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Bayer Suspends Trasylol Sales November 5, 2007

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FDA Gets Trasylol Off the Market

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FDA Requests Marketing Suspension of Trasylol

Contact a Trasylol Lawyer for a free legal consultation about your Trasylol Lawsuit


The FDA announced on November 5, 2007, that Bayer Pharmaceuticals Corp. will cease the marketing and sale of Trasylol. This drug, which is used to control bleeding during heart surgery, must now undergo a detailed review of test results from a Canadian study. The BART sutdy revealed an increased risk for death from use of Trasylol (generically known as aprotinin).

The FDA issued its request to Bayer in order to maximize patient safety. Given that the side effect, death, is of the most serious nature, the FDA is being very cautious based on the preliminary BART study data. While the FDA, as of November 5, 2007, has not been provided with the full study data, to expects to act aggresively with Bayer, the Ottawa Health Research Institute, and regulatory agencies to perform a detailed analysis of data.

"Our experience tells us that when a drug is pulled in the middle of a study, and the study is terminated due to the negative side effects, that the risk assocaited with the danger is usually very significant. Once the FDA and the public are provided with the study data, we will better be able to understand the risks and benefits of Trasylol," said Jim Ronca, Esquire, the attorney at Anapol Schwartz handling the Trasylol cases.

There are alternatives to the drug Trasylol, although there not many treatment options. This means that the FDA must continue to work with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.

Our Trasylol lawyers believe that once FDA sees the data from the BART study, it will determine and identify when Trasylol could still be used. That will only be in more rare cases than Trasylol is currently used. Only when the benefits of Trasylol outweigh the risks, will this drug be permitted to be used. This will require individual doctors to identify specific cases where benefit outweighs risk. The public should expect a limited use of Trasylol in the future.

These actions, by the FDA, follow notification by the Ottawa Health Institute, which stopped a study on Trasylol because the drug appeared to increase the risk for death compared to two other antifibrinolytic drugs used in the study.

Do you need a Trasylol lawyer?

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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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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