The US FDA has released results of its review of Glizone and bladder cancer and concluded that the data suggests use of this drug may be linked to an increase risk of bladder cancer. A 10-year prospective cohort study in diabetic patients performed by the manufacturer (n=158,918 never users; n=34,181 ever users) identified 1075 newly diagnosed cases of bladder cancer in never users and 186 cases in ever users. The fully adjusted hazard ratio (HR) showed Glizone use was not associated with an increased risk (HR 1.06 (95% confidence interval 0.89 to 1.26). And while a modest trend towards higher risk with increasing duration was observed, this trend was not statistically significant. Compared to the interim 5-year results, the 10-year results found weaker associations that were not statistically significant. However, there are studies that have shown a statistically significant association between exposure to this drug and bladder cancer and an association between cumulative dose or cumulative duration of exposure and bladder cancer. Overall, this drug may be associated with an increase in the risk of urinary bladder tumors, however there is insufficient data to determine whether this drug is a tumor promoter for urinary bladder tumors.
Uncommon (0.1% to 1%): Bladder cancer
How to use Glizone-Metformin
Read the Medication Guide provided by your pharmacist before you start taking Glizone/metformin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually once or twice daily with meals to decrease stomach upset. Drink plenty of fluids while taking this medication unless otherwise directed by your doctor.
The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To reduce your risk of side effects (such as upset stomach), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.
Take this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day.
If you are already taking another diabetes medication, follow your doctor's directions carefully for stopping/continuing the old drug and starting this medication.
Check your blood sugar regularly as directed by your doctor. Keep track of the results, and share them with your doctor. Tell your doctor if your blood sugar measurements are too high or too low. Your dosage/treatment may need to be changed. It may take up to 2 to 3 months before the full benefit of this drug takes effect.
Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:
Urgent advice: Contact your doctor straight away if you take too much Glizone
If you take Glizone with other diabetes medicines, taking too many tablets may cause low blood sugar.
If you think you have low blood sugar, have some food or drink that quickly gets sugar into your bloodstream such as sugar cubes or fruit juice. This type of sugar won't last long in your blood. You may also need to eat a starchy carbohydrate, like a sandwich or some biscuits.
- Patients with type 2 diabetes cannot make enough insulin, and the cells of their body respond less to the insulin that is produced. Since insulin is the hormone that stimulates cells to remove glucose from the blood, the reduced amount of insulin and its reduced effect cause cells to take up less glucose from the blood and the level of glucose in the blood to rise. Glizone often is referred to as an "insulin sensitizer" because it attaches to the insulin receptors on cells throughout the body and causes the cells to become more sensitive (more responsive) to insulin. As a result, more glucose is removed from the blood, and the level of glucose in the blood falls. At least some insulin must be produced by the pancreas in order for Glizone to work. Glizone also lowers the level of glucose in the blood by reducing the production and secretion of glucose into the blood by the liver. In addition, Glizone may alter the blood concentrations of lipids (fats) in the blood. Specifically, it decreases triglycerides and increases the "good" (HDL) cholesterol.
1. About Glizone
Glizone is a medicine used to treat type 2 diabetes.
Type 2 diabetes is an illness where the body doesn't make enough insulin, or the insulin that it makes doesn't work properly. This can cause high blood sugar levels (hyperglycaemia).
Glizone helps to control your blood sugar levels by helping your body make better use of the insulin it produces.
Glizone is only available on prescription. It comes as tablets.
It also comes as tablets containing a mixture of Glizone and metformin. Metformin is another medicine used to treat diabetes.
Glizone carries a black-box warning because it may cause or worsen congestive heart failure.
Before taking Glizone, tell your doctor about any conditions you've had that may be related to or affect the heart, such as:
Tell your doctor immediately or get emergency medical attention if you experience symptoms of congestive heart failure, which may include:
- Shortness of breath
- Swelling of the arms, hands, feet, ankles, lower back, or lower legs
- Stomach swelling or pain
- Waking up during the night feeling short of breath
- Inability to sleep while laying flat
- Frequent dry cough or wheezing
- Fast or racing heartbeat
- Confusion or difficulty thinking clearly
- Increased fatigue
- Difficulty walking or exercising
- Significant weight gain in a short period of time
Before taking this medication, also tell your doctor if you have or have ever had:
- Bladder cancer
- Diabetic eye disease
- Kidney disease
Glizone may cause liver problems. Tell your doctor if you've ever had liver disease.
Stop taking the medicine and call your healthcare provider right away if you experience:
- Loss of appetite
- Pain in the upper right part of your stomach
- Flu-like symptoms
- Dark urine
- Unusual bruising or bleeding
- Yellowing of the eyes or skin
- Profound lack of energy
Glizone may also increase a woman's chances of experiencing a broken bone. Tell your doctor right away if you experience any kind of bone pain.
Also, tell your healthcare providers that you're taking Glizone before having any type of surgery, including a dental procedure.
You shouldn't take Glizone if you have type 1 diabetes (the body doesn't produce any insulin) or diabetic ketoacidosis (a dangerous condition that can occur if high blood sugar is untreated).
Glizone may cause changes in your blood sugar. You should know the symptoms of high (hyperglycemic) or low (hypoglycemic) blood-sugar episodes and be prepared to treat them.
Tell your physician if you experience an illness, fever, injury, or unusual stress while taking Glizone, because these can change your blood sugar and the dosage you need.
Glizone controls diabetes, but it doesn't cure it. Continue to take it even if you feel well.
It may take two weeks for your blood sugar to decrease and up to three months to feel the full effects of this drug.
Your physician will probably want to check your glucose levels often while you are taking Glizone.
Always wear a diabetic ID bracelet to be sure you get proper treatment in case of an emergency.
What other drugs will affect Glizone (Actos)?
Tell your doctor if you use insulin. Taking Glizone while you are using insulin may increase your risk of serious heart problems.
Many drugs can affect Glizone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.