MB-treated Plasma is declared as a safe product on the basis of individual link per product to Adverse Events in patients in FRANCE.
A recent French investigation which concerns the four treated-plasma types (Quarantine, Solvent/ Detergent, Methylene Blue, and Intercept plasma) that were delivered by the Auvergne-Loire Blood Centre between 2000 and 2011, has been published in January 2013*.
This ten-year survey in France is a retrospective study based on national Adverse Events (AE) reporting data base.
The main conclusions of this study are the following:
- “All types of FFP (Fresh Frozen Plasma) were associated with extremely very low occurrences of AEs.”
- “The main strength of this study is to bring evidence that FFP is safe in general (AEs linked to FFP transfusion are infrequent, especially the severe ones; most reported were either unlikely or minor)”
- “This survey further shows that PI for plasma (SD, BM, AI) bring some reduction in AE compared to Q plasma”
- “This study indeed confirms that all four types of FFP including MB that delivery has been stopped on the claim of allergies in patients are safe on the basis of individual link per product to AEs in patients. “
There is no discrimination into the different AEs, especially the allergy cases are not separately analysed.
This French analysis strengthens once again Macopharma’s firm conviction that the decision of the French authorities is unfounded.
*A regional haemovigilance retrospective study of four types of therapeutic plasma in a ten-year survey period in France, V. Bost, H. Odent-Malaure, P. Chavarin, H. Benamara, P. Fabrigli & O. Garraud; Vox Sanguinis 2013