Avandia's Black Box Warning

A black box warning is the strongest safety warning issued by the U.S. Food and Drug Administration. Named for their black borders, the warnings are supposed to call attention to life-threatening or very serious potential side effects of a drug.

They are the most serious action the FDA can take without recalling a drug or subjecting it to strict regulations. It was this type of warning that the FDA issued for Type II diabetes drug Avandia, after a study was published showing that Avandia raises its users’ risk of heart attacks by 43 percent and their risk of death from heart problems by 64 percent.

The black box warning on Avandia’s label was issued in May 2007 and revised twice in the following six months. The original warning said Avandia may raise the risk of congestive heart failure; its August revision added a warning that Avandia may worsen heart failure; and the November revision finally included a warning that Avandia may raise patients’ risk of heart attacks. These revisions have done nothing to silence critics who point out that the warning is written in “medicalese” that not all patients can understand; for example, the label refers to heart attacks as myocardial infarctions. And of course, many others wonder why the FDA has not chosen to take Avandia off the market altogether, or taken stronger steps to restrict its use.

That question is particularly troubling because emerging evidence shows that the FDA knew about Avandia’s cardiac risks before the May 2007 study came out. The agency’s own public statements acknowledged that it had “recently” received evidence showing the same safety problems that the New England Journal of Medicine Report uncovered. In Congressional hearings shortly after, it was revealed that some FDA regulators had called for a black box warning months before the study; one expert had sent a letter with concerns as early as 2000. The same hearings revealed that agency officials estimated that Avandia may have caused 60,000 to 100,000 avoidable heart attacks between 1999 and 2006.

Furthermore, regulators elsewhere in the world have reacted more strongly to the news that Avandia causes life-threatening cardiac events. Health Canada has banned the drug’s use with multi-drug cocktails or insulin, and restricted it to last-resort use for diabetics for whom other drugs have failed. European Union regulators never approved Avandia for heart patients in the first place, and strengthened Avandia’s warning labels there in October 2007. Despite all of this, the FDA refuses to take Avandia off the market, saying it needs more conclusive evidence that the medication causes heart problems. In July 2007, two months after the New England Journal of Medicine report, only one out of 23 FDA panelists voted for an Avandia recall.

In the wake of these concerns, Congressional regulators have started asking why the FDA didn’t take action sooner, or take more drastic action to protect the public from this potentially dangerous drug. The House Committee on Government Oversight and Reform has held hearings investigating why the FDA has not conducted its own post-market study. These hearings spawned another Congressional investigation when they revealed intimidation tactics by Avandia’s manufacturer, GlaxoSmithKline. Dr. John Buse, a diabetes expert, testified that he spoke out on Avandia’s potential to increase its users’ risk of heart problems in 1999, only to be threatened with a lawsuit by the manufacturer over potential financial losses to the company. This surprising news spurred another Congressional investigation, by the Senate Finance Committee, which found that GlaxoSmithKline harassed and intimidated the doctor. The investigation also found that the manufacturer, like other drug companies, maintained an overly cozy relationship with the FDA that allowed it to stifle concerns Avandia’s relationship to heart problems -- until the independent study was published.

Between the time of Avandia’s FDA approval in 1999 and the first black box warnings, GlaxoSmithKline said, doctors wrote 80,000 new prescriptions for the drug each week. Its U.S. sales alone once topped $2.2 billion a year. Since the black box warnings began, new prescriptions for the drug have fallen by as much as 60 percent, and the company’s stock has suffered. This is exactly what GlaxoSmithKline sought to avoid when it ignored important information about Avandia’s safety. The eight-year delay between FDA approval and the revelations about Avandia means that millions of diabetics have been exposed to serious health risks; thousands may have died or suffered serious heart problems while GlaxoSmithKline stock stayed high.

If you suspect Avandia use may have led to a heart attack, heart failure, primary pulmonary hypertension or the death of someone you care about, you deserve answers. Call Anapol Schwartz today to discuss a possible Avandia lawsuit.

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AVANDIA INFORMATION
Dates you took Avandia	January February March April May June July August September October November December 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 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 1901 To January February March April May June July August September October November December 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 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 1901
Side Effects from Avandia:	Heart Attack Congestive Heart Failure Macular Edema Stroke Liver Complications PPH / Valve problems Other
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