverse effects of niacin and should not be combined with Advicor.
Advicor should not be administered to pregnant women because lovastatin can be harmful to the fetus. Niacin has not been evaluated in pregnant women at doses used for treating levels of cholesterol and triglycerides.
What are the side effects of Advicor (niacin and lovastatin)?
The most common side effects are:
- warm sensation,
- stomach upset,
- muscle pain, and
- tingling in extremities.
Flushing may be reduced by taking 325 mg of aspirin 30 minutes before the niacin and by increasing the dose of niacin slowly.
Drinking hot liquids or alcohol shortly before or after niacin is taken may increase the occurrence of flushing.
Other important side effects include:
- liver test abnormalities,
- kidney failure,
- muscle pain,
- muscle tenderness,
- increases in HbA1c and fasting serum glucose
- memory loss,
- confusion, and
- memory impairment
Lovastatin shares side effects, such as liver and muscle damage associated with all statins. Serious liver damage caused by statins is rare. More often, statins cause abnormalities of liver tests.
Abnormal tests usually return to normal even if a statin is continued, but if the abnormal test value is greater than three times the upper limit of normal, the statin usually is stopped. Liver function tests should be performed at the beginning of treatment then as needed thereafter.
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 lovastatin should contact their health care professional immediately if they develop unexplained muscle pain, weakness, or muscle tenderness.
Statins have been associated with increases in HbA1c and fasting serum glucose levels as are seen in diabetes.
There are also post-marketing reports of
- memory loss,
- confusion, and
- memory impairment.
Symptoms may start 1 day to years after starting treatment and resolve within a median of 3 weeks after stopping the statin.
Advicor (niacin and lovastatin) side effects list for healthcare professionals
- In controlled clinical studies, 40/214 (19%) of patients randomized to Advicor discontinued therapy prior to study completion.
- Of the 214 patients enrolled 18 (8%) discontinued due to flushing.
- In the same controlled studies, 9/94 (10%) of patients randomized to lovastatin and 19/92 (21%) of patients randomized to Niaspan also discontinued treatment prior to study completion secondary to adverse events.
- Flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse events, and occurred in 53% to 83% of patients treated with Advicor.
- Spontaneous reports with Niaspan and clinical studies with Advicor suggest that flushing may also be accompanied by symptoms of dizziness or syncope, tachycardia, palpitations, shortness of breath, sweating, burning sensation/skin burning sensation, chills, and/or edema.
Adverse Reactions Information
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
The adverse reaction information from clinical studies does, however provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
The data described in this section reflect the exposure to Advicor in two double-blind, controlled clinical studies of 400 patients. The population was 28 to 86 years-of-age, 54% male, 85% Caucasian, 9% Black, and 7% Other, and had mixed dyslipidemia.
In addition to flushing, other adverse events occurring in 5% or greater of patients treated with Advicor are shown in Table 10 below.
Table 10: Treatment-Emergent Adverse Events in ≥ 5% of Patients (Events Irrespective of Causality; Data from Controlled, Double-Blind Studies)
|Total Number of Patients||214||92||94|
|Cardiovascular||163 (76%)||66 (72%)||24 (26%)|
|Flushing||152 (71%)||60 (65%)||17 (18%)|
|Body as a Whole||104 (49%)||50 (54%)||42 (45%)|
|Asthenia||10 ( 5%)||6 ( 7%)||5 ( 5%)|
|Flu Syndrome||12 ( 6%)||7 ( 8%)||4 ( 4%)|
|Headache||20 ( 9%)||12 (13%)||5 ( 5%)|
|Infection||43 (20%)||14 (15%)||19 (20%)|
|Pain||18 ( 8%)||3 ( 3%)||9 (10%)|
|Pain, Abdominal||9 ( 4%)||1 ( 1%)||6 ( 6%)|
|Pain, Back||10 ( 5%)||5 ( 5%)||5 ( 5%)|
|Digestive System||51 (24%)||26 (28%)||16 (17%)|
|Diarrhea||13 ( 6%)||8 ( 9%)||2 ( 2%)|
|Dyspepsia||6 ( 3%)||5 ( 5%)||4 ( 4%)|
|Nausea||14 ( 7%)||11 (12%)||2 ( 2%)|
|Vomiting||7 ( 3%)||5 ( 5%)||0|
|Metabolic and Nutrit. System||37 (17%)||18 (20%)||13 (14%)|
|Hyperglycemia||8 ( 4%)||6 ( 7%)||6 ( 6%)|
|Musculoskeletal System||19 ( 9%)||9 (10%)||17 (18%)|
|Myalgia||6 ( 3%)||5 ( 5%)||8 ( 9%)|
|Skin and Appendages||38 (18%)||19 (21%)||11 (12%)|
|Pruritus||14 ( 7%)||7 ( 8%)||3 ( 3%)|
|Rash||11 ( 5%)||11 (12%)||3 ( 3%)|
Note: Percentages are calculated from the total number of patients in each column.
