Bayer halts drug sales after study links it to risks

Pharmaceutical giant Bayer AG suspended global sales of its anti-bleeding drug Trasylol yesterday after a clinical trial led by Ottawa researchers found the drug was linked to a higher risk of death than alternative medications.

The action followed requests from the Food and Drug Administration and Health Canada that Bayer suspend sales in the United States and Canada respectively while the regulatory agencies review the preliminary findings of the BART trial.

Jirina Vlk, a spokesperson for Health Canada, said while sales are suspended Health Canada will work with Bayer to ensure the drug is available for surgeries in which the benefits of its use would exceed the risk.

Currently no alternative drugs are licensed for this use in Canada, Vlk said.

“Bayer Inc. will work with Health Canada so that the drug can be made available to certain patients in cases where the doctor believes the substantial benefit clearly outweighs the risk,” she said.

The BART trial – the acronym stands for Blood conservation using Antifibrinolytics in a Randomized Trial – was abruptly halted last month after an interim review of the safety data showed a higher rate of deaths among patients who received Trasylol than those who received the drugs it was being tested against, aminocaproic acid and tranexamic acid.

All three drugs are antifibrinolytics, drugs that stem blood loss. They are used in heart bypass surgery to reduce blood loss with the aim of trying to avoid the need for blood transfusions.

Aprotinin, Trasylol’s generic name, has been the subject of a number of studies that tested it against a placebo. In these studies, people who received the drug fared better, on average, than those who did not. But the studies were all small and didn’t have the statistical power to spot rare but serious side effects, said Dr. Michael Lincoff, director of cardiovascular clinical research at the Cleveland Clinic.

The BART trial, on the other hand, was the first to compare Trasylol to existing drugs. And it contained enough subjects to show that patients who received the drug were more likely to die in the 30 days following surgery than those who received one of the other two drugs.

The trial, led by researchers at the Ottawa Health Research Institute, was designed to randomize 2,973 heart surgery patients to receive one of the three drugs. But in a regularly scheduled safety monitoring board review, preliminary data on 2,163 patients showed a trend towards increased deaths in the Trasylol arm.

Final results will be ready in the near future, said Dr. Paul Hébert, the trial’s co-principal investigator.

Hébert, a senior scientist at the Ottawa Health Research Institute and editor-in-chief of the Canadian Medical Association Journal, said the study’s goal was to find which of three commonly used drugs best prevented massive bleeding during major cardiac surgery.

“These drugs have been in common use for 25 to 30 years now, but there have been very few studies comparing all three drugs against each other,” he told the Star’s Megan Ogilvie.

“The goal was to see what drug prevented bleeding, but instead we found a drug that increased the risk of death.”

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