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Trasylol (Aprotinin) Drug Temporarily Suspended

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As from 7th December 2007, the Drug Trasylol, used to prevent blood loss during surgery has been temporarily suspended pending the outcome of a full Europe-wide review of the balance of the risks and benefits of the drug.

The drug has been under a cloud for more than a year following suggestions that the it may increase the risk of death, serious kidney damages and stoke. In February 2006 the US Food & Drug Administration issued a public health advisory notice alerting doctors that Trasylol, also known as Aprotinin, had been linked in two scientific publications to higher risks of serious side effects including heart attack and stroke in patients who had undergone heart bypass surgery. This study involved 67,000 patients, 30,000 of whom received Trasylol and the rest other anti-fibrinolytics.

The study concluded Trasylol carried greater risks. Despite this, the drug continued to be marketed on the basis that the clinical benefit of reduced blood loss was necessary to medical management and outweighed the potential risks. Further public health advisory updates were provided in October 2006, warning clinicians to consider limiting their use of the drug.

In September 2007 Trasylol was reviewed again when the Cardiovascular and Renal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee convened to discuss safety issues associated with the drug, the outcome being that the drug Trasylol should remain on the market despite the safety concerns committee members have had with the product. The Panel members said the data suggesting mortality risks was not strong enough to warrant pulling the drug from the market.

In September 2007 the advisory panel decided that the drug should remain on the market despite its increased risks; however it urged the producers of the drug, Bayer, to conduct a clinical trial. A Canadian study called the Bart study followed. In October 2007 we were informed that this study had been suddenly stopped due to emerging serious safety concerns about the drug.

On the 5th November 2007 Trasylol was suspended from the American markets and on 7th December 2007 there was a worldwide suspension pending the outcome of a full Europe-wide review of the balance of risks and benefits. The review was expected to take at least three months. We wait to see whether or not the final analysis of the study, due to be released in March 2008 leads to the withdrawal of Trasylol from the market altogether.

has been negatively affected by this drug, our drug liability team can help. Fill in our online claims form for free advice.