See also the full prescribing information for niacin extended release (Niaspan) and lovastatin products.
The following adverse events have also been reported with niacin, lovastatin, and/or other HMG-CoA reductase inhibitors, but not necessarily with Advicor, either during clinical studies or in routine patient management.
|Body as a Whole:||chest pain; abdominal pain; edema; chills; malaise|
|Cardiovascular:||atrial fibrillation; tachycardia; palpitations, and other cardiac arrhythmias; postural hypotension, orthostasis; hypotension; syncope|
|Eye:||toxic amblyopia; cystoid macular edema; ophthalmoplegia; eye irritation, blurred vision, progression of cataracts|
|Gastrointestinal:||activation of peptic ulcers and peptic ulceration; dyspepsia; vomiting; anorexia; constipation; flatulence, pancreatitis; hepatitis; fatty change in liver; jaundice; and rarely, cirrhosis, fulminant hepatic necrosis, and hepatoma, eructation, fatal and non-fatal hepatic failure|
|Metabolic:||gout, decreased glucose tolerance|
|Musculoskeletal:||muscle cramps; myopathy; rhabdomyolysis; arthralgia, myalgia|
|Nervous:||dizziness; insomnia; dry mouth; paresthesia; anxiety; tremor; vertigo; peripheral neuropathy; psychic disturbances; dysfunction of certain cranial nerves, nervousness, burning sensation/skin burning sensation, peripheral nerve palsy|
|Skin:||hyper-pigmentation; acanthosis nigricans; urticaria; alopecia; dry|
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).
Clinical Laboratory Abnormalities
Elevations in serum transaminases, CPK and fasting glucose, and reductions in phosphorus. Niacin extended-release tablets have been associated with slight elevations in LDH, uric acid, total bilirubin, amylase and creatine kinase. Lovastatin and/or HMG-CoA reductase inhibitors have been associated with elevations in alkaline phosphatase, γ-glutamyl transpeptidase and bilirubin, and thyroid function abnormalities.
Niacin extended-release tablets have been associated with slight reductions in platelet counts and prolongation in PT.
Does Advicor (niacin and lovastatin) cause withdrawal or addiction symptoms?
Drug Abuse And Dependence
Neither niacin nor lovastatin is a narcotic drug. Advicor has no known addiction potential in humans.
What drugs interact with Advicor (niacin and lovastatin)?
Antihypertensive Therapy – Niacin may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension.
Aspirin: Concomitant aspirin may decrease the metabolic clearance of niacin. The clinical relevance of this finding is unclear.
Bile Acid Sequestrants – An in vitro study was carried out investigating the niacin-binding capacity of colestipol and cholestyramine. About 98% of available niacin was bound to colestipol, with 10 to 30% binding to cholestyramine.
These results suggest that 4 to 6 hours, or as great an interval as possible, should elapse between the ingestion of bile acid-binding resins and the administration of Advicor.
