Trasylol licence suspended

- Health Care Republic

12/21//2007 - The licence for Trasylol (aprotinin) has been suspended on the advice of the Commission on Human Medicines (CHM). Global marketing of the drug had already been suspended voluntarily by the marketing authorisation holders (Bayer plc and Nordic Pharma) due to safety concerns.

The CHM decision to suspend the licence was made on the basis of preliminary findings from a clinical trial (the BART study), which was stopped early after excess mortality was observed in the aprotinin arm compared with the tranexamic acid and aminocaproic acid arms (relative risk 1.5).

In addition, data from observational studies suggested an increased risk of mortality as well as an increased risk of cardiac, cerebrovascular and renal effects.

Trasylol is indicated for the reduction of blood loss and need for blood transfusion in coronary artery bypass graft surgery.

The CHM concluded that although aprotinin may be more effective than the comparator drugs at reducing bleeding, the risks outweigh the benefits.

Ennis & Ennis, P.A. is representing individuals that have been harmed as a result of Trasylol side effects. If you or a loved one have suffered as a result of Trasylol side effects such as kidney failure, heart attack, or stroke you may be entitled to compensation. For more information about a Trasylol lawsuit, a possible Trasylol recall, or for questions regarding Trasylol class action lawsuits click here for a free, confidential case evaluation.