Label Changes for:

Lipitor (atorvastatin calcium) Tablets

February 2012

Changes have been made to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2009 and February 2012

 

February 2012 

 

WARNINGS AND PRECAUTIONS

Skeletal Muscle
  • The risk of myopathy during treatment with drugs in this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, clarithromycin, the hepatitis C protease inhibitor telaprevir, combinations of HIV protease inhibitors, including saquinavir plus ritonavir, lopinavir plus ritonavir, tipranavir plus ritonavir, darunavir plus ritonavir, osamprenavir, and fosamprenavir plus ritonavir, niacin, or azole antifungals. Physicians considering combined therapy with Lipitor nd fibric acid erivatives, erythromycin, clarithromycin, a combination of saquinavir plus ritonavir, lopinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, azole antifungals,…

Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis (table)

  • Cyclosporine, HIV protease inhibitors (tipranavir plus ritonavir), hepatitis C protease inhibitor (telaprevir): Avoid atorvastatin
  • HIV protease inhibitor (lopinavir plus ritonavir): Use with caution and lowest dose necessary…

 

Liver Dysfunction
  • It is recommended that liver enzyme tests be obtained prior to initiating therapy with Lipitor and repeated as clinically indicated. There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including atorvastatin. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with Lipitor, promptly interrupt therapy. If an alternate etiology is not found, do not restart Lipitor.
Endocrine Function
  • Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including Lipitor.

 

ADVERSE REACTIONS

Postmarketing Experience
  • Adverse reactions associated with Lipitor therapy reported since market introduction, that are not listed above, regardless of causality assessment, include the following: anaphylaxis, angioneurotic edema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), rhabdomyolysis, fatigue, tendon rupture, fatal and non-fatal hepatic failure, dizziness, depression, peripheral neuropathy, and pancreatitis.
  • 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).

 

DRUG INTERACTIONS

Combination of Protease Inhibitors:
  • Atorvastatin AUC was significantly increased with concomitant administration of Lipitor with several combinations of HIV protease inhibitors, as well as with the hepatitis C protease inhibitor telaprevir, compared to that of Lipitor alone. Therefore, in patients taking the HIV protease inhibitor tipranavir plus ritonavir, or the hepatitis C protease inhibitor telaprevir, concomitant use of Lipitor should be avoided. In patients taking the HIV protease inhibitor lopinavir plus ritonavir, caution should be used when prescribing Lipitor and the lowest dose necessary should be used. In patients taking the HIV protease inhibitors saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, the dose of Lipitor should not exceed 20 mg and should be used with caution.

Cyclosporine:

  • The co-administration of Lipitor with cyclosporine should be avoided].

Gemfibrozil:

  • Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are co-administered with gemfibrozil, concomitant administration of Lipitor with gemfibrozil should be avoided.

Other Fibrates:

  • Because it is known that the risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concurrent administration of other fibrates, Lipitor should be administered with caution when used concomitantly with gemfibrozil or other fibrates [see Warnings and Precautions].

Niacin:

  • The risk of skeletal muscle effects may be enhanced when Lipitor is used in combination with niacin; a reduction in Lipitor dosage should be considered in this setting [see Warnings and Precautions].

Colchicine:

  • Cases of myopathy, including rhabdomyolysis, have been reported with atorvastatin co-administered with colchicine, and caution should be exercised when prescribing atorvastatin with colchicine.

 

PATIENT COUNSELING INFORMATION

Liver Enzymes
  • It is recommended that liver enzyme tests be performed before the initiation of Lipitor and if signs or symptoms of liver injury occur. All patients treated with Lipitor should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.

 

PATIENT INFORMATION

What are the Possible Side Effects of Lipitor?
  • Liver problems --- Your doctor should do blood tests to check your liver before you start taking Lipitor, and if you have symptoms of liver problems while you take Lipitor. Call your doctor right away if you have the following symptoms of liver problems: feel tired or weak, loss of appetite,upper belly pain, dark amber colored urine,yellowing of your skin or the whites of your eyes What are the Possible Side Effects of Lipitor? The following additional side effects have been reported with Lipitor: --- tiredness, tendon problems, memory loss, and confusion.

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


 

March 2009  

 

Sections Modified

ADVERSE REACTIONS

  • Postintroduction Reports
    • hepatic failure

 

 

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