Generic Name: rosiglitazone

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A thiazolidinedione - treats Diabetes Mellitus Type II

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rosiglitazone

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What is the most important information I should know about rosiglitazone?

Do not use rosiglitazone if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before taking rosiglitazone, tell your doctor if you have congestive heart failure or heart disease, a history of heart attack or stroke, liver disease, or eye problems caused by diabetes.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them, including hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma (severe hypoglycemia can be fatal). Always keep a source of sugar available in case you have symptoms of low blood sugar. Some women using rosiglitazone have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control. Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking rosiglitazone. Talk with your doctor if you are concerned about this possibility.

What is rosiglitazone?

Rosiglitazone is an oral diabetes medicine that help control blood sugar levels.

Rosiglitazone is for people with type 2 (non-insulin-dependent) diabetes. Rosiglitazone is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes.

Rosiglitazone may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking rosiglitazone?

Do not use rosiglitazone if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before taking this medication, tell your doctor if you have:

congestive heart failure or heart disease;
a history of heart attack or stroke;
liver disease; or
eye problems caused by diabetes.

If you have any of these conditions, you may not be able to use rosiglitazone, or you may need a dosage adjustment or special tests during treatment.

Some women using rosiglitazone have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control. Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking rosiglitazone. Talk with your doctor if you are concerned about this possibility. FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether rosiglitazone passes into breast milk or if it could harm a nursing baby. Do not take rosiglitazone without first talking to your doctor if you are breast-feeding a baby.

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FDA Alerts

Special Alerts:

[Posted 11/14/2007] FDA informed healthcare professionals of new information added to the existing boxed warning in rosiglitazone's (Avandia's) prescribing information about potential increased risk for heart attacks. The new information refers to a meta-analysis of 42 clinical studies, most of which compared rosiglitazone to placebo, that showed rosiglitazone to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. At this time, FDA has concluded that there isn't enough evidence to indicate that the risks of heart attacks or death are different between rosiglitazone and some other oral type 2 diabetes treatments. People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk to their healthcare professional about the revised warning as they evaluate treatment options. Healthcare professionals are advised to closely monitor patients who take rosiglitazone for cardiovascular risks. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avandia2 and http://www.fda.gov/bbs/topics/NEWS/2007/NEW01743.html.

[Posted 08/14/2007] After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. These drugs are used in conjunction with diet and exercise to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. Manufacturers of certain drugs have agreed to the upgraded warning.

The strengthened warning advises healthcare professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their healthcare providers to discuss alternative treatments. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#rosi_pio, http://www.fda.gov/bbs/topics/NEWS/2007/NEW01683.html, http://www.fda.gov/cder/drug/InfoSheets/HCP/rosiglitazone200707HCP.htm and http://www.fda.gov/cder/drug/InfoSheets/HCP/pioglitazoneHCP.htm.

[Posted 05/21/2007] FDA informed healthcare professionals of a potential safety issue related to rosiglitazone (Avandia). An on-going analysis of safety data for the treatment of type 2 diabetes mellitus using rosiglitazone showed differing rates of ischemic cardiovascular events including heart attack or heart-related adverse events, some fatal, relative to other drugs used to treat diabetes mellitus. The clinical studies reviewed to date vary with respect to their populations, treatment regimens, and length of follow-up. Based on these data, the risk of ischemic cardiovascular events due to rosiglitazone remain unclear. Prescribers should continue to carefully make individualized treatment decisions for patients with diabetes mellitus. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avandia, http://www.fda.gov/cder/drug/InfoSheets/HCP/rosiglitazoneHCP.pdf, http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html and http://www.fda.gov/cder/foi/label/2007/021071s023lbl.pdf.

[Posted 02/20/2007] Glaxo SmithKline (GSK) notified healthcare professionals of the results of a randomized, double-blind parallel group study [ADOPT] of 4,360 patients with recently diagnosed type 2 diabetes mellitus followed for 4-6 years to compare glycemic control with rosiglitazone relative to metformin and glyburide monotherapies. Significantly more female patients who received rosiglitazone experienced fractures of the upper arm, hand, or foot, than did female patients who received either metformin or glyburide. At GSK’s request, an independent safety committee reviewed an interim analysis of fractures in another large; ongoing; controlled clinical trial and preliminary analysis was reported as being consistent with the observations from ADOPT. Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with rosiglitazone. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#rosiglitazone and http://www.fda.gov/medwatch/safety/2007/Avandia_GSK_Ltr.pdf.

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