Vitamin B12 deficiency: Metformin may lower Vitamin B12 levels. Monitor hematologic parameters annually.
Warnings and Precautions—for OSENI
Congestive heart failure: Fluid retention may occur and can exacerbate or lead to congestive heart failure. Combination use with insulin and use in congestive heart failure NYHA Class I and II may increase risk. Monitor patients for signs and symptoms.
Edema: Dose-related edema may occur. Use with caution in patients with edema.
Fractures: Increased incidence in female patients. Apply current standards of care for assessing and maintaining bone health.
Bladder cancer: Data suggest an increased risk of bladder cancer in pioglitazone users. Data also suggest that the risk increases with duration of use. Do not use OSENI in patients with active bladder cancer. Use caution when using in patients with a prior history of bladder cancer. Tell patients to promptly report any sign of hematuria or other symptoms such as dysuria or urinary urgency as these may be due to bladder cancer.
Macular edema: Macular edema has been reported in some patients taking pioglitazone. Recommend regular eye exams. Instruct patients to report any visual changes promptly.
Ovulation: Therapy with pioglitazone may result in ovulation in some premenopausal anovulatory women.
Warnings and Precautions—for NESINA, KAZANO, and OSENI
Acute pancreatitis: There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue NESINA, KAZANO, or OSENI.
Hypersensitivity: There have been postmarketing reports of serious hy
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