Post-marketing surveillance of buprenorphine.
OBJECTIVE
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.
Ray
Rajat
R
National Drug Dependence Treatment Centre, All India Institute Of Medical Sciences, New Delhi, India. rayrajat@hotmail.com
Pal
Hemraj
H
Kumar
Rajesh
R
Maulick
Pallab
P
Mangla
R
R
D000286:Administration, Sublingual; D000328:Adult; D002047:Buprenorphine / Q000008:administration & dosage / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D006801:Humans; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000009:adverse effects*; D009325:Nausea / Q000139:chemically induced; D011358:Product Surveillance, Postmarketing; D011957:Receptors, Opioid / Q000819:agonists*; D012894:Sleep Stages / Q000187:drug effects; D019966:Substance-Related Disorders / Q000188:drug therapy; D013607:Tablets; D014839:Vomiting / Q000139:chemically induced
D009292:Narcotic Antagonists; D011957:Receptors, Opioid; D013607:Tablets; D002047:Buprenorphine