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pioglitazone (cont.)

To date, no formal studies to evaluate drug interactions of pioglitazone with other drugs have been conducted. Nevertheless, because it interacts with the liver enzymes that eliminate some other drugs, there is the potential for pioglitazone to increase the elimination of such drugs as erythromycin, calcium channel blockers (e.g., Cardizem), cisapride (Propulsid), corticosteroids, cyclosporine, tacrolimus, triazolam (e.g., Halcion), trimetrexate, and HMG-CoA reductase inhibitors (e.g., Lipitor). This would reduce their effectiveness.

Since another thiazolidinedione antidiabetic drug has been associated with liver injury, it is recommended that periodic monitoring of liver-related side effects and liver function be done in patients taking pioglitazone. Side effects while taking pioglitazone which may be due to liver injury include nausea, vomiting, abdominal pain, fatigue, anorexia (loss of appetite), or dark urine. Blood liver tests also are recommended during pioglitazone therapy.

Studies in the laboratory have shown that an anti-fungal drug, ketoconazole (Nizoral), prevents the elimination of pioglitazone. This could lead to increased levels of pioglitazone and hypoglycemia (seriously reduced level of sugar in the blood). Therefore, the manufacturer of pioglitazone recommends more frequent monitoring of blood sugar among patients taking both pioglitazone and ketoconazole or the drugs related to ketoconazole, fluconazole (Diflucan) and itraconazole (Sporanox).

Pioglitazone may cause ovulation in women who have stopped ovulating if they are pre-menopausal and insulin resistant. This may lead to pregnancy.

Since studies of pioglitazone excluded patients with heart disease classified by the New York Heart Association (NYHA) as Class III and IV (more serious disease), it is not known how diabetics with serious heart disease will respond to pioglitazone, particularly since it may lead to fluid accumulation and heart failure.

For women (but not men) taking pioglitazone, there is an associated small risk of fracture of the distal bones of the arm and leg, amounting to approximately one additional fracture (as compared with placebo or other drugs) for every 100 years' use of pioglitazone.  The reason for this association is not known.

Medical Editor: Jay Marks, M.D.

Reference: FDA Prescribing Information


Last Editorial Review: 4/2/2007




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