US FDA staff: More allergic reactions from Bayer drug

A higher rate of allergic reactions and deaths were reported with Bayer AG’s heart-surgery drug Trasylol in 2005, U.S. Food and Drug Administration staff reviewers said in a report released on Wednesday.

The FDA staff said they had “special concerns” about the 10 fatal allergic reactions reported in 2005 and would ask an advisory panel that meets Thursday to provide its perspective and suggestions for ways to lower the risk.

The panel of outside advisers also will be asked about studies that showed Trasylol raised risks of heart attacks, stroke and kidney problems in patients undergoing heart bypass surgery, the staff summary said.

In February, the FDA urged doctors to limit Trasylol use while the agency reviewed the research.

The agency staff said they would seek input on “potential product label alterations, or other options to address safety and/or efficacy concerns” about Trasylol, which is given by injection to prevent blood loss during cardiac bypass surgery.

Bayer, in a separate statement, said Trasylol was an important tool for reducing the need for blood transfusions and that clinical trials and 10 years of post-approval use “supports a favorable benefit-risk profile.”

Both the FDA staff and Bayer statements were posted on the agency Web site at http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4234B-index.htm .