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On April 6, 2009, the FDA approved a new label for lopinavir/ritonavir (Kaletra) that reflects the drug’s potential for cardiac conduction system abnormalities.
Data show that lopinavir/r prolongs the PR interval in some patients. In addition, cases have been reported of second- and third-degree atrioventricular block, QT interval prolongation, and torsades de pointes, although a causal link has not been established for the latter two disturbances. No formal evaluation has been conducted on the coadministration of lopinavir/r with other drugs that prolong the PR interval, such as calcium-channel blockers, beta blockers, digoxin, and atazanavir.
Based on this information, the new label recommends:
Exercising caution when prescribing lopinavir/r…