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An independent assessment of MEDWatch reporting for abuse/dependence and withdrawal from Ultram (tramadol hydrochloride). 2003

George E Woody, and Edward C Senay, and Anne Geller, and Edgar H Adams, and James A Inciardi, and Sidney Schnoll, and Alvaro Muñoz, and Theodore J Cicero
Treatment Research Institute, School of Medicine, Philadelphia Va/University of Pennsylvania, 600 Public Ledger Building, 150 South Independence Mall (W), Philadelphia, PA 19106 3475, USA. woody@tresearch.org

OBJECTIVE Assess the validity of medical products reporting program (MEDWatch) reports of abuse/dependence and withdrawal associated with Ultram (tramadol). METHODS Reports of possible abuse/dependence or withdrawal associated with Ultram during 13 quarters following launch were spontaneously reported to the manufacturer Ortho-McNeil Pharmaceutical (OMP) and also solicited from 255 NIDA grantees and addiction treatment professionals by an Independent Steering Committee (ISC). Reports were classified by the ISC using DSM-IV criteria, by the Drug Safety and Surveillance (DSS) units of Robert Wood Johnson Pharmaceutical Research Institute (PRI) using World Health Organization Adverse Reaction Terms (WHOART) terms, and reported to the food and drug administration (FDA) via MEDWatch. Rates of abuse/dependence and withdrawal per 100000 persons exposed were calculated separately for classifications made by the PRI and the ISC, and confidence intervals calculated to determine the degree to which they agreed. RESULTS For 681 reports submitted to PRI, confidence intervals of ISC ratings contained PRI ratings 12 of 13 times for abuse/dependence, and 12 of 13 times for withdrawal. For 242 reports submitted to the ISC, confidence intervals of ISC ratings contained PRI ratings 10 of 13 times for abuse/dependence, and 12 of 13 times for withdrawal. Proactive surveillance increased the total number of cases of abuse/dependence but not withdrawal. Many cases of withdrawal without signs or symptoms of abuse/dependence were identified. CONCLUSIONS There was good/excellent concordance between MEDWatch and ISC classifications. Proactive surveillance increased cases of abuse/dependence but not withdrawal. Withdrawal with no signs or symptoms of dependence was common. More use of proactive surveillance is likely to improve assessments of public health risks associated with adverse events.

UI MeSH Term Description Entries
D011634 Public Health Branch of medicine concerned with the prevention and control of disease and disability, and the promotion of physical and mental health of the population on the international, national, state, or municipal level. Community Health,Environment, Preventive Medicine & Public Health,Environment, Preventive Medicine and Public Health,Health, Community,Health, Public
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000701 Analgesics, Opioid Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. Opioid,Opioid Analgesic,Opioid Analgesics,Opioids,Full Opioid Agonists,Opioid Full Agonists,Opioid Mixed Agonist-Antagonists,Opioid Partial Agonists,Partial Opioid Agonists,Agonist-Antagonists, Opioid Mixed,Agonists, Full Opioid,Agonists, Opioid Full,Agonists, Opioid Partial,Agonists, Partial Opioid,Analgesic, Opioid,Full Agonists, Opioid,Mixed Agonist-Antagonists, Opioid,Opioid Agonists, Full,Opioid Agonists, Partial,Opioid Mixed Agonist Antagonists,Partial Agonists, Opioid
D001330 Electronic Data Processing Applications that store and process large quantities of data. Automatic Data Processing,Bar Codes,Computer Data Processing,Data Processing, Automatic,Information Processing, Automatic,Optical Readers,Information Processing,Automatic Information Processing,Bar Code,Codes, Bar,Data Processing, Computer,Data Processing, Electronic,Optical Reader,Processing, Automatic Data,Processing, Automatic Information,Processing, Computer Data,Processing, Electronic Data,Processing, Information
D013375 Substance Withdrawal Syndrome Physiological and psychological symptoms associated with withdrawal from the use of a drug after prolonged administration or habituation. The concept includes withdrawal from smoking or drinking, as well as withdrawal from an administered drug. Drug Withdrawal Symptoms,Withdrawal Symptoms,Drug Withdrawal Symptom,Substance Withdrawal Syndromes,Symptom, Drug Withdrawal,Symptom, Withdrawal,Symptoms, Drug Withdrawal,Symptoms, Withdrawal,Syndrome, Substance Withdrawal,Syndromes, Substance Withdrawal,Withdrawal Symptom,Withdrawal Symptom, Drug,Withdrawal Symptoms, Drug,Withdrawal Syndrome, Substance,Withdrawal Syndromes, Substance
D014147 Tramadol A narcotic analgesic proposed for severe pain. It may be habituating. Adolonta,Amadol,Biodalgic,Biokanol,Contramal,Jutadol,K-315,MTW-Tramadol,Nobligan,Prontofort,Ranitidin 1A Pharma,Takadol,Theradol,Tiral,Topalgic,Tradol,Tradol-Puren,Tradonal,Tralgiol,Trama 1A Pharma,Trama AbZ,Trama KD,Trama-Dorsch,Tramabeta,Tramadin,Tramadoc,Tramadol 1A,Tramadol AL,Tramadol Asta Medica,Tramadol Basics,Tramadol Bayvit,Tramadol Bexal,Tramadol Cinfa,Tramadol Edigen,Tramadol Heumann,Tramadol Hydrochloride,Tramadol Kern,Tramadol Lichtenstein,Tramadol Lindo,Tramadol Mabo,Tramadol Normon,Tramadol PB,Tramadol Ratiopharm,Tramadol Stada,Tramadol acis,Tramadol-Dolgit,Tramadol-Hameln,Tramadol-ratiopharm,Tramadolor,Tramadura,Tramagetic,Tramagit,Tramake,Tramal,Tramex,Tramundin,Trasedal,Ultram,Xymel 50,Zamudol,Zumalgic,Zydol,Zytram,K 315,K315,MTW Tramadol,MTWTramadol,Tradol Puren,TradolPuren,Trama Dorsch,TramaDorsch,Tramadol Dolgit,Tramadol Hameln,TramadolDolgit,TramadolHameln,Tramadolratiopharm
D014481 United States A country in NORTH AMERICA between CANADA and MEXICO.
D014486 United States Food and Drug Administration An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc. Food and Drug Administration (U.S.),USFDA,Food and Drug Administration,United States Food, Drug Administration
D014944 World Health Organization A specialized agency of the United Nations designed as a coordinating authority on international health work; its aim is to promote the attainment of the highest possible level of health by all peoples. Organization, World Health,WHO
D016365 Liability, Legal Accountability and responsibility to another, enforceable by civil or criminal sanctions. Institutional Liability,Personal Liability,Professional Liability,Legal Liability,Medical Liability,Torts,Institutional Liabilities,Legal Liabilities,Liabilities, Institutional,Liabilities, Legal,Liabilities, Medical,Liabilities, Personal,Liabilities, Professional,Liability, Institutional,Liability, Medical,Liability, Personal,Liability, Professional,Medical Liabilities,Personal Liabilities,Professional Liabilities,Tort

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