“No significant increase in the rate of reactions to MB FFP compared to standard FFP”
Macopharma would like to share with you information on a position statement regarding Methylene Blue-Treated Plasma edited by the “Joint UKBTS / HPA Professional Advisory Committee* / Serious Hazards of Transfusion (SHOT)” in November 2012.
In 2002, a decision was made in the UK to provide pathogen reduced FFP for neonates and young children born after 1 January 1996 for the following reasons:
– long life expectancy after transfusion
– not exposed to vCJD agent through food stuffs (relevant if non-UK source)
Since then, Methylene Blue treated plasma has shown both a good (acceptable, valuable, comforting) performance and a good safety profile.
As a result of the French decision to withdraw MB FFP, UKBTS/HPA/SHOT have undertaken a detailed analysis of the data from the UK national haemovigilance scheme, Serious Hazards of Transfusion (SHOT) in order to see if they can detect evidence of similar concern from the current UK data. They have also reviewed the available data from France to understand the basis of their decision.
The main and remarkable conclusion of this analysis is the following:
- “The analysis of UK reactions to MB-FFP from SHOT data shows no significant increase in overall reactions or severe allergic reactions when compared to standard FFP
- Other EU countries with experience of using MB-FFP have not published concerns of increased allergic reactions to MB-FFP.
- The UK haemovigilance data have not demonstrated a statistically significant increase in the rate of reactions to MB FFP compared to standard FFP.”
The detailed statement is available on this link
This statement strengthens once again Macopharma’s firm conviction that the decision of the French authorities is unfounded.*Joint United Kingdom Blood Transfusion Services and Health Protection Agency Professional Advisory Committee