Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.
HEALTH CANADA ADVISORY
April 19, 2012
Health Canada has issued new information concerning the use of pioglitazone. To read the full report, visit Health Canada's web site at www.hc-sc.gc.ca.
Bladder: Taking pioglitazone may be associated with an increased risk of bladder cancer. If you experience symptoms such as blood or red color in urine, an urgent need to urinate, pain while urinating, or pain in the back or lower abdomen, talk to your doctor right away.
Fractures: Pioglitazone has been associated with an increased incidence of bone fracture for female patients. You and your doctor should consider the risk of fractures. Talk to your doctor if you have any concerns.
Heart failure: Pioglitazone can cause fluid buildup in the body, which may lead to congestive heart failure. This medication should not be used by anyone who has any degree of heart failure, or anyone who is at risk of heart failure (including people with swelling due to fluid buildup). If you develop fluid buildup or swelling, shortness of breath, fatigue, or excessive weight gain while taking this medication you should consult your doctor immediately.
Liver: Although liver problems have not been observed with pioglitazone, another similar medication has caused liver problems in a small number of people. You should report any signs of liver problems (abdominal or stomach pain, dark urine, loss of appetite, nausea or vomiting, unusual tiredness or weakness, or yellow eyes or skin) to your doctor at once.
Use with other antidiabeties medications: Pioglitazone should not be used with insulin. It should not be used in combination (i.e., triple therapy) with both metformin and a sulfonylurea (e.g., glyburide, glicazide).
Pregnancy: Pioglitazone has not been studied for use by pregnant women. This medication should not be used during pregnancy. In general, blood sugar should be controlled during pregnancy by using insulin injections. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if pioglitazone passes into breast milk. The use of pioglitazone is not recommended while breast-feeding. Women who are taking pioglitazone should inform their doctor if they are breast-feeding or are intending to breast-feed.
The safety and effectiveness of using this medication have not been established for children.