http://www.fda.gov/medwatch/safety/2000/jun00.htm
SERZONE (nefazodone) Tablets
[June 1, 2000: Bristol-Myers Squibb]
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS: [Note: These
changes appear in the 2000 PDR] "pimozide" is included with
"terfenidine, astemizole, cisapride" regarding interactions.
PRECAUTIONS: Drug Interactions: [Not appearing in 1999 PDR; extensively revised
in the 2000 PDR] Revisions incorporated in the following paragraph - "There
have been reports of increased blood concentrations of cyclosporine and
tacrolimus into toxic ranges when patients received these drugs concomitantly
with Serzone. Both cyclosporine and tacrolimus are substrates of CYP3A4, and
nefazodone is known to inhibit this enzyme. If either cyclosporine or
tacrolimus is administered with Serzone, blood concentrations of the
immunosuppressive agent should be monitored and dosage adjusted
accordingly."
ADVERSE REACTIONS: Postintroduction Clinical Experience: [Appearing in 2000
PDR] New last sentence (paragraph) - "Rare reports of liver necrosis and
liver failure, in some cases leading to liver transplantation and/or
death."