September 20, 2006
FDA staff: More deaths with Bayer heart drug Trasylol
By Lisa Richwine
WASHINGTON - A higher number 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. Four fatal allergic reactions had been reported in 2004.
The panel of outside experts 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 drug's generic name is aprotinin.
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.
The FDA usually follows recommendations from its advisory panels.
German company Bayer said that Trasylol is 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."
The company has started talks with the FDA about possible changes to Trasylol's label instructions and has recommended development of a blood test to tell when a patient is at risk for an allergic reaction, Bayer spokeswoman Staci Gouveia said.
Now, doctors are advised to give a small test dose first. FDA staff said they were concerned about "the utility of the 'test' Trasylol dose procedure in light of the apparent failure to predict fatal hypersensitivity reactions."
The test dose itself reportedly resulted in 19 deaths among 51 fatalities linked to allergic reactions, the staff summary said.
Trasylol sales were 75 million euros ($95 million) for the first half of 2006. In December 2005, Bayer predicted the drug's annual sales could reach more than 500 million euros ($635 million).
Summaries by the FDA staff and were posted on the agency Web site at http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4234B-index .htm.
Shares of Bayer fell about 0.6 percent in German trading. In New York Stock Exchange trading, Bayer shares were down 0.3 percent at mid-day.
(Additional reporting by Sitaraman Shankar in Frankfurt)