Avandamet Warnings and Precautions
- Some studies have suggested that rosiglitazone (one of the components of Avandamet) may increase the risk of heart attacks and other similar problems. 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.
- Avandamet 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 Avandamet 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; 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 Avandamet with any type of insulin.
- Very rarely, metformin (one of the active ingredients of Avandamet) can cause a life-threatening condition called lactic acidosis. Your risk of lactic acidosis increases with other medical conditions, including congestive heart failure (CHF), kidney failure, and liver problems, including liver failure and cirrhosis (see Metformin and Lactic Acidosis for more information, including possible symptoms of lactic acidosis).
- Drinking alcohol can increase your risk of lactic acidosis. Drinking large amounts of alcohol on a regular basis or drinking a large amount of alcohol at once (binge drinking) should be avoided while taking Avandamet (see Metformin and Alcohol).
- Since liver disease (including liver failure and cirrhosis) can increase your risk of lactic acidosis, you should not take Avandamet if your liver is not functioning normally. Also, your kidney function needs to be monitored while you are taking Avandamet. This means that you should have blood tests that check your kidneys before you start Avandamet and then at least once every year. If your kidney function is very poor, you should not take Avandamet, due to increased risk of lactic acidosis.
- Taking metformin (one of the active ingredients in Avandamet) and contrast dye at the same time can increase your risk of kidney damage. Contrast dye is used for certain radiology procedures, including some x-rays, CT scans, and heart catheterizations (see Metformin and Contrast Medium for more information). Also, Avandamet should be temporarily stopped for most major surgeries and should be restarted when you are eating normally again.
- Fever, infections, injury, or surgery can temporarily increase your blood sugar, even in people with well-controlled diabetes. Avandamet may not be enough to treat your diabetes at these times, and the use of insulin may be required. Contact your healthcare provider if you have a fever, infection, injury, or will be having surgery. Also, make sure you know the symptoms of high blood sugar and how to check your blood sugar levels (see Avandamet and Blood Sugar for more information).
- Let your healthcare provider know if you have an illness that causes severe vomiting, diarrhea, or fever, or if you drink a much lower amount of liquid than normal. These conditions can lead to severe dehydration (loss of water in your body). You may need to stop taking Avandamet for a short time.
Avandamet 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 Avandamet, women taking this drug may be at higher risk for broken bones. Other studies suggest that men taking rosiglitazone may also be at a higher risk for fractures.
- Avandamet can decrease your levels of vitamin B12. Your healthcare provider should monitor your vitamin B12 levels, especially if you have a vitamin B12 deficiency (including pernicious anemia).
- There have been reports of Avandamet causing macular edema (a condition of the eye). Tell your healthcare provider if you have any vision changes.
- If you are a premenopausal woman who has infertility problems (due to lack of ovulation), Avandamet may increase your for chance of ovulation (and pregnancy). Talk to your healthcare provider about birth control options if you would like to avoid pregnancy while taking Avandamet.
- Avandamet may cause increased liver enzymes. Very rarely, this has led to liver damage. It is recommended that liver enzymes be checked in all people before starting Avandamet and should be checked again periodically. Liver enzymes are checked using a blood test. Avandamet should not be started in people with high liver enzymes. Avandamet should be stopped if liver enzymes increase and continue to stay high, as this may be a sign of liver damage.
- Avandamet can interact with certain medications (see Avandamet Drug Interactions).
- Avandamet is considered a pregnancy Category C medication. This means that it may not be safe to use during pregnancy. Talk to your healthcare provider about the risks of benefits of using Avandamet during pregnancy (see Avandamet and Pregnancy for more information).
- It is not known if Avandamet passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, be sure to talk with your healthcare provider about this.
- Rarely, Avandamet can cause low blood sugar (hypoglycemia), usually when it is combined with other diabetes drugs. This has been more common in elderly people and in people with adrenal, pituitary, liver, or kidney problems. It is also more likely to occur 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 Metformin and Blood Sugar for more information).