No conflict of interest was declared.
Post-marketing surveillance of buprenorphine†
Article first published online: 14 MAY 2004
Copyright © 2004 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 13, Issue 9, pages 615–619, September 2004
How to Cite
Ray, R., Pal, H., Kumar, R., Maulick, P. and Mangla, R. (2004), Post-marketing surveillance of buprenorphine. Pharmacoepidem. Drug Safe., 13: 615–619. doi: 10.1002/pds.975
- Issue published online: 7 SEP 2004
- Article first published online: 14 MAY 2004
- Manuscript Accepted: 25 MAR 2004
- Manuscript Revised: 16 FEB 2004
- Manuscript Received: 8 APR 2003
- RUSAN PHARMA Limited, India
- post-marketing surveillance;
- adverse effects
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.
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.
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.
Majority of the adverse effects could be understood as either effects related to intoxication or withdrawal from agonists. Copyright © 2004 John Wiley & Sons, Ltd.