Avandia

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. 

Avandia is a prescription medicine used to treat type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• GlaxoSmithKline LLC

Avandia may cause serious side effects. See "Drug Precautions". Some serious side effects include:

• New or worse heart failure 
• Heart attack
• Swelling (edema) 
• Weight gain
• Liver problems. Call your doctor right away if you have unexplained symptoms such as:
  • nausea or vomiting
  • stomach pain
  • unusual or unexplained tiredness
  • loss of appetite
  • dark urine
  • yellowing of your skin or the whites of your eyes
• Macular edema (a diabetic eye disease with swelling in the back of the eye) 
• Fractures (broken bones), usually in the hand, upper arm or foot 
• Low red blood cell count (anemia)
• Low blood sugar (hypoglycemia)
• Ovulation (release of egg from an ovary in a woman) leading to pregnancy 

The most common side effects of Avandia reported in clinical trials included cold-like symptoms and headache.

This is not a complete list of Avandia side effects. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins or herbal supplements. Especially tell your doctor if you take:

• insulin
• any medicines for high blood pressure
• any medicines for high cholesterol
• any medicines for heart failure
• any medicines for prevention of heart disease or stroke

This is not a complete list of Avandia drug interactions. Ask your doctor or pharmacist for more information.

Avandia is available only through an access program. Both you and your doctor must be enrolled in the program so that you can get Avandia. To enroll, you must:

• talk to your doctor
• understand the risks and benefits of Avandia 
• agree to enroll in the program

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

Avandia may raise the risk of a heart attack. The risk of having a heart attack may be higher in people who take Avandia with insulin. Most people who take insulin should not also take Avandia.

Symptoms of a heart attack can include the following:

• chest discomfort in the center of your chest that lasts for more than a few minutes, or that goes away or comes back
• chest discomfort that feels like uncomfortable pressure, squeezing, fullness or pain
• pain or discomfort in your arms, back, neck, jaw or stomach
• shortness of breath with or without chest discomfort
• breaking out in a cold sweat
• nausea or vomiting
• feeling lightheaded

Call your doctor or go to the nearest hospital emergency room right away if you think you are having a heart attack.

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. See "Side Effects".

Follow dietary (food) recommendations made by your doctor and dietitian which should include a healthy diet. Skipping meals should be avoided as this can cause problems maintaining blood sugar control. There are no specific foods to avoid while using Avandia.

Before receiving 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 breastfeeding.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins or herbal supplements. 

Tell your doctor if you 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.

Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if Avandia passes into breast milk. You should not use Avandia while breastfeeding.

• Avandia comes as a tablet to be taken by mouth, with or without food.
• It is usually taken once or twice daily. 
• If you miss a dose of Avandia, take it as soon as you remember, unless it is time to take your next dose. Take your next dose at the usual time. Do not take double doses to make up for a missed dose.
• Test your blood sugar regularly as your doctor tells you.
• Your doctor should do blood tests to check your liver before you start Avandia and during treatment as needed. Your doctor should also do regular blood sugar tests (for example, “A1C”) to monitor your response to Avandia.

Take Avandia exactly as prescribed. Follow the directions on your prescription label carefully. Your doctor may start you on a dose of 4 mg and increase the dose if necessary.

The maximum recommended daily dose of Avandia is 8 mg.

If you take too much Avandia, call your local Poison Control Center or seek emergency medical attention right away.

• Store Avandia at room temperature. Keep Avandia in the container it comes in.
• Safely, throw away Avandia that is out of date or no longer needed.
• Keep Avandia and all medicines out of the reach of children.

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.