Off-label prescription of fixed-dose combination of tramadol and dexketoprofen in primary health care. Evidence-based or cause for concern?

Abstract Background: The increase of consumption of the fixed-dose combination of tramadol/dexketoprofen in Spain and other countries is noteworthy. The authorised therapeutic indication is symptomatic short-term treatment of moderate to severe acute pain in adult patients.Objective: Describe the pattern of use of tramadol/dexketoprofen in the field of primary health care to examine potential off-label prescribing and warn about possible risks.Methods: A descriptive, cross-sectional and multicenter study carried out between March 2017 and March 2018. Total population were patients covered by the public health service in Catalonia, Spain, with an active prescription of tramadol/dexketoprofen on March 28, 2018. Target population were those patients who were prescribed tramadol/dexketoprofen over 20 day’s treatment.Results: There were 176 patients with active prescription of tramadol/dexketoprofen. All patients (100%) had a treatment duration exceeding 5 days and 72.7% (N=128) exceeding 20 days. The average length of treatment was 224±160.8 days. 35.1% of patients were treated with >2 medicines for pain concomitantly with tramadol/dexketoprofen.Conclusion: Tramadol/dexketoprofen fixed-dose combination in practice was used frequently off labelled according to the product characteristics and the literature reviewed. This study highlights potential harmful or ineffective effects of this combination since no adequate evidence exists about its off-label use.