Avandaryl Warnings and Precautions (Cont.)

• Oral diabetes drugs, including Avandaryl, may increase the risk of death due to heart or blood vessel problems, compared to diabetes treatment with diet or insulin. This warning is based on one research study that looked at a diabetes medication similar to Avandaryl. At this time, it is unclear how important this risk may be in people taking Avandaryl.
   
• Avandaryl can cause fluid retention (gaining of 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 Avandaryl and insulin.

If you notice any of the following symptoms, contact your healthcare provider: unexplained weight gain (three to five pounds or more in a week); swelling of the ankles, feet, or legs; cough; or shortness of breath (see Symptoms of Congestive Heart Failure for more signs and symptoms).

• If you are allergic to sulfonamides ("sulfa" medications), you may also be allergic to Avandaryl. However, not everyone who has a sulfa allergy will be allergic to Avandaryl. Be sure to let your healthcare provider know if you have a sulfa allergy.
   
• Avandaryl can cause low blood sugar (hypoglycemia) in some people. This has been more common in elderly people and in people with adrenal, pituitary, liver, or kidney problems -- as well as during fasting before surgery and after prolonged exercise. Low blood sugar symptoms may include irritability, trembling, cold sweats, or blurry vision, among other things (see Avandaryl and Blood Sugar for more information).

• Avandaryl 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 Avandia^® (rosiglitazone) were more likely to have broken bones -- especially in the upper arm, hand, or foot. Since rosiglitazone is one of the components of Avandaryl, women taking this drug may be at higher risk for broken bones.

   
• Avandaryl 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.
   
• There have been reports of Avandaryl causing macular edema (a condition of the eye). Tell your healthcare provider if you have any vision changes.
   
• Avandaryl can cause weight gain. In studies, people taking Avandaryl gained about 4 to 7 pounds on average over 28 weeks (see Avandaryl 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 a lack of ovulation), Avandaryl 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 Avandaryl.
   
• Avandaryl may cause increased liver enzymes. Very rarely, this has led to liver damage. It is recommended that liver enzymes be checked prior to starting Avandaryl and they should be checked again periodically. Liver enzymes are checked using a blood test. Avandaryl should not be started in people with high liver enzymes. Avandaryl should be stopped if liver enzymes increase and continue to stay high, as this may be a sign of liver damage.
   
• Avandaryl can interact with certain medications (see Avandaryl Drug Interactions).
   
• Avandaryl is a considered pregnancy Category C medication. This means that it may not be safe to use during pregnancy. Talk to your healthcare provider about the risks and benefits of using Avandaryl during pregnancy (see Avandaryl and Pregnancy for more information).
   
• It is not known if Avandaryl passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, be sure to talk with your healthcare provider about this.
   
• Sulfonylurea medicines, such as glimepiride (one of the components of Avandaryl), have been reported to increase the sensitivity to the sun. Therefore, when going outdoors, try wearing long sleeves, pants, and a hat. Any exposed skin should be covered with sunscreen that is at least SPF 15.