Vol. 568 No. 1
567 Mr. R. Bruton asked the Minister for Health and Children if he has received reports of side effects to children from a BCG batch administered towards the end of 2002 in the Dublin area; if guidelines have been issued on the appropriate treatments of the resultant skin abscesses; and if is satisfied that the public is adequately informed regarding the difficulty and protected against it. [15622/03]
The Irish Medicine Board, IMB, has advised that it is aware of this issue and has discussed it with its Advisory Committee for Human Medicines and the National Immunisation Committee. They state that this is a known complication of all BCG vaccines and the risks are clearly outlined on the licence for this product. The IMB has sent information and guidance to all doctors via its monthly index of medical specialties, MIMS, and plans to include an item on the issue in their drug safety newsletter which will be sent to all doctors in the coming weeks.
The product information for the BCG vaccine clearly outlines known side effects of BCG. A review of the last update on safety from the company, which includes worldwide data from 1996 to 2002, suggests that cases notified to the IMB appear to be similar to a cluster previously described in Sweden. Following investigation of the Swedish cases, they were thought to have been associated with inappropriate administration.
Prescribers are reminded of the importance of administering the vaccine intra-dermally in order to minimise the occurrence of severe local reactions. It is also important to note that the correct dosage should be administered.
