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CONGESTIVE HEART FAILURE: Thiazolidinediones, including pioglitazone, cause or exacerbate congestive heart failure in some patients. After initiation of pioglitazone, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, tired, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of pioglitazone must be considered.
Pioglitazone is not recommended in patients with symptomatic heart failure. Initiation of pioglitazone in patients with established NYHA Class III or IV heart failure is contraindicated.
Risk of bladder cancer: This drug may increase risk of bladder cancer.
Should not be used in patients with active bladder cancer.
Use with caution, benefits versus risks should be considered in patients with a prior history of bladder cancer or in patients at risk of bladder cancer.
Should any symptom or sign of haematuria, urinary incontinence, dysuria, back pain or abdominal pain occur, consult physician.
Based on Thai Ministry of Public Health Announcement: 1. Do not use pioglitazone in patients with severe degree of heart failure (established NYHA Class III or IV). This drug may cause congestive heart failure. If there are symptoms of dyspnea, feeling tired easily, rapid weight gain or severe edema after using this drug, consult physician immediately.
2. Concomitant use with NSAIDs, Coxib or insulin will increase risk of edema and congestive heart failure. Must use with caution.
3. This drug may increase risk of bladder cancer.
4. Should not be used in patients with active bladder cancer.
5. Use with caution, benefits versus risks should be considered in patients with a prior history of bladder cancer or in patients at risk of bladder cancer. Use of pioglitazone longer than one year may be associated with increased occurrence of bladder cancer.
6. Should any symptoms or signs of haematuria, urinary incontinence, dysuria, back pain or abdominal pain occur, consult physician.
