KEY POINTS:
Medsafe has welcomed the move by German drug manufacturer Bayer AG to temporarily suspend global marketing of its anti-bleeding drug Trasylol, which has been linked to a higher risk of death, serious kidney damage and strokes.
Trasylol is used to reduce the risk of bleeding in some heart bypass surgery.
Medsafe said fewer than 50 New Zealand patients a year used the drug.
Questions have been raised over Trasylol, approved in 1993 and known under the generic name as Aprotinin, for the past year as data has associated serious risks with its use.
Bayer announced marketing of the drug would cease until the final results of a Canadian trial were received and evaluated. Medsafe said while use of Trasylol was suspended, there were other treatments available that were as effective and possibly safer.
The Canadian trial was stopped after data indicated an apparent increase in the risk of death in patients undergoing cardiothoracic surgery receiving Trasylol, compared with other anti-bleeding drugs.
Medsafe said it would wait until the complete trial data was available, to assess the risks and benefits of Trasylol before making a decision as to whether the temporary suspension on marketing could be lifted.
Medsafe issued a safety briefing about Trasylol to prescribers in October, in response to the decision to halt the trial.
In the briefing, Medsafe recommended "clinicians consider each patient on an individual basis to determine whether Aprotinin is appropriate for that patient, taking into account the accumulating data suggesting Aprotinin increases the risk for death compared to other antifibrinolytic drugs". Aprotinin has been under review by the Medicines Adverse Reactions Committee since 2006.
Since then the prescribing information for the product has been amended twice to limit the approved indications to those patients at high risk of blood loss or transfusion.
These changes were consistent with those occurring in other countries, and were implemented to help improve the benefit-risk profile of Aprotinin.
- NZPA
