Understand the Risks of AVANDIA
What is the most important information I should know about AVANDIA?
AVANDIA is a prescription medicine to treat adults with type 2 diabetes. It helps to control high blood sugar. It is important that you take AVANDIA exactly how it is prescribed by your doctor to best treat your diabetes. Before starting AVANDIA, ask your doctor about what the choices are for diabetes medicines, and what the expected benefits and possible risks are for you in particular.
AVANDIA may cause serious side effects including:
- New or worse heart failure
AVANDIA can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough. If you have severe heart failure, you cannot start AVANDIA.
If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, AVANDIA may not be right for you.
Call your doctor right away if you have any of the following:- swelling or fluid retention, especially in the ankles or legs
- shortness of breath or trouble breathing, especially when you lie down
- an unusually fast increase in weight
- unusual tiredness
- Other heart problems
AVANDIA may raise the risk of heart problems related to reduced blood flow to the heart. These include possible increases in the risk of heart-related chest pain (angina) or "heart attack" (myocardial infarction). This risk seemed to be higher in people who took AVANDIA with insulin or with nitrate medicines. Most people who take insulin or nitrate medicines should not also take AVANDIA.
If you have chest pain or a feeling of chest pressure, get medical help right away, no matter what diabetes medicines you are taking.
People with diabetes have a greater risk for heart problems. It is important to work with your doctor to manage other conditions, such as high blood pressure or high cholesterol.
AVANDIA can have other serious side effects. Be sure to read the section below "What are possible side effects of AVANDIA?"
What is AVANDIA?
AVANDIA is a prescription medicine used with diet and exercise to treat adults with type 2 ("adult-onset" or "non-insulin dependent") diabetes mellitus ("high blood sugar"). AVANDIA helps to control high blood sugar. AVANDIA may be used alone or with other diabetes medicines. AVANDIA can help your body respond better to insulin made in your body. AVANDIA does not cause your body to make more insulin. For AVANDIA to work best, it is very important to exercise, lose extra weight, and follow the diet recommended by your doctor. AVANDIA has not been studied enough in children under 18 years of age to know if it is safe or effective in children. AVANDIA is not for people with type 1 diabetes mellitus or to treat a condition called diabetic ketoacidosis.
Who should not take AVANDIA?
Many people with heart failure should not start taking AVANDIA. See "What should I tell my doctor before taking AVANDIA?".
What should I tell my doctor before taking AVANDIA?
Before starting AVANDIA, ask your doctor about what the choices are for diabetes medicines, and what the expected benefits and possible risks are for you in particular.
Before taking AVANDIA, tell your doctor about all your medical conditions, including if you:
- have heart problems or heart failure.
- have type 1 (“juvenile”) diabetes or had diabetic ketoacidosis. These conditions should be treated with insulin.
- have a type of diabetic eye disease called macular edema (swelling of the back of the eye).
- have liver problems. Your doctor should do blood tests to check your liver before you start taking AVANDIA and during treatment as needed.
- had liver problems while taking REZULIN® (troglitazone), another medicine for diabetes.
- are pregnant or plan to become pregnant. AVANDIA should not be used during pregnancy. It is not known if AVANDIA can harm your unborn baby. You and your doctor should talk about the best way to control your diabetes during pregnancy. If you are a premenopausal woman (before the “change of life”) who does not have regular monthly periods, AVANDIA may increase your chances of becoming pregnant. Talk to your doctor about birth control choices while taking AVANDIA. Tell your doctor right away if you become pregnant while taking AVANDIA.
- are breast-feeding or planning to breast-feed. It is not known if AVANDIA passes into breast milk. You should not use AVANDIA while breastfeeding.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins or herbal supplements. AVANDIA and certain other medicines can affect each other and may lead to serious side effects including high or low blood sugar, or heart problems. Especially tell your doctor if you take:
- insulin.
- nitrate medicines such as nitroglycerin or isosorbide to treat a type of chest pain called angina.
- any medicines for high blood pressure, high cholesterol or heart failure, or for prevention of heart disease or stroke.
Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist before you start a new medicine. They will tell you if it is alright to take AVANDIA with other medicines.