In the wake of widespread reports of heart failures, liver damage, and other patient injuries and seemingly non-stop controversy surrounding the top-selling type-2 diabetes drug Avandia, the Food and Drug Administration now says that future diabetes drugs will face much tougher scrutiny.
Avandia, the blockbuster type 2 diabetes drug taken by an estimated six million Americans, has been linked to an increased risk of heart attack and cardiovascular death. Avandia was approved in 1999 for the treatment of type 2, or adult onset, diabetes, which affects an estimated 18 to 20 million Americans and is a leading cause of coronary heart disease, blindness, kidney failure, and limb amputation.
Diabetes occurs when the body either does not produce enough insulin or is insensitive to insulin. Avandia belongs to the family of drugs called thiazolidinediones and has been shown to increase fluid retention in the body, which is a major factor in causing congestive heart failure and other diseases.
In May 2007, the U.S. Food and Drug Administration issued a public safety alert about the risk of heart attack and cardiovascular death associated with Avandia users. The New England Journal of Medicine had published a report showing that the drug resulted in a 43% increase in the risk of heart attack and a 64% increase in the risk of death from all cardiovascular causes in patients with existing cardiovascular disease.
In that published report, researchers followed the clinical trials of more than 15,000 Avandia patients and 12,000 in a control group not taking the drug. They found 86 heart attacks in the Avandia group compared to just 72 in the control group. The report also found a higher rate of death from heart disease among Avandia patients compared to those in the control group.
In 2006, the FDA ordered an update to Avandia’s product labeling to include warnings about the risk of heart failure and the potential for an increase in heart attacks and heart-related chest pain in patients. The advisory, a so-called “Black Box” warning which is the strongest such packaging warning issued by the FDA, cautioned patients with existing congestive heart failure about the dangers of taking Avandia.
Elderly patients who took the controversial anti-diabetes drug Avandia were more likely to suffer deadly congestive heart failure than patients who took a similar drug, a new study has found.
Researchers at Harvard Medical School tracked 28,361 diabetes patients for five years. Roughly half of the patients were treated with Avandia (generic rosiglitazone) while half received a competing drug, Actos (generic pioglitazone).
Researchers found that Avandia patients were 15 percent more likely to die and 13 percent more likely to suffer congestive heart failure than patients who took Actos.
In 2007, a federal scientific advisory panel reviewed Avandia, determined the drug was safe, and recommended that it remain on the market. However, despite that vote of confidence, sales of the drug have dropped amid news of a link to heart disease.
About one million Americans still take Avandia, which helps control blood sugar by increasing the body’s sensitivity to insulin, often as part of a regimen that includes other diabetes medications.
