Objective: Tramadol is a weak opioid used as a step 2 analgesic, approved in France for moderate to severe pain. After dextropropoxyphene withdrawal, a national pharmacovigilance follow-up of tramadol was decided by the French Drug Agency.
Methods: All Serious Adverse Drug Reactions (SADR) notified with tramadol to the French PharmacoVigilance Centres (CRPV) and pharmaceutical companies between August 1(st), 2010 and July 31(th), 2011 were analyzed.
Results: During the study period, 296 cases of SADR were notified to CRPV and 59 to pharmaceutical companies. Apart from opiate-related SADR, tramadol induced serotoninergic SADR, including seizures or serotoninergic syndromes. Several « unlabelled » SADR were also identified: some of them, like hyponatremia or hypoglycemia, are poorly known by health professionals. Other were never published: peripheral edema or pancreatitis.
Conclusion: This study shows that besides well-known opioid or serotoninergic ADR, tramadol can also induce 2 other relatively unknown ADR: hypoglycemia and hyponatremia.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.2515/therapie/2013021 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Design and analysis of a telemonitoring system for high-risk pregnant women in need of special care or attention.
BMC Pregnancy Childbirth
December 2024
Department of Health Information Technology and Management, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Background: High-risk pregnancies, characterized by underlying health issues or unusual circumstances, pose increased risks to both maternal and neonatal health during pregnancy and childbirth. Global guidelines emphasize the importance of early identification, monitoring, and intervention to mitigate these risks.
Method: We decided to design and implement a telemonitoring system for remotely monitoring and managing pregnancies in women with conditions such as hypertension, diabetes, or high-risk pregnancy.
Serious Adverse Drug Reactions and Safety Signals in Children: A Nationwide Database Study.
Front Pharmacol
August 2020
Pharmacy School, Rio de Janeiro Federal University, Rio de Janeiro, Brazil.
Children are more exposed to inappropriate medicine use and its consequent harms. Spontaneous reporting of suspected Serious Adverse Drug Reactions (SADR) increases knowledge and prevention of pharmacotherapy risk. Disproportionality measures are useful to quantify unexpected safety issues associated with a given drug-event pair (signals of disproportionality).
View Article and Find Full Text PDF["Serious" adverse drug reactions with tramadol: a 2010-2011 pharmacovigilance survey in France].
Therapie
August 2013
Laboratoire de Pharmacologie Médicale et Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, et Centre Midi-Pyrénées d'Évaluation et d'Information sur la Pharmacodépendance-Addictovigilance, Université de Toulouse, Faculté de Médecine, Centre hospitalier universitaire, Toulouse, France.
Objective: Tramadol is a weak opioid used as a step 2 analgesic, approved in France for moderate to severe pain. After dextropropoxyphene withdrawal, a national pharmacovigilance follow-up of tramadol was decided by the French Drug Agency.
Methods: All Serious Adverse Drug Reactions (SADR) notified with tramadol to the French PharmacoVigilance Centres (CRPV) and pharmaceutical companies between August 1(st), 2010 and July 31(th), 2011 were analyzed.
[Not Available].
Therapie
July 2016
Laboratoire de Pharmacologie Médicale et Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, et Centre Midi-Pyrénées d'Évaluation et d'Information sur la Pharmacodépendance-Addictovigilance, Université de Toulouse, Faculté de Médecine, Centre hospitalier universitaire, Toulouse, France.
Objective: Tramadol is a weak opioid used as a step 2 analgesic, approved in France for moderate to severe pain. After dextropropoxyphene withdrawal, a national pharmacovigilance follow-up of tramadol was decided by the French Drug Agency.
Methods: All Serious Adverse Drug Reactions (SADR) notified with tramadol to the French PharmacoVigilance Centres (CRPV) and pharmaceutical companies between August 1(st), 2010 and July 31(th), 2011 were analyzed.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!