Background: There have been no studies of the patterns of post-marketing withdrawals of medicinal products to\nwhich adverse reactions have been attributed. We identified medicinal products that were withdrawn because of\nadverse drug reactions, examined the evidence to support such withdrawals, and explored the pattern of\nwithdrawals across countries.\nMethods: We searched PubMed, Google Scholar, the WHOââ?¬â?¢s database of drugs, the websites of drug regulatory\nauthorities, and textbooks. We included medicinal products withdrawn between 1950 and 2014 and assessed the\nlevels of evidence used in making withdrawal decisions using the criteria of the Oxford Centre for Evidence Based\nMedicine.\nResults: We identified 462 medicinal products that were withdrawn from the market between 1953 and 2013, the\nmost common reason being hepatotoxicity. The supporting evidence in 72 % of cases consisted of anecdotal\nreports. Only 43 (9.34 %) drugs were withdrawn worldwide and 179 (39 %) were withdrawn in one country only.\nWithdrawal was significantly less likely in Africa than in other continents (Europe, the Americas, Asia, and Australasia\nand Oceania). The median interval between the first reported adverse reaction and the year of first withdrawal was\n6 years (IQR, 1ââ?¬â??15) and the interval did not consistently shorten over time.\nConclusion: There are discrepancies in the patterns of withdrawal of medicinal products from the market when\nadverse reactions are suspected, and withdrawals are inconsistent across countries. Greater co-ordination among\ndrug regulatory authorities and increased transparency in reporting suspected adverse drug reactions would help\nimprove current decision-making processes.
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