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U.S. Department of Health and Human Services

Safety

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Livalo (pitavastatin) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

 

October 2013

Summary View

WARNINGS AND PRECAUTIONS

  • Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors coadministered with colchicine, and caution should be exercised when prescribing LIVALO with colchicine

DRUG INTERACTIONS

Colchicine
  • Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors coadministered with colchicine, and caution should be exercised when prescribing LIVALO with colchicine. 

 

February 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Liver Enzyme Abnormalities
  • There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including pitavastatin. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with Livalo, promptly interrupt therapy. If an alternate etiology is not found do not restart Livalo.
Endocrine Function
  • Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including Livalo.
 

ADVERSE REACTIONS

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Livalo. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions associated with Livalo therapy reported since market introduction, regardless of causality assessment, include the following:

  • abdominal discomfort, abdominal pain, dyspepsia, nausea, asthenia, fatigue, malaise, hepatitis, jaundice, fatal and nonfatal hepatic failure, dizziness, hypoesthesia, insomnia, depression, interstitial lung disease, erectile dysfunction and muscle spasms.
  • 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

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