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Precautions and Warnings With Rosiglitazone

Some Rosiglitazone Warnings and Precautions:

Patients taking this drug should be aware of the following precautions and warnings:

 

  • Some studies have suggested that rosiglitazone may increase the risk of heart attacks. However, other studies have not shown an increased risk. At this time, there is not enough evidence to know for sure if rosiglitazone actually increases the risk of heart attacks.

  

  • Rosiglitazone can cause fluid retention (gaining water weight, known medically as edema). For most people, this is not dangerous. However, fluid retention can be serious in people with congestive heart failure (CHF). It is possible for fluid retention to lead to heart failure, even in people who have no history of heart failure or any other heart disease. There may be an increased risk of edema or heart failure for people taking both rosiglitazone and insulin.
If you notice any of the following symptoms, contact your healthcare provider: unexplained weight gain (three to five pounds in a week); swelling of the ankles, feet, or legs; cough; and shortness of breath (see Symptoms of Congestive Heart Failure for more signs and symptoms).
  • In studies, combining insulin with rosiglitazone appeared to increase the risk of problems such as congestive heart failure and heart attacks. In general, it is not recommended to combine rosiglitazone with any type of insulin.

 

  • Rosiglitazone cannot be used to treat type 1 diabetes or diabetic ketoacidosis (a life-threatening condition that may occur with uncontrolled diabetes). These conditions need to be treated with insulin (see Avandia and Type 1 Diabetes).
     
  • Taking rosiglitazone with other medications for diabetes can increase your risk of low blood sugar (hypoglycemia) (see Avandia and Blood Sugar).

 

  • Rosiglitazone may increase the risk of fractures (broken bones) in women. These fractures are typically different than those seen in postmenopausal women with osteoporosis. In a recent study, women taking rosiglitazone were more likely to have broken bones -- especially in the upper arm, hand, or foot. Other studies suggest that men taking rosiglitazone may also be at a higher risk for fractures. 

 

  • There have been reports of rosiglitazone causing macular edema (a condition of the eye). Tell your healthcare provider if you have any vision changes.
     
  • Rosiglitazone can cause weight gain. During clinical studies, people taking rosiglitazone gained about 2 to 12 pounds on average (see Avandia and Weight Gain). Talk to your healthcare provider about rapid weight gain, as this may be a sign of fluid retention.
     
  • If you are a pre-menopausal woman who has infertility problems (due to lack of ovulation), rosiglitazone may increase your chance of ovulation (and pregnancy). Talk to your healthcare provider about birth control options if you would like to avoid pregnancy while taking rosiglitazone.
     
  • Rosiglitazone may cause increased liver enzymes. Very rarely, this can lead to liver damage. It is recommended that liver enzymes be checked in all people before starting rosiglitazone and should be checked again periodically. Liver enzymes are checked using a blood test. Rosiglitazone should not be started in people with high liver enzymes. Rosiglitazone should be stopped if liver enzymes increase and continue to stay high, as this may be a sign of liver damage.
     
  • Rosiglitazone can interact with certain medications (see Drug Interactions With Rosiglitazone).
 
  • Rosiglitazone is a considered a pregnancy Category C medication. This means that rosiglitazone may not be safe to use during pregnancy. Talk to your healthcare provider about the risks and benefits of using rosiglitazone during pregnancy (see Avandia and Pregnancy Risk for more information).
     
  • It is not known if rosiglitazone passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, be sure to talk with your healthcare provider about this.
     
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