tapentadol and Seizures

Tapentadol is a centrally acting analgesic that has been available for the management of acute and chronic pain in routine clinical practice since 2009.. This is the first integrated descriptive analysis of post-marketing safety data following the use of tapentadol in a broad range of pain conditions relating to the topics overall safety, dose administration above approved dosages, administration during pregnancy, serotonin syndrome, respiratory depression, and convulsion. The data analyzed pertain to spontaneous reports from healthcare and non-healthcare professionals and were put in the context of safety information known from interventional and non-interventional trials.. The first years of routine clinical practice experience with tapentadol have confirmed the tolerability profile that emerged from the clinical trials. Moreover, the reporting of expected side effects such as respiratory depression and convulsion was low and no major risks were identified. The evaluation of available post-marketing data did not confirm the theoretical risk of serotonin syndrome nor did it reveal unexpected side effects with administration of higher than recommended doses.. More than 8 years after its first introduction, the favorable overall safety profile of tapentadol in the treatment of various pain conditions is maintained in the general population.. Grünenthal GmbH.

Topics: Analgesics, Opioid; Chronic Pain; Clinical Trials as Topic; Dose-Response Relationship, Drug; Female; Humans; Pain; Product Surveillance, Postmarketing; Respiratory Insufficiency; Seizures; Serotonin Syndrome; Tapentadol

Topics: Analgesics, Opioid; Humans; Opioid-Related Disorders; Seizures; Tapentadol

Topics: Analgesics, Opioid; Delayed-Action Preparations; Humans; Injections, Intravenous; Seizures; Tapentadol

Tapentadol (TAP) and tramadol (TRA) provide pain relief through similar monoaminergic and opioid agonist properties.. To compare clinical effects and medical outcomes between TAP and TRA exposures reported to the National Poison Data System of the American Association of Poison Control Centers.. A retrospective cohort study was conducted analyzing national data for single medication TAP or TRA cases reported from June 2009 through December 2011. Case outcomes, dichotomized as severe versus mild; clinical effects; and use of naloxone were compared.. There were 217 TAP and 8566 TRA cases. Significantly more severe outcomes were associated with TAP exposures for an all-age comparison (relative risk [RR] = 1.24; 95% CI = 1.04-1.48), and for the <6-year-old age group (RR = 5.76; 95% CI = 2.20-15.11). Patients with TAP exposures had significantly greater risk of respiratory depression (RR = 5.56; 95% CI = 3.50-8.81), coma (RR = 4.16; 95% CI = 2.33-7.42), drowsiness/lethargy (RR = 1.38; 95% CI = 1.15-1.66), slurred speech (RR = 3.51; 95% CI = 1.98-6.23), hallucination/delusion (RR = 7.25; 95% CI = 3.61-14.57), confusion (RR = 2.54; 95% CI = 1.56-4.13) and use of naloxone (RR = 3.80; 95% CI = 2.96-4.88). TRA exposures had significantly greater risk of seizures (RR = 7.94; 95% CI = 2.99-20.91) and vomiting (RR = 1.96; 95% CI = 1.07-3.60).. TAP was associated with significantly more toxic clinical effects and severe outcomes consistent with an opioid agonist. TRA was associated with significantly higher rates of seizures and vomiting.

Topics: Adolescent; Adult; Adverse Drug Reaction Reporting Systems; Aged; Aged, 80 and over; Analgesics, Opioid; Child; Child, Preschool; Drug Overdose; Female; Humans; Infant; Male; Middle Aged; Phenols; Poison Control Centers; Retrospective Studies; Risk; Seizures; Tapentadol; Tramadol; Vomiting; Young Adult