Chamber and committees

Question reference: S2W-01553

Asked by: Brian Adam, MSP for Aberdeen North, Scottish National Party
Date lodged: 16 July 2003
Current status: Answered by Tom McCabe on 13 August 2003

Question

To ask the Scottish Executive how many adverse reactions in the use of factor (a) VIII and (b) IX in the treatment of haemophilia have been reported in each of the last 10 years.

Answer

The Medicines and Healthcare products Regulatory Agency (MHRA) has reported that it has received a total of 58 adverse drug reaction (ADR) reports associated with Factor VIII and 15 ADR reports associated with Factor IX in the last 10 years. The numbers of ADR reports per year are detailed in Table 1. Table 1. Number of UK Adverse Drug Reaction (ADR) Reports¹ Associated with Factor VIII and Factor IX products in the Last 10 years (1993-2002)

Year	Factor VIII	Factor IX
1993	5	0
1994	8	3
1995	5	1
1996	10	2
1997	6	2
1998	4	1
1999	1	1
2000	6	3
2001	1	2
2002	12	0
Total:	58	15

Note:1. The number of ADR reports relates to the total number of reports associated with the active products Factor VIII and Factor IX. No distinction has been made as to whether the product originated from human blood or from recombinant DNA technology.MHRA point out that it is important to note that a report of a suspected ADR does not necessarily mean that it was caused by the medicine.

See all of Brian Adam's questions