§ Mr. LansleyTo ask the Secretary of State for Health (1) how many recorded incidences of pure red cell aplasia there were in England and Wales between 1999 and 2002 following treatment using erythropoietic products; [149173]
(2) if he will list the incidences of pure red cell aplasia occurring after treatment with (a) Epogen, (b) Aranesp, (c) Neorecormon and (d) Eprex since 1999; [149174]
(3) how many fatalities have been linked to the use of erythropoietic treatments for anaemia; [149175]
(4) if he will commission studies into the incidence of pure red cell aplasia after erythropoietic treatments for anaemia; and what studies he has assessed into the
Number of case reports of red cell aplasia received 1999 2000 2001 2002 2003 Epoetin alfa (Eprex) United Kingdom 4 4 9 21 6 England and Wales only 4 3 8 19 6 Epoetin beta (Neorecormon) United Kingdom 4 2 0 7 1 England and Wales only 4 1 0 7 1 The total number of suspected ADR reports received from UK sources between the start of 1999 and the end of 2003 in association with epoetin alfa was 44; the number associated with epoetin beta was 14. Both epoetin alfa and epoetin beta were implicated in 10 reports; therefore the total number of reports of red cell aplasia received in association with all epoetins was 48.
The cause of death was recorded as red cell aplasia in one case. This patient showed evidence of parvovirus B 19 infection, which is a well-established cause of red cell aplasia. Therefore, there are reasonable grounds to doubt a causal association between the epoetin administered and the red cell aplasia that occurred in this case.
Two large studies are currently under way to investigate the apparent association between epoetins and red cell aplasia, including the incidence of red cell aplasia in patients treated with epoetins.
The epoetins available in the UK were authorised on the basis of data, including clinical trial data, that have demonstrated evidence of safety and efficacy in all licensed indications. All studies were assessed for evidence of potential unwanted effects that might be attributable to treatment. The number of patients exposed to treatment prior to grant of a Marketing Authorisation would not normally be large enough to permit the detection of very rare unwanted effects, which would usually only come to light as a result of post-marketing surveillance following the exposure of much larger numbers of patients, as was the case with red cell aplasia in association with epoetins.
320Wpotentially adverse effects of erythropoietic treatments for anaemia.[149176]
§ Miss Melanie JohnsonThe Medicines and Healthcare products Regulatory Agency (MHRA) and the Committee on Safety of Medicines (CSM) receive reports of suspected adverse drug reactions (ADRs) submitted by doctors, nurses, dentists, pharmacists and coroners via the Yellow Card Scheme, and there is a legal requirement for companies to report suspected ADRs to their products.
The table shows the number of suspected ADR reports of red cell aplasia received annually by the MHRA/CSM between 1999 and 2003. These numbers do not necessarily represent all cases that may have occurred, because there is an unquantifiable degree of under-reporting associated with the Yellow Card Scheme, as with all voluntary reporting schemes. Figures are presented for epoetin alfa (Eprex), and epoetin beta (Neorecormon). The MHRA/CSM has received no ADR reports involving red cell aplasia in association with either Aranesp or Epogen during this interval. The product known as Epogen was not marketed in the United Kingdom during the interval in question.