Reporting rate of adverse drug reactions to the French pharmacovigilance system with three step 2 analgesic drugs: dextropropoxyphene, tramadol and codeine (in combination with paracetamol)

Tavassoli, Néda; Lapeyre‐Mestre, Maryse; Sommet, Agnès; Montastruc, Jean‐Louis

doi:10.1111/j.1365-2125.2009.03472.x

Cited by 33 publications

(24 citation statements)

References 11 publications

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“…These results are in accordance with those of Tavassoli et al . who found a similar reporting rate of hypoglycaemia with DXP (0.8/100 000 person‐years) and TRM (0.6/100 000 person‐years) . However, this study provided no details on the characteristics of hypoglycaemia.…”

Section: Discussionmentioning

confidence: 48%

“…TRM acts through the activation of μ‐opioid receptors and in addition inhibits the central re‐uptake of serotonin and norepinephrine, which are both involved in central nociceptive transmission . The most frequent adverse effects associated with TRM include gastrointestinal disorders (nausea, vomiting and constipation) and neuropsychiatric effects (sedation, confusion, dizziness, anxiety and sweating) .…”

Section: Introductionmentioning

confidence: 99%

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Tramadol and hypoglycaemia: comparison with other step 2 analgesic drugs

Bourne¹,

Gouraud²,

Daveluy

et al. 2013

Brit J Clinical Pharma

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AIMSThe risk of hypoglycaemia with tramadol (TRM) is not well described. Our aim was to analyze spontaneous reports of hypoglycaemia registered in the French Pharmacovigilance database and to compare these data with two other step-2 analgesic drugs. METHODSCases of hypoglycaemia associated with TRM, dextropropoxyphene (DXP) and codeine (COD) recorded between 1997 and November 2010 in the French pharmacovigilance database were compared. RESULTSSeventy-two cases of hypoglycaemia associated with DXP and 43 with TRM were retained for evaluation (the single case reported with COD was not further considered). Most patients were elderly people with no significant difference in age between DXP-and TRM-treated patients (71.2 Ϯ 21 vs. 69.4 Ϯ 22.5 years). Hypoglycaemia occurred after a median of 4 and 5 days with DXP and TRM treatment, respectively. The mean lowest serum glucose concentration was 2.1 Ϯ 0.9 mmol l -1 in the DXP group compared with 2.5 Ϯ 1 mmol l -1 in the TRM group (P = 0.072). At least, one risk factor of hypoglycaemia was found in most patients, with no significant difference between groups (58.3% in the DXP group and 58.1% in the TRM group). In particular, 31.9% patients from the DXP group had diabetes compared with 41.8 % from the TRM group (P = 0.28) and 18% of DXP patients had renal insufficiency compared with 16.3% of TRM patients (P = 0.8). CONCLUSIONSOur study confirms that TRM is associated with the occurrence of hypoglycaemia in elderly or predisposed patients, with characteristics similar to those previously reported with DXP. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Whereas dextropropoxyphene (DXP) has been recognized as a possible cause of hypoglycaemia, only isolated reports have described a similar adverse effect with tramadol (TRM).• To the best of our knowledge, there is no large study comparing the occurrence of hypoglycaemia in patients treated with these step 2 analgesics. WHAT THIS STUDY ADDS• The aim of this study was to describe spontaneous reports of hypoglycaemia associated with TRM and to compare these data with that of DXP-induced hypoglycaemia.• The results show that the characteristics of hypoglycaemia in tramadol users are very similar to those described with DXP, with old age, diabetes and renal insufficiency as the main risk factors.• Physicians and patients should be warned of this potential adverse effect.

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Section: Discussionmentioning

confidence: 48%

Section: Introductionmentioning

confidence: 99%

Tramadol and hypoglycaemia: comparison with other step 2 analgesic drugs

Bourne¹,

Gouraud²,

Daveluy

et al. 2013

Brit J Clinical Pharma

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“…First, underreporting of ADRs to pharmacovigilance system is usual and may reach 90% of cases 14. Nonetheless, underreporting rate was shown to be similar for several drugs from the same therapeutic class,15 and this methodology was further validated by our group with step 2 analgesic drugs16 or for drugs causing dilated cardiomyopathy 17. Second, a number of important factors, such as patients' diagnosis, age, related comorbidities or comedications, age at onset of PD, DAs doses, or changes in reporting patterns during the 24‐year studied time span, could have introduced some bias in the results.…”

