Hepatotoxicity has been reported with most of the nonsteroidal antiinf
lammatory drugs (NSAID). We describe four patients who presented hepat
ic injury after of treatment with Droxicam, a new NSAID prodrug of pir
oxicam. Hepatitis was attribuited to Droxicam because of the absence o
f other etiological factors, temporal relation with drug administratio
n, clinical, laboratory and histological picture and evolution favorab
le after the drug suppression. The hepatic injury was manifested as ch
olestasis and withdrawal of the drug was followed by biochemical and c
linical improvement until the complete normalization in three of the f
our patients. Postmarketing surveillance is necessary in new drugs wit
h unknown hepatotoxicity.