TM Owner AbbVie
Simcor 500mg/20mg Tablet
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Indications & Clinical Uses
- Simcor's FDA approval was formally withdrawn by the US Food and Drug Administration effective 18 April 2016, after AbbVie requested withdrawal and outcome trials found no added cardiovascular benefit from combining niacin with statin therapy; it is illegal to manufacture, import or dispense Simcor in the United States since that date, and it is not a currently approved medicine in any major market.
- When it was marketed, Simcor (niacin extended-release 500-1000 mg / simvastatin 20-40 mg) combined extended-release niacin with simvastatin, a combination lipid-lowering tablet, to lower total cholesterol, LDL-cholesterol, apolipoprotein B, non-HDL-cholesterol and triglycerides, and to raise HDL-cholesterol, in adults with primary hyperlipidaemia or mixed dyslipidaemia not adequately controlled on either component alone, taken once daily at bedtime with a low-fat snack.
- This content is drawn from the last FDA-approved label for historical and safety-recognition purposes only and must not be read as an offer to supply, prescribe or import Simcor.
Side Effects
- Historically, the most common Simcor side effect was flushing (warmth, redness, itching or tingling of the skin), reported in up to about 59% of patients and the leading reason for stopping treatment; taking aspirin or another NSAID 30 minutes beforehand and avoiding alcohol, hot drinks and spicy food around dosing reduced it.
- Other common effects included headache, back pain, diarrhoea, nausea and itching.
- No boxed warning appeared on Simcor's US label, but the simvastatin component carried a well-recognised risk of myopathy and, rarely, rhabdomyolysis with kidney failure, more likely at higher doses and in older patients, women, and those with hypothyroidism or renal impairment.
- Because Simcor is withdrawn and no longer available, this information is retained only so patients previously prescribed it can recognise past adverse effects; anyone with remaining stock should contact their healthcare provider about switching to an approved alternative.
Precautions & Warnings
- Simcor is no longer an approved or legally marketable medicine in the United States, so no patient should start it; this section describes the precautions that applied under the withdrawn label.
- It was contraindicated in active liver disease or unexplained persistent transaminase elevations, active peptic ulcer disease or arterial bleeding, and in pregnancy and breastfeeding.
- Liver function tests were checked before and during treatment because of the combined hepatotoxicity risk of niacin and simvastatin.
- Myopathy risk factors, including advanced age, female sex, renal impairment and uncontrolled hypothyroidism, required caution, and treatment was stopped immediately if muscle pain, tenderness or weakness developed with raised creatine kinase.
- Blood glucose was monitored because niacin can worsen glycaemic control in diabetes.
- Anyone with remaining Simcor tablets should not continue taking them and should seek an approved substitute from their healthcare provider.
Avoid Interactions
- Because Simcor is withdrawn, this is historical information only.
- The combination was contraindicated with strong CYP3A4 inhibitors (itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors), gemfibrozil, ciclosporin and danazol, which sharply raised simvastatin levels and myopathy risk, and doses above 1000/20 mg daily were avoided with amiodarone, amlodipine, verapamil, diltiazem or ranolazine.
- Other fibrates were generally avoided in combination, and grapefruit juice above about one quart (roughly one litre) daily was discouraged.
- Coumarin anticoagulants such as warfarin required closer monitoring of prothrombin time/INR, and colchicine was used cautiously because of a reported myopathy interaction.
- Anyone who still has Simcor tablets and takes any of these medicines should not resume the drug and should instead discuss lipid management with their healthcare provider.
References
Frequently Asked Questions
No. The FDA formally withdrew Simcor's approval on 18 April 2016 after AbbVie requested withdrawal and outcome trials showed no cardiovascular benefit from adding niacin to a statin. Simcor (niacin/simvastatin) can no longer be legally manufactured, imported or dispensed in the United States.
Simcor combined extended-release niacin with simvastatin to lower LDL cholesterol, triglycerides and total cholesterol, and raise HDL cholesterol, in adults whose lipids were not controlled by one drug alone. It was taken once daily at bedtime with a low-fat snack before its 2016 withdrawal.
The most common Simcor side effect was flushing, warmth or redness of the skin, affecting up to 59% of patients; taking aspirin beforehand often reduced it. The simvastatin component also carried a risk of muscle pain (myopathy) and, rarely, serious muscle breakdown (rhabdomyolysis).
Do not take them. Simcor's US approval was formally revoked in 2016, and it is not legally supplied anywhere it was previously sold. Contact your healthcare provider to discuss an approved cholesterol-lowering alternative and how to safely dispose of any remaining tablets.
Yes. Simcor was contraindicated with gemfibrozil and other fibrates, and with strong CYP3A4 inhibitors such as itraconazole and clarithromycin, because these sharply raised simvastatin levels and myopathy risk. Grapefruit juice over about one litre a day was also discouraged, and warfarin needed closer INR monitoring.
Both. AbbVie requested the withdrawal, but the FDA independently determined Simcor's benefits no longer outweighed its risks and formally withdrew approval effective 18 April 2016, the same notice that withdrew Advicor. This is a regulatory revocation, not just a business decision to stop selling.
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