Section: Discussionmentioning

confidence: 81%

Adverse drug reactions to dopamine agonists: A comparative study in the french pharmacovigilance database

et al. 2010

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Pharmacodynamical differences between dopamine agonists (DAs) suggest differences in their adverse drug reactions (ADRs) profile. In this study, frequencies of ADR to DAs or levodopa reports in the French Pharmacovigilance Database were explored. Reports occurring between January 1, 1984 and December 31, 2008 were selected (2,189 for DAs and 1,315 for levodopa). The numbers of ADRs by system organ class were compared using ropinirole as a reference. Diurnal somnolence was less frequently reported with all DAs when compared with ropinirole (P < 0.001). Impulse control disorders (ICDs) were more frequently reported with pramipexole (P < 0.001). Significant difference was found among DAs in the frequency of confusion or disorientation (P < 0.001), nausea and vomiting (P < 0.05), or edemas (P < 0.001). No difference among DAs was observed in the frequency of hallucination or arterial hypotension ADR reports (P = 0.3 and P = 0.1). Pleural effusions were more frequently reported with pergolide or bromocriptine (P < 0.001). Somnolence or ICD reports were less frequent with levodopa, whereas confusion was more frequently reported. In summary, our data show significant differences in the kind of ADRs reported for each DA.

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“…ADRs possibly related to substance use disorders constitute one of the most frequently reported ADRs of tramadol (269). Discrepancies in study results between studies may be explained by differences between countries in the features of the pharmacovigilance system, legislation, prescription rates, treatment recommendations, definitions of dependence, and the investigated study period.…”

Section: Specific Drug Classes N (%)mentioning

confidence: 97%

Psychoactive prescription drug use disorders, misuse and abuse : Pharmacoepidemiological aspects

Tjäderborn

2016

Linköping University Medical Dissertations

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Background: There is a widespread and increasing use of psychoactive prescription drugs, such as opioid analgesics, anxiolytics, hypnotics and anti-epileptics, but their use is associated with a risk of drug use disorder, misuse and abuse. Today, these are globally recognised and emerging public health concerns. Aim:The aim of this thesis is to estimate the occurrence and prevalence of psychoactive prescription drug use disorders, misuse and abuse, and to investigate the association with some potential risk factors. Methods:A study using register data from forensic cause of death investigations analysed and described cases of fatal unintentional intoxications with tramadol (Study I). Based on register data on spontaneously reported adverse drug reactions (ADRs) reported cases of tramadol dependence were scrutinized and summarised (Study II). In a study in suspected drug-impaired drivers with a toxicology analysis confirming intake of tramadol, diazepam, flunitrazepam, zolpidem and zopiclone, the prevalence of non-prescribed use was assessed and associated factors were investigated (Study III). From a national cohort of patients initiating prescribed treatment with pregabalin, identified using data on prescription fills, a study investigated longitudinal utilisation patterns during five years with regards to use above the maximum approved daily dose (MAD) of the drug, and factors associated with the utilisation patterns (Study IV).Results: In the first study, 17 cases of unintentional intoxications were identified, in which tramadol was judged to have caused or contributed to the death. Of the deceased, more were men, the median age was 44 years and the majority used multiple psychoactive substances (prescription drugs, alcohol and/or illicit drugs). In the second study, 104 spontaneously vi reported cases of possible or probable tramadol dependence were identified, of which more concerned women. The median age in these cases was 45 years and in about a third of cases the person had a history of substance abuse and in 40% of cases there was documented history of psychoactive medication use. Severe addiction was reported. In the third study, more than half of the individuals suspected of drug-impaired driving used the drug without a recent prescription.Non prescribed use was most frequent in users of benzodiazepines and of tramadol compared to users of zolpidem or zopiclone, and was more likely in younger individuals and in multiplesubstance users and less likely in individuals with a recent prescription for another psychoactive medication. In the last paper, five longitudinal utilisation patterns were found in pregabalin users, with two patterns associated with a particularly high risk of use of doses above the maximum approved daily dose. The highest risk of use of daily doses above the MAD over time was associated with male sex, younger age, non-urban residency, and a recent prescribed treatment with an antiepileptic or opioid analgesic drug. Conclusions

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Reporting rate of adverse drug reactions to the French pharmacovigilance system with three step 2 analgesic drugs: dextropropoxyphene, tramadol and codeine (in combination with paracetamol)

Cited by 33 publications

References 11 publications

Tramadol and hypoglycaemia: comparison with other step 2 analgesic drugs

Tramadol and hypoglycaemia: comparison with other step 2 analgesic drugs

Adverse drug reactions to dopamine agonists: A comparative study in the french pharmacovigilance database

Psychoactive prescription drug use disorders, misuse and abuse : Pharmacoepidemiological aspects

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