Heart Surgery Drug Warning

The Food and Drug Administration has recently issued a warning linked to a drug used to prevent blood loss during heart bypass surgery. The FDA has started evaluating its safety in light of two studies published in January that signalled health problems associated with its use.

The drug Trasylol, formally known as aprotinin, was found to cause higher risks of side effects such as kidney problems, heart attacks and strokes. Trasylol is the only FDA-approved drug that limits the loss of blood and thus, the need for transfusions in surgeries to bypass clogged coronary arteries.

The producing company, Bayer AG, says the drug is safe and effective when used correctly during bypass graft surgery, adding that it will keep working with regulatory authorities "in all countries where Trasylol is marketed to address questions regarding product safety". The Germany-based company has already contacted officials in the United States, Canada, Australia and Europe.

The FDA have warned both patients and doctors about the use of the drug on Wednesday, advising that doctors monitor patients for toxicity, particularly to the kidneys, heart and central nervous system, after administration of the drug. Doctors are also advised to limit the use of the drug to the cases where the benefits of reducing the loss of blood outweigh the risks.

One of the studies which appeared in January, published in the New England Journal of Medicine, found that the use of Trasylol was associated with higher rates of kidney problems, heart attacks and strokes in patients who used the drug as compared to both patients who did not use any drug at all and patients who used some other medication to help prevent blood loss. The other study, published in Transfusion, indicated a higher number of patients with kidney problems among people treated with Trasylol than among people who received another treatment to prevent blood loss.

The FDA will have an advisory committee discuss the risks and benefits of the drug and decide on the measures that need to be taken.

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