Nomifensine and Haemolytic Anaemia

Nomifensine and Haemolytic Anaemia

INTRODUCTION

Nomifensine was introduced by Hoechst AG into clinical practice in West Germany in 1976 and into the United Kingdom the following year. It was thought to have the advantages over older tricyclic antide-pressants of causing less sedative, anti-cholinergic, cardiac and epileptogenic effects. The drug was with-drawn almost a decade later in January 1986 because of the occurrence during treatment of acute immune haemolytic anaemia associated with serious clinical sequelae. In the United Kingdom, these included three fatalities, occurring in 1985.

This chapter discusses the response of the company to a drug alert in the post-marketing phase. With the benefit of hindsight several years later, this might seem a relatively straightforward task; it was a clear-cut case of increased recognition of a poten-tially life-threatening type B adverse reaction, acute immune haemolytic anaemia. Although reported in small numbers, the unpredictability and speed of onset of the reaction precluded advice to doctors on early diagnosis and treatment. It was this, as much as the distressing condition and the consequences of medi-cal and surgical intervention (including exploratory laparotomies), that prompted the manufacturer to withdraw the product in the interests of patient safety.

Until the company made its announcement on 22 January 1986 in full consultation with the regulatory authorities, there had been no suggestion in the medi-cal literature, the general or medical press or any other media that the drug should be withdrawn from use. Whilst the product withdrawal was co-ordinated worldwide, this account of the events leading up to the withdrawal relates only to the situation in the United Kingdom (Stonier, 1992).

Over the years since the withdrawal, those with legal, political and consumer interests were able to come to their own conclusions about the product and the activities of prescribers, regulators and the manu-facturer, which turned nomifensine into something of an international ‘affair’ (Schönhöfer, 1991).