Post marketing surveillance of sublingual buprenorphine naloxone combination tablets.

BACKGROUND & OBJECTIVES: A combination of buprenorphine-naloxone (Addnok-N) tablets has been recently introduced in India as treatment for Opioid dependence. This study was undertaken to evaluate the possible adverse consequences following use of the buprenorphine-naloxone tablets through post marketing surveillance.

METHODS: National Drug Dependence Treatment Centre (NDDTC), AIIMS, India, monitored all patients receiving buprenorphine-naloxone combination tablets from the centre over a period of two and half years. Evaluation included subjective and objective side effect checklist, physical examination, and laboratory investigation.

RESULTS: Data was obtained from 1132 observations among 158 patients. Commonly reported medication effects, like muscle aches (44.0%), sleepiness (44.0%), relief from pain (41.3%), etc; are expected in opioid substitution treatment. Laboratory investigations were mostly normal except for liver enzyme abnormalities (52.2% of cases). Eight adverse events were reported in the study. No dangerous event or mortality was reported during the study.