Rosiglitazone

Rosiglitazone is a prescription medication used to treat symptoms of type 2 diabetes. Rosiglitazone belongs to a group of drugs called thiazolidinediones. It increases the body's response to insulin. 

This medication comes in tablet form and is taken once or twice daily, with or without food.

Common side effects include new or worse heart failure, headache, and cold-like symptoms. 

Rosiglitazone 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.

Rosiglitazone may be found in some form under the following brand names:

• Avandia

Rosiglitazone 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 rosiglitazone reported in clinical trials included cold-like symptoms and headache.

This is not a complete list of rosiglitazone 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 for prevention of heart disease or stroke

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

In 2010 the FDA severely restricted the use of rosiglitazone, due to the risk of "cardiovascular events" such as heart attacks and strokes. After thorough review and analysis of the research, the FDA announced, in 2013, that there is not an increased risk of cardiovascular events, compared to treatment with standard diabetes medications. Use of this medication is no longer restricted.

Rosiglitazone may cause serious side effects, including:

New or worse heart failure

• Rosiglitazone 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 rosiglitazone.
• If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, rosiglitazone 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

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

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.

Rosiglitazone 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 rosiglitazone.

Before receiving rosiglitazone, 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 rosiglitazone and during treatment as needed.
• had liver problems while taking Rezulin (troglitazone), another medicine for diabetes.

Tell your doctor if you 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. Rosiglitazone should not be used during pregnancy. It is not known if rosiglitazone 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, rosiglitazone may increase your chances of becoming pregnant. Talk to your doctor about birth control choices while taking rosiglitazone. Tell your doctor right away if you become pregnant while taking rosiglitazone.

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

• Rosiglitazone 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 rosiglitazone, 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 rosiglitazone and during treatment as needed. Your doctor should also do regular blood sugar tests (for example, “A1C”) to monitor your response to rosiglitazone.

Take rosiglitazone 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 rosiglitazone is 8 mg.

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

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

WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL INFARCTION

• Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients. After initiation of rosiglitazone, 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 rosiglitazone must be considered.
• Rosiglitazone is not recommended in patients with symptomatic heart failure. Initiation of rosiglitazone 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 rosiglitazone to placebo, showed rosiglitazone to be associated with a statistically significant increased risk of myocardial infarction. Three other trials (mean duration 46 months; 14,067 total patients), comparing rosiglitazone 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 rosiglitazone 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.