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Trasylol to Undergo another FDA Safety Review After Canada Halts Clinical Trial

Oct 29, 2007 | Parker Waichman Alonso LLP

Trasylol will be the subject of yet another Food & Drug Administration (FDA) safety review, after a clinical trial involving the drug was halted because of indications that Trasylol increased patients’ risk of dying.  Just last month, an FDA advisory panel had recommended that the clotting drug be allowed to remain on the market, despite the fact that it was linked to serious side effects like kidney failure.

Trasylol, known generically as aprotinin, is marketed by Bayer AG.  Trasylol was approved in 1993 and is used during heart bypass surgeries to prevent bleeding.  Last year, a study published in the Journal of the American Medical Association found that Trasylol increased the risk of death by about 50 percent for some patients.  A second 2006 Trasylol study, known as the I3 drug report, suggested that Trasylol increased the risk of a patient dying by 54 percent.  That study, which analyzed a database of hospital patients treated with the drug, suggested that Trasylol could also increase the likelihood of serious kidney damage, congestive heart failure and strokes.
 
Last December, the FDA updated the Trasylol label to include a black box warning – the agency’s strictest safety notice – stating that the drug placed patients at a high risk of kidney failure.  The black box warning also cautioned that the use of Trasylol should be reserved only for patients who were at risk for significant blood loss during bypass surgeries.  In September, an FDA advisory panel agreed with the assessment that Trasylol had a high risk of causing serious side-effects, and it recommended that Trasylol undergo further clinical testing.   But the FDA panel also voted that Trasylol should stay on the market.

The latest Trasylol troubles began last week, after it was learned that Canadian regulatory authorities had halted a clinical trial that was comparing the effectiveness of Trasylol with other similar drugs.   The Canadian Data Safety Monitoring Board had stopped the Trasylol trial after a data analysis indicated that 30-day mortality risk in the study’s Trasylol patients was nearing “statistical significance”.  While the patients in this Trasylol clinical trial did experience less serious bleeding, there were more deaths due to hemorrhage in the Trasylol group.

Last week, the FDA issued new guidance on Trasylol based on the Canadian findings.   In issuing this latest warning, the FDA said that that doctors who are considering using Trasylol should be aware of the risks and benefits of the drug, as well as the accumulating data suggesting Trasylol increases the risk of death compared to other antifibrinolytic medications.

The FDA also announced that it would be conducting another review of Trasylol’s safety in light of the Canadian clinical trial.  Depending on its findings, the FDA could decide to once again modify Trasylol’s label, or it could take other regulatory action to restrict its use.