Blood loss drug suspended over safety fears
pharmafile | November 9, 2007 | News story | Sales and Marketing |Â Â Â
A drug used to prevent excessive blood loss during surgery could be causing deaths in patients, and has been suspended from markets around the world.
Bayer has agreed to suspend Trasylol until further safety checks are made, but new clinical trial data indicates the drug could be causing kidney damage and increasing risks of heart and brain damage.
In the UK, medicines regulator the MHRA says Trasylol (aprotinin) can still be used, but only in patients where the risk of blood loss during surgery is considered to be particularly high, where there is no suitable alternative, and when the likely benefits outweigh any risks to individual patients.
Bayer and regulators were alerted to data emerging from a Canadian trial of the drug which indicated that it reduced bleeding, but also produced an increase in all-cause mortality (that almost reached conventional statistical significance for 30-day mortality) compared to patients on alternative drugs aminocaproic acid and tranexamic acid.
Bayer says it believes the drug still has a favorable risk-benefit profile when used according to labeling instructions.
The drug is estimated to make just over Euro 100 million this year, and is thus not one of the company's biggest earners, but the company is treating the data very seriously.
Bayer was forced to withdraw another of its products, cholesterol-lowering drug Lipobay in 2001 after it was linked to a number of patient deaths.






