Nomifensine was introduced by Hoechst AG into clinical practice in West Germany in 1976 and into the United Kingdom the following year.
Nomifensine and
Haemolytic Anaemia
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should be withdrawn from use.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).
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