Post-marketing surveillance of buprenorphine.

PURPOSE: This study was undertaken to evaluate the adverse consequences of recently introduced higher strength (0.4 and 2.0 mg per tablet) buprenorphine in Indian market. Buprenorphine, a partial opiate agonist and antagonist, is an emerging alternative to methadone as an agent for long-term treatment of opiate dependence.

METHODS

The current investigation was conducted through a multi-centric post-marketing surveillance (PMS) study using a structured performa from patients receiving buprenorphine as routine therapy from de-addiction centres. Evaluation included subjective and objective assessments and recording of adverse events.

RESULTS

Of the 5551 observations from ten centres, common subjective symptoms were generalised weakness (48.9%), sense of high (euphoria) (44.5%), muscle aches (39.5%) and relief from pain (37.2%). About 5% observations recorded systolic hypertension. Among 55 subjects where laboratory tests were conducted, 12 showed raised levels of AST ad 9 had elevated ALT. Twelve adverse events reported included seizure, epistaxis, panic attacks, constipation and dyspnoea. Significant relation was seen between duration of use and time since last dose, and total number of subjective symptoms reported.

CONCLUSIONS

Majority of the adverse effects could be understood as either effects related to intoxication or withdrawal from agonists.