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Actos
Generic Name: Pioglitazone Hydrochloride
Drug Category: TZD
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 5 years.
| Approved Uses |
|
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. ACTOS should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ACTOS or any other antidiabetic drug. Thiazolidinediones, including ACTOS, cause or exacerbate congestive heart failure in some patients. After initiation of ACTOS, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of ACTOS must be considered. ACTOS is not recommended in patients with symptomatic heart failure. Initiation of ACTOS in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated. ACTOS, like other thiazolidinediones, can cause dose-related fluid retention when used alone or in combination with other antidiabetic medications and is most common when ACTOS is used in combination with insulin. Fluid retention may lead to or exacerbate congestive heart failure. May increase the risk of bladder cancer. Do not use in patients with active bladder cancer. Use caution when using in patients with a prior history of bladder cancer. Postmarketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. If liver injury is detected, promptly interrupt ACTOS and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. The risk of fracture should be considered in the care of patients, especially female patients, treated with ACTOS and attention should be given to assessing and maintaining bone health according to current standards of care.The majority of fractures observed in female patients were nonvertebral fractures including lower limb and distal upper limb. Macular edema has been reported in postmarketing experience in diabetic patients who were taking ACTOS or another thiazolidinedione. Dose-related weight gain occurs when ACTOS is used alone or in combination with other antidiabetic medications. ACTOS may cause decreases in hemoglobin and hematocrit. These changes primarily occurred within the first 4 to 12 weeks of therapy and remained relatively constant thereafter. Co-administration of ACTOS and gemfibrozil, a strong CYP2C8 inhibitor, increases pioglitazone exposure approximately 3-fold. Therefore, the maximum recommended dose of ACTOS is 15 mg daily when used in combination with gemfibrozil or other strong CYP2C8 inhibitors. An inducer of CYP2C8 (e.g., rifampin) may significantly decrease the exposure (AUC) of pioglitazone. Therefore, if an inducer of CYP2C8 is started or stopped during treatment with ACTOS, changes in diabetes treatment may be needed based on clinical response without exceeding the maximum recommended daily dose of 45 mg for ACTOS. A decrease in the exposure of pioglitazone and its active metabolites were noted with concomitant administration of pioglitazone and topiramate. The clinical relevance of this decrease is unknown; however, when ACTOS and topiramate are used concomitantly, monitor patients for adequate glycemic control. Limited data with ACTOS in pregnant women are not sufficient to determine a drug associated risk for major birth defects or miscarriage. Animal studies: delayed parturition, reduced embryo-fetal viability, delayed postnatal development, and decreased body weight. There is no information regarding the presence of pioglitazone in human milk, the effects on the breastfed infant, or the effects on milk production. Pioglitazone is present in rat milk. |
| Off-label Uses |
|
• Use in patients under the age of 18 years of age. GoToSource • Plaque psoriasis. GoToSource • Polycystic ovary syndrome. GoToSource • Autism. GoToSource • Type 1 diabetes or diabetic ketoacidosis. GoToSource • Lupus. GoToSource • Biopsy-proven nonalcoholic steatohepatitis. GoToSource • Non-classic adrenal hyperplasia. GoToSource • Parkinson’s disease. GoToSource • Syndrome of extreme insulin resistance. GoToSource • Malignant gliomas. GoToSource • Nonalcoholic fatty liver disease. GoToSource • Prevention of atrial fibrosis and atrial fibrillation. GoToSource • Short-term treatment for moderate-to-severe major depressive disorder. GoToSource • Lichen planopilaris. GoToSource • Acute lung injury. GoToSource • Alzheimer’s disease. GoToSource • Metabolic syndrome. GoToSource • Ischemic stroke therapy. GoToSource • Lipid and glucose abnormalities in patients with schizophrenia. GoToSource |
| Adverse Events |
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Severe mitral and aortic regurgitation. GoToSource Arm, hand and foot fractures. GoToSource Bladder cancer. GoToSource Diabetic macular edema. GoToSource Edema and weight gain. GoToSource Pneumonia and lower respiratory tract infections. GoToSource Liver failure. GoToSource Congestive heart failure and pulmonary edema. GoToSource |
| Litigation |
|
Lawsuits filed for death, heart attacks, hepatic failure, bladder cancer and fractures. |
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