Avandia®

Avandia, in addition to diet and exercise, improves blood sugar control in adults with type 2 (non-insulin-dependent) diabetes.  Avandia can be used alone or in combination with a sulfonylurea, metformin, or insulin when diet, exercise, and one of these agents or diet, exercise, plus Avandia alone are not enough to control blood sugar.  

Who should not take Avandia?  

• Do not use Avandia for type I diabetes (juvenile diabetes) or diabetic ketoacidosis.

• If you have heart failure, fluid retention, or active liver disease your health care provider will evaluate you to decide if Avandia is right for you.  

Reports of Patients? Experiences Since Avandia Became Available:

There have been reports of inflammation of the liver (hepatitis) and elevated liver enzymes.  It has not been determined whether these events are directly related to  Avandia.  It is recommended that patients taking Avandia have their liver enzymes monitored periodically. 

General Precautions with Avandia:  

?       Avandia is in the same class of drugs as Rezulin, which has been associated with rare but serious liver injury, including liver failure leading to transplant or death.  Because Avandia?s liver safety profile is not fully determined yet, your doctor will do blood tests that evaluate your liver before starting you on Avandia.  These blood tests should be repeated every two months for the first year, then regularly after that.

?       Call your health care provider right away if you develop nausea, vomiting, stomach pain, a feeling of tiredness or having no energy, loss of appetite, dark urine, or jaundice (yellow coloring of eyes and skin).  These may be symptoms of liver problems.

?       Patients who experience an unusually rapid increase in weight or retain fluid (edema) or who develop shortness of breath or other symptoms of heart failure while on Avandia should immediately report these symptoms to their health care provider.

?       When taking Avandia with other oral diabetes medicines, there is a risk of your blood sugar becoming dangerously low.  Ask your health care provider about symptoms of low blood sugar, conditions that make low blood sugar more likely, and what to do if you get it.  Make sure to explain to family members.

?       If you are a woman who has not reached menopause but have not had menstrual periods, you may become pregnant unless you use an effective method of birth control.  Avandia, like other drugs in this class, may cause insulin resistant women to start ovulating again.

?       Women should tell their doctor if they notice any changes in their monthly menstrual  cycle.

?       During periods of stress on the body, such as fever, trauma, infection, or surgery, your medication requirements may change; contact your health care provider promptly.

Managing your diabetes should include diet control.  Caloric restriction, weight loss as needed, and exercise are essential for the proper treatment of diabetes because they help improve insulin sensitivity and the effectiveness of drug therapy.

What should I tell my doctor or health care provider?

Tell you health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.

Because certain other medication may interact with Avandia, review all medications that you are taking with your health care provider, including those that you take without a prescription.

What are some possible side effects of Avandia? (This list is not  a complete list of side effects reported with Avandia. Your health care provider can discuss with you a more complete list of side effects.)

?        cough or cold

?        headache

?        inflammation of the sinuses

?        back pain

?        swelling or fluid retention

For more detailed information about Avandia, ask your health care provider.