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.

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.

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. 

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".

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.

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.

Follow 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.

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.

Test your blood sugar regularly as your doctor tells you.

Rosiglitazone can cause new or worsen heart failure. 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