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LIPITOR safety information
IMPORTANT SAFETY INFORMATION
LIPITOR® (atorvastatin calcium) tablets are contraindicated in patients with a known hypersensitivity to any component of this product; in patients with active liver disease or unexplained persistent elevations of hepatic transaminases; in women who are or may become pregnant or who are breastfeeding. Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment, and to inform their healthcare provider of a known or suspected pregnancy.
Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with LIPITOR® (atorvastatin calcium) tablets and other statins. Tell patients to promptly report muscle pain, tenderness, or weakness. Predisposing factors include advanced age (≥65), uncontrolled hypothyroidism, and renal impairment. Patients with a history of renal impairment merit closer monitoring. In cases of myopathy or rhabdomyolysis, therapy should be temporarily withheld or discontinued.
The concomitant use of higher doses of LIPITOR® (atorvastatin calcium) tablets with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (eg, clarithromycin, itraconazole, and HIV protease inhibitors) increases the risk of myopathy/rhabdomyolysis. Lower doses of LIPITOR should be considered. Physicians should carefully monitor patients for signs or symptoms of myopathy early during therapy and when titrating the dose of either drug.
It is recommended that liver function tests be performed prior to the initiation of therapy and repeated as clinically indicated thereafter.
Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LIPITOR® (atorvastatin calcium) tablets.
In a post hoc analysis of the SPARCL study in patients without CHD who had a stroke or TIA within the preceding 6 months, a higher incidence of hemorrhagic stroke was seen in the LIPITOR® 80 mg (atorvastatin calcium) tablets group compared with placebo (2.3% vs 1.4%). Some baseline characteristics, including hemorrhagic and lacunar stroke on study entry, were associated with a higher incidence of hemorrhagic stroke in the LIPITOR group.
The most commonly reported adverse reactions with LIPITOR® (atorvastatin calcium) tablets in
2013 ACC/AHA Guidelines
Broader focus on risk of atherosclerotic cardiovascular disease (ASCVD), which includes stroke, compared with coronary-specific ATP III1,2
Appropriate intensity of statin therapy in those most likely to benefit, rather than LDL-C or non-HDL-C targets, is the recommended treatment target.
- High-intensity statin is recommended for most patients in 4 statin benefit groups.
Focus on global risk assessment for primary prevention
- Specific risk factor counting for risk assessment or the use of randomized controlled trial (RCT) risk factor inclusion criteria to determine statin eligibility is not required.
- Estimation of 10-year risk of ASCVD (CHD and stroke) using Pooled Cohort Equations, rather than CHD alone.
The 4 statin benefit groups
1. Stone NJ, Robinson J, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(25 Pt B):2889-2934. 2. National Cholesterol Education Program. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III): Final Report. Bethesda, MD: National Heart, Lung, and Blood Institute; 2002. NIH publication 02-5215.