Important Safety Information for Avandamet® (rosiglitazone maleate/metformin HCI)
Avandamet, along with diet and exercise, helps improve blood sugar control in patients with type 2 diabetes. It is a combination of two drugs - rosiglitazone maleate and metformin HCl.
Avandamet can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart), you cannot be started on Avandamet. Avandamet is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling) even if these symptoms are not severe.
Rosiglitazone, a component of Avandamet, may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin. Taking rosiglitazone with insulin or with nitrates is not recommended.
If you have chest pain or a feeling of chest pressure, you should seek immediate medical attention, regardless of what diabetes medicines you are taking.
A small number of people who have taken metformin, one of the components of Avandamet, have developed a rare yet serious condition called lactic acidosis (a buildup of lactic acid in the blood). Lactic acidosis occurs most often in people with kidney problems and can be fatal in up to one half of the cases. You should not take Avandamet if you have kidney problems. Tests should be used to check your kidneys before and while taking Avandamet. You should not drink alcohol excessively when taking Avandamet. If you are taking medicines for heart failure, you may be at increased risk of lactic acidosis.
If you take Avandamet, tell your doctor right away if you:
- Have swollen legs or ankles, a rapid increase in weight or difficulty breathing, or unusual tiredness
- Experience changes in vision
- Become pregnant
Review your medical history and tell your doctor if you:
- Have heart failure or other heart problems
- Have liver problems or liver disease
- Are pregnant or are nursing
Women taking Avandamet should know that Avandamet may increase the risk of pregnancy
More fractures have been observed in women taking Avandamet.
For more information about Avandamet, please see Patient Information. For further information on Avandamet, please see full Prescribing Information.

