An investigation into drug products withdrawn from the EU market between 2002 and 2011 for safety reasons and the evidence used to support the decision-making

BMJ Open

Volumn 4, Issue 1, 2014, Pages

  McNaughton, Rhian ^a,b   Huet, Gwenaël ^a   Shakir, Saad ^a,b  

^a DRUG SAFETY RESEARCH UNIT   (United Kingdom)

^b UNIVERSITY OF PORTSMOUTH   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACEPROMAZINE; ACEPROMETAZINE; BENFLUOREX; BUFEXAMAC; BUFLOMEDIL; CARISOPRODOL; CLOBUTINOL; CLORAZEPATE; DEXTROPROPOXYPHENE; LUMIRACOXIB; MELAGATRAN; NEFAZODONE; ORCIPRENALINE; RIMONABANT; ROFECOXIB; ROSIGLITAZONE; SIBUTRAMINE; SITAXSENTAN; THIORIDAZINE; VALDECOXIB; VERALIPRIDE; XIMELAGATRAN;

ADVERSE DRUG REACTION; ARTICLE; CARDIOVASCULAR DISEASE; CASE CONTROL STUDY; COHORT ANALYSIS; CONTROLLED STUDY; CUMULATIVE ADVERSE EFFECT; DECISION MAKING; DRUG FATALITY; DRUG MARKETING; DRUG MISUSE; DRUG OVERDOSE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG WITHDRAWAL; EUROPEAN UNION; HEART DISEASE; HUMAN; ICELAND; INTOXICATION; LIECHTENSTEIN; LIVER TOXICITY; MENTAL DISEASE; META ANALYSIS (TOPIC); NEUROLOGIC DISEASE; NORWAY; PSYCHOMOTOR DISORDER; PULMONARY HYPERTENSION; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; SKIN ALLERGY; SKIN DISEASE; THROMBOSIS; VALVULAR HEART DISEASE; DRUG RECALL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EUROPE; INFORMATION PROCESSING; POSTMARKETING SURVEILLANCE; PROCEDURES; STATISTICS AND NUMERICAL DATA; TRENDS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DATA COLLECTION; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EUROPE; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; SAFETY-BASED DRUG WITHDRAWALS;

EID: 84892860718     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2013-004221     Document Type: Article

References (12)

1. European Medicines Agency (EMA) online. 2013. http://www ema europa eu (accessed 28 Mar 2013).
2. European Medicines Agency (EMA). Guideline on good pharmacovigilance practices (GVP) Module V-Risk management systems. 2013. http://www ema europa eu/docs/en-GB/document-library/Scientific-guideline/2012/06/WC500129134 pdf (accessed 16 May 2013).
3. Arnaiz JA, Carné X, Riba N, et al. The use of evidence in pharmacovigilance. Case reports as the reference source for drug withdrawals. Eur J Clin Pharmacol 2001;57:89-91. (Pubitemid 32391420)
4. Clarke A, Deeks JJ, Shakir SA. An assessment of the publicly disseminated evidence of safety used in decisions to withdraw medicinal products from the UK and US markets. Drug Saf 2006;29:175-81. (Pubitemid 43213891)
5. Olivier P, Montastruc JL. The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France. Pharmacoepidemiol Drug Saf 2006;15:808-12. (Pubitemid 44767097)
6. Paludetto MN, Olivier-Abbal P, Montastruc JL. Is spontaneous reporting always the most important information supporting drug withdrawals for pharmacovigilance reasons in France? Pharmacoepidemiol Drug Saf 2012;21:1289-94.
7. Agnelli G, Eriksson BI, Cohen AT, et al.; EXTEND Study Group. Safety assessment of new antithrombotic agents: lessons from the EXTEND study on ximelagatran. Thromb Res 2009;123:488-97.
8. European Medicines Agency (EMA). Press Release: Astra Zeneca Withdraws its Application for Ximelagatran 36-mg film-coated tablets. 2013. http://www ema europa eu/docs/en-GB/document-library/Press-release/2010/02/WC500074073 pdf (accessed 15 Mar 2013).
9. Carne X, Arnaiz JA. Methodological and political issues in clinical pharmacology research by the year 2000. Eur J Clin Pharmacol 2000;55:781-5. (Pubitemid 30201758)
10. European Medicines Agency (EMA). Assessment Report for Acomplia (Rimonabant). 2009. http://www ema europa eu/docs/en-GB/document-library/EPAR- Assessment-Report-Variation/human/000666/WC500021280 pdf (accessed 28 Mar 2013).
11. European Medicines Agency (EMA). Press release: Thelin (sitaxentan) to be withdrawn due to cases of unpredictable serious liver injury. 2010. http://www ema europa eu/ema/index jsp?curl=/pages/news-and-events/news/2010/12/news- detail-001161 jsp&murl=menus/news-and-events/news-and-events jsp&mid=WC0b01ac058004d5c1 (accessed 28 Mar 2013).
12. European Medicines Agency (EMA). Questions and answers on the review of systemic medicines containing nimesulide. 2012. http://www ema europa eu/docs/en-GB/document-library/Referrals-document/Nimesulide-31/WC500107957 pdf (accessed 28 Mar 2013).