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Figure 12.2. Incidences of reports of haemolytic anaemia, hepatic events and fever associated with nomifensine submitted to the UK manufacturer 1977-1986.

Figure 12.1. Market data for nomifensine in the United Kingdom. DDD = defined daily dose of 100 mg of nomifensine. (a) Source: UK manufacturer; (b) Source: CSM.

Figure 12.2. Incidences of reports of haemolytic anaemia, hepatic events and fever associated with nomifensine submitted to the UK manufacturer 1977-1986.

and the percentage UK market share achieved by nomifensine is shown; the total represents all antidepressant prescribing including generic compounds.

Figure 12.2 shows the incidence of reports of haemolytic anaemia, hepatic events and fever over time.

Nomifensine was first marketed as a 25 mg capsule formulation on 10 October 1977, whilst the 50 mg capsule was made available on 1 January 1979. Between 1978 and 1979 four reports of acute or chronic haemolytic anaemia occurring during treatment with nomifensine were received by the manufacturer (Table 12.1). The patients were females with an age range of 25-64 years. Three of them were taking 150 mg nomifensine daily. Each had a different history of exposure and onset of haemolytic anaemia.

The type of haemolytic anaemia was characterised as chronic or acute, depending on the pattern of symptoms, their severity and the presence or absence of intravascular haemolysis. The symptoms of chronic-onset haemolytic anaemia included lethargy, fatigue and breathlessness, whilst the acute presentation of the condition involved backache, loin pain, jaundice and haematuria and, in certain cases, fever, renal failure and cardiorespiratory collapse. The Coombs' (anti-globulin) test was positive in all four cases. All of the patients had received concomitant medication, although it was considered to be non-contributory. When nomifensine

Table 12.1.

First reports of haemolytic anaemia

received by the UK manufacturer 1978-

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