Medication updates – Tramadol, Denosumab and Pregabalin Study

Author: Margaret Gibbs
Category: Medication News
Date: November 28, 2018


The SPC for all brands and products containing tramadol contains information on dependence and treatment discontinuation. Tramadol has partial opioid activity and thus is prone to abuse if used inappropriately. This warning advises using it for the shortest time required for management of pain, then weaning it gradually. We are also reminded that it is metabolised by CYP3A4 and 2D6 so, when used alongside other drugs requiring these enzymes, there may be competition for their breakdown and thus raised levels of tramadol. Those to consider include almost all antidepressants, metoclopramide, haloperidol, omeprazole and oxycodone.


The SPC for denosumab injection has been revised to highlight that new primary malignancy is a common potential adverse effect of treatment when used in patients with benign or malignant neoplasms.

This update is based on an analysis of four RCTs in patients with advanced malignancies involving bone. New primary malignancy was reported in 1.5% of patients treated with denosumab (median exposure of 13.8 months) and 0.9% of patients treated with zoledronic acid (median exposure of 12.9 months). The cumulative incidence at one year was 1.1 % for denosumab and 0.6 % for zoledronic acid.

Care when prescribing pregabalin with opioids

A Canadian study has raised awareness of the risk of opioid-related death in patients who have been prescribed gabapentin in the preceding 120 days. The risk of possible respiratory depression has been acknowledged in SPCs for gabapentin, but this study shows the risk also applies to pregabalin.

The study calls for a revision of the SPCs for pregabalin, based on these findings.

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