March 1, 2012
FDA has recommended changes to the lovastatin product label. The lovastatin label includes new information about drug interactions that may increase the risk of serious muscle damage, which forms the basis for new contraindications and dose limitations. All doses of lovastatin are now contraindicated for use in combination with strong CYP3A4 inhibitors including boceprevir, clarithromycin, erythromycin, HIV protease inhibitors, itraconazole, ketoconazole, nefazodone, posaconazole, telaprevir, and telithromycin. FDA recommends avoiding concomitant use of lovastatin with cyclosporine or gemfibrozil. In addition, limit the maximum lovastatin dose in patients taking the following concomitant medications:
- Danazol: do not exceed lovastatin 20 mg daily
- Diltiazem: do not exceed lovastatin 20 mg daily
- Verapamil: do not exceed lovastatin 20 mg daily
- Amiodarone: do not exceed lovastatin 40 mg daily
Use additional caution when evaluating drug interaction risk in patients treated with lovastatin and consider other patient-specific risk factors for myopathy. As of February 2012, these new drug interaction warnings have not yet been added to many drug information references, and may not yet be flagged in drug interaction software. Additionally, the product label only provides a partial list of CYP3A4 inhibitors which are contraindicated for use with lovastatin. The product labeling does not specifically list other drugs that many clinicians may consider to be strong CYP3A4 inhibitors, such as isoniazid, other azole antifungals (eg, fluconazole, miconazole, voriconazole), and many tyrosine kinase inhibitors (eg, dasatinib, imatinib, lapatinib). However, avoid concomitant use of any strong CYP3A4 inhibitor with lovastatin. Consider using lower lovastatin doses (10 or 20 mg/day) in patients receiving concomitant therapy with moderate CYP3A4 inhibitors (eg, cilostazol, fluoxetine, nicardipine, nilotinib, pazopanib). Drug information references may differ in how they classify magnitude of CYP3A4 inhibitory effect of various drugs; use clinical judgment and additional caution when recommendations differ in the published references.
Report any related adverse events to FDA’s MedWatch Adverse Event Reporting program online: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
Additional information is available at the following links:
- MedWatch Alert:
- FDA Drug Safety Communication
- FDA Consumer Update
March 1, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.