Introduction

This chapter has the specific objective of looking at what one national adverse drug reaction reporting scheme can provide, by way of data, regarding suspected drug toxicity affecting the haematological system in man. The reporting system chosen has been the UK "Yellow Card'' Scheme begun in 1964 by the Committee on Safety of Drugs (the forerunner of today's Committee on Safety of Medicines) under the chairmanship of Sir Derrick Dunlop. The written assurances given to prescribing doctors by Sir Derrick at the beginning of this scheme (see Mann, 1998) have been honoured over the intervening years and have allowed the accumulation of a database that can be used to explore many aspects of the clinical toxicity of drugs. These various aspects have been summarized elsewhere (Rawlins, 1986).

There are three other chapters in this volume that relate to the subject of haematological adverse drug reactions (ADRs). First, the Introduction (Mann and Andrews) provides a table listing drugs withdrawn during or since 1975 in the United Kingdom by the Marketing Authorization holder or suspended or revoked by the Licensing Author ity for safety reasons. This list of 31 drugs includes two—nomifensine (major safety concern, haemo-lytic anaemia) and remoxipride (major safety concern, aplastic anaemia)—which were withdrawn due to reports of haematological reactions. Remoxipride was an unpleasant reminder of oxyphenbutazone and phenylbutazone—also strongly associated with reports of aplastic anae-mia—which will be discussed further in this chapter.

The second chapter directly concerned with haematological ADRs is that by Stonier and Edwards (Chapter 12) on nomifensine and hae-molytic anaemia. The remarkable story of the long period that elapsed after nomifensine was marketed and before its toxic effects were recog-nized—and the way in which these effects led to the withdrawal of the drug world-wide—was first told in Peter Stonier's courageous paper of nine years ago (Stonier, 1992). The literature contains few accounts of a crucial drug disaster as experienced by a physician with keynote responsibilities within the company concerned and the relevant account is, therefore, informative.

The third chapter, which has special relevance, is that by Curel and Stather (Chapter 40). This provides a list of ''ADR headlines from 1999'' and a similar list for the year 2000. The entry for ticlopidine regarding thrombotic thrombocytopenic purpura, liver failure and agranulocytosis will be noted along with that for Rho(D) immunoglobulin regarding reports of intravascu-lar haemolysis in Rho(D)-positive patients with immune thrombocytopenic purpura. However, these useful listings show that over these two years haematological problems formed a minority of the big ADR highlights that occupied the attention of those concerned with pharmacovigi-lance.

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