About Trasylol

Heart Attack Risk after Heart Surgery

Bayer Suspends Trasylol Sales November 5, 2007

Benefits of Retaining Anapol Schwartz

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FDA Gets Trasylol Off the Market

BART Study Enrollment Ceases due to problems with Trasylol Safety.

Trasylol Wrongful Death Complaint

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BART Study Suggests Problem with the Drug Trasylol

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BART Study May Get Suspended

On October 19, 2007, FDA was notified of the Data Safety Monitoring Board’s (DSMB) recommendation to stop patient enrollment in the aprotinin BART study. This early termination may signal problems with the drug. Aprtinin is marketed as Trasylol by Bayer, Inc.. Trasylol is used in blood conservation during surgery. The randomized trial in a cardiac surgery population (BART) study has preliminary findings suggesting that when compared to the antifibrinolytic drugs, epsilon-aminocaproic acid and tranexamic acid, aprotinin increases the risk of death.

The study had planned to follow 3,000 adult Canadian patients who were to have heart surgery and were at a high risk for bleeding.

The interim analyses showed that the 30-day mortality in the aprotinin group was stastically significant. The increased death rate in the aprotinin patients was observed in the study. Thus, the use of aprotinin for less serious bleeding cases could be a problem in terms of risk benefit.

Once additional data is collected, analyses will assess the findings from the BART study and determine if the drug should be pulled from the market.

The FDA anticipates re-evaluation of the overall risks and benefits of Trasylol. This re-evaluation may result in the drug being pulled from the market. An alternative would be to revise the labeling. Doctors are now on notice that the benefits of this drug may not outweigh the risks in many cases. Data is mounting against Trasylol, suggesting Trasylol administration increases the risk for death compared to other antifibrinolytic drugs.

Trasylol is used for prophylactic use to reduce perioperative blood loss in the course of coronary artery bypass graft (CABG) surgery.

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Do you have a Trasylol/Aprotinin Lawsuit? Do you need a Trasylol/aprotinin lawyer to fight for you? Do you have an unsafe aprotinin lawsuit? Isn’t it about time to consider the options?

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TRASYLOL LAWSUIT INFORMATION

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Date of surgery:	MM January February March April May June July August September October November December DD 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 YYYY 2009 2008 2007 2006 2005 2004 2003 2002 2001 2000 1999 1998 1997 1996 1995 1994 1993 1992 1991 1990 1989 1988 1987 1986 1985 1984 1983 1982 1981 1980 1979 1978 1977 1976 1975 1974 1973 1972 1971 1970 1969 1968 1967 1966 1965 1964 1963 1962 1961 1960 1959 1958 1957 1956 1955 1954 1953 1952 1951 1950 1949 1948 1947 1946 1945 1944 1943 1942 1941 1940 1939 1938 1937 1936 1935 1934 1933 1932 1931 1930 1929 1928 1927 1926 1925 1924 1923 1922 1921 1920 1919 1918 1917 1916 1915 1914 1913 1912 1911 1910 1909 1908 1907 1906 1905 1904 1903 1902
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Kidney failure Stroke Heart attack Heart failure Encephalopathy/brain disease Death
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