Avandia Side Effects
The first indication of the risk of Avandia side effects came in 2002, when the FDA warned that GlaxoSmithKline’s diabetes drug could cause fluid retention, bad cholesterol and a rise in patients’ risk of heart failure.
Because of similarities between the drug and Rezulin—which was withdrawn in 2000 after it was linked to cases of liver failure—patients taking Avandia were also advised to have regular liver enzyme tests.
Big news published in the NEJM
More information about possible Avandia side effects was uncovered in May 2007 when a study was conducted by Dr. Steven Nissen of the Cleveland Clinic.
Published in the New England Journal of Medicine, it revealed that users were at an increased risk of heart attacks and death from heart problems. The study found a total of 158 heart attacks and 61 heart-related deaths among Avandia patients.
The study concluded that Avandia patients were 64% more likely to die of heart-related problems and 43% more likely to suffer a heart attack than patients taking another diabetes drug or a placebo.
However, because the studies they analyzed were only conducted over short periods of time, they cautioned that the risk of Avandia side effects could be even higher. Just two weeks after publication of that study in the NEJM, the FDA decided to give Avandia's label a "black-box" warning.
Barely a month later, there was more bad news for GlaxoSmithKline. The ADOPT study showed that women who take Avandia are at an elevated risk of suffering bone fractures.
Criticism of GSK
Many doctors have been critical of GSK and the agency for poorly monitoring the risk of Avandia side effects. Some have drawn comparisons between the agency’s handling of the situation and its monitoring of another drug, Vioxx, which was linked to a greater risk of heart attacks and withdrawn in 2004.
The 43% increase in the risk of heart attacks among Avandia users is similar to the heart attack danger observed with low doses of Vioxx.
Patients who take Avandia for the relief of type 2 diabetes symptoms should be alert for signs of Avandia side effects. Some have begun looking for an Avandia attorney to represent them in litigation.