Other – Concomitant alcohol or hot drinks may increase the side effects of flushing and pruritus and should be avoided around the time of Advicor ingestion. Vitamins or other nutritional supplements containing large doses of niacin or related compounds such as nicotinamide may potentiate the adverse effects of Advicor.
Lovastatin is metabolized by CYP3A4 but has no CYP3A4 inhibitory activity; therefore it is not expected to affect the plasma concentrations of other drugs metabolized by CYP3A4.
Strong inhibitors of CYP3A4 (e.g., itraconazole, ketoconazole, posaconazole, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, and erythromycin), and large quantities of grapefruit juice ( >1 quart daily) increase the risk of myopathy by reducing the elimination of lovastatin.
In vitro studies have demonstrated that voriconazole inhibits the metabolism of lovastatin. Adjustment of the lovastatin dose may be needed to reduce the risk of myopathy, including rhabdomyolysis, if voriconazole must be used concomitantly with lovastatin.
Interactions With Lipid-Lowering Drugs That Can Cause Myopathy When Given Alone
The risk of myopathy is also increased by the following lipid-lowering drugs that are not strong CYP3A4 inhibitors, but which can cause myopathy when given alone.
Other Drug Interactions
Cyclosporine: The risk of myopathy/rhabdomyolysis is increased by concomitant administration of cyclosporine.
Danazol, Diltiazem, or Verapamil: The risk of myopathy/rhabdomyolysis is increased by concomitant administration of danazol, diltiazem, or verapamil particularly with higher doses of lovastatin.
Amiodarone: The risk of myopathy/rhabdomyolysis is increased when amiodarone is used concomitantly with a closely related member of the HMG-CoA reductase inhibitor class.
Coumarin Anticoagulants – In a small clinical study in which lovastatin was administered to warfarin-treated patients, no effect on PT was detected.
However, another HMG-CoA reductase inhibitor has been found to produce a less than two seconds increase in PT in healthy volunteers receiving low doses of warfarin.
Also, bleeding and/or increased PT have been reported in a few patients taking coumarin anticoagulants concomitantly with lovastatin. It is recommended that in patients taking anticoagulants, PT be determined before starting Advicor and frequently enough during early therapy to insure that no significant alteration of PT occurs.
Once a stable PT has been documented, PT can be monitored at the intervals usually recommended for patients on coumarin anticoagulants. If the dose of Advicor is changed, the same procedure should be repeated.
Colchicine – Cases of myopathy, including rhabdomyolysis, have been reported with lovastatin coadministered with colchicine.
Ranolazine – The risk of myopathy, including rhabdomyolysis, may be increased by concomitant administration of ranolazine.
Propranolol – In normal volunteers, there was no clinically significant pharmacokinetic or pharmacodynamic interaction with concomitant administration of single doses of lovastatin and propranolol.
Digoxin – In patients with hypercholesterolemia, concomitant administration of lovastatin and digoxin resulted in no effect on digoxin plasma concentrations.
Oral Hypoglycemic Agents – In pharmacokinetic studies of lovastatin in hypercholesterolemic, non-insulin dependent diabetic patients, there was no drug interaction with glipizide or with chlorpropamide.
Drug/Laboratory Test Interactions
Niacin may produce false elevations in some fluorometric determinations of plasma or urinary catecholamines. Niacin may also give false-positive reactions with cupric sulfate solution (Benedict's reagent) in urine glucose tests.
Advicor (niacin and lovastatin) is a combination of niacin (vitamin B3) and an HMG-CoA reductase inhibitor (a "statin") used for lowering cholesterol levels in the blood. It reduces blood levels of total cholesterol, low density lipoprotein (LDL) cholesterol, and triglycerides and increases blood levels of high-density lipoprotein (HDL) cholesterol. Common side effects of Advicor include flushing, skin redness, warm sensation, rash, itching, headache, stomach upset, nausea, vomiting, muscle pain, and tingling in extremities. Niacin has not been evaluated in pregnant women at doses used for treating levels of cholesterol and triglycerides. Niacin in Advicor is excreted in breast milk and may cause side effects if ingested by the infant.
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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.