Avandia is a prescription medication used along with diet and exercise to treat type 2 diabetes. Avandia belongs to a group of drugs called thiazolidinediones. It can help your body respond better to insulin.
This medication comes in tablet form and is taken 1 or 2 times a day, with or without food.
Common side effects of Avandia include new or worse heart failure, headache, and cold-like symptoms.
Because Avandia has been associated with heart attack and stroke, it is available only through an access program. Both you and your doctor must be enrolled in the program.
WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL INFARCTION
- Thiazolidinediones, including Avandia, cause or exacerbate congestive heart failure in some patients. After initiation of Avandia, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Avandia must be considered.
- Avandia is not recommended in patients with symptomatic heart failure. Initiation of Avandia in patients with established NYHA Class III or IV heart failure is contraindicated.
- A meta-analysis of 52 clinical trials (mean duration 6 months; 16,995 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with a statistically significant increased risk of myocardial infarction. Three other trials (mean duration 46 months; 14,067 total patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, showed a statistically non-significant increased risk of myocardial infarction, and a statistically non-significant decreased risk of death. There have been no clinical trials directly comparing cardiovascular risk of Avandia and Actos (pioglitazone, another thiazolidinedione ), but in a separate trial, pioglitazone (when compared to placebo) did not show an increased risk of myocardial infarction or death.
- Because of the potential increased risk of myocardial infarction, Avandia is available only through a restricted distribution program. Both prescribers and patients need to enroll in the program. To enroll, call 1-800-Avandia or visit www.Avandia.com. [1]