Avandia: Background and Side Effects

Avandia is prescribed to Type II (adult-onset) diabetics who have trouble controlling their blood sugar through diet and exercise alone. Because it can lower blood sugar in many people without a need for injected insulin, or along with insulin and other medications, Avandia was originally heralded as a breakthrough in treatment for the 20 million Type II diabetics in the United States. At the peak of Avandia’s popularity, about 1 million Americans used the drug, which generated U.S. sales of $2.2 billion in 2006 alone. Unfortunately, patients have since learned that Avandia is associated with an increased risk of heart attacks and other serious cardiovascular problems. As a result, many patients are now moving away from Avandia. More and more families that have lost a loved one or experienced severe heart problems because of Avandia are now considering filing Avandia lawsuits.

In May of 2007, the New England Journal of Medicine published a study indicating that Avandia raises patients’ risk of heart attacks (myocardial infarction) by 43 percent. The study also found that diabetics’ risk of death from heart disease or congestive heart failure was raised by 64 percent when they took Avandia. Because two of three diabetics already die of cardiovascular problems, this discovery meant thousands or even millions of patients were at an increased risk of death or disability. After the study came out, evidence emerged showing that GlaxoSmithKline may have known about this risk as early as 1999, but did not disclose it to the FDA until early 2007, and even threatened to sue a diabetes expert who tried to warn the public about Avandia’s serious safety problems.

In response, the U.S. Food and Drug Administration ordered manufacturer GlaxoSmithKline to add a “black box” warning about potential heart problems to the drug’s label -- the most serious warning available. The warnings on this label have been strengthened twice since that order, most recently in mid-November of 2007, to add specific information amid increasing concerns about Avandia’s effect on patients’ hearts.

Cardiac Side Effects
In response to these safety concerns, the FDA has changed its patient information about Avandia’s side effects. In addition to requiring the black box warning, the agency strongly suggests that doctors rule out using Avandia in patients with heart failure or a history of heart attacks (myocardial infarction). Avandia is also no longer recommended for use in patients who are already taking nitrates or insulin. And the FDA warned doctors and patients taking Avandia to watch for symptoms of heart failure or heart disease, including:

• Retaining fluid and swelling (edema), especially in the lower body
• Rapid unexplained weight gain
• Shortness of breath (dyspnea)
• Trouble breathing while lying down
• Unexplained fatigue
• Heart palpitations
• Chest pain (angina)

Liver Failure
Even before the risk of heart attacks was well known, doctors knew Avandia carried another very serious side effect: A risk of liver toxicity, which can lead to death or the need for a liver transplant. Because the medication is in a class of drugs known to cause liver failure, doctors must do regular liver function tests with Avandia patients. Patients with a known liver disease or symptoms of liver failure were advised to consider other medications. Patients taking Avandia and their doctors are warned to watch for symptoms of liver disease, which include:

• Nausea
• Vomiting
• Stomach pain
• Unexplained fatigue
• Loss of appetite
• Dark urine
• Yellowing of the skin and eyes (jaundice)

Other Serious Side Effects
Avandia has still other side effects, some of which are also quite serious. They include:

• Very low blood sugar (hypoglycemia)
• In women, an increased risk of broken bones
• Anemia (low red blood cell count), which can lead to fatigue
• Cold symptoms
• Sinus inflammation
• Back pain
• Headache
• In premenopausal women who had stopped menstruating, an increased risk of pregnancy

Do you think Avandia may have caused heart attacks, heart disease or death for someone you care about? Talk to us. An Avandia lawsuit may be in your future.

Please fill out the form below to see if you have an Avandia case.

* Click on the Disclaimer, below, for Terms HOW MAY WE CONTACT YOU?
First Name:
Last Name:
Address:
City:
Zipcode:
Phone #1:	() - ext.
Phone #2:	() - ext.
E-mail Address:
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
What happened? Please describe any problems or ask any questions.