Japan - Pioglitazone hydrochloride (Actos®) was approved for marketing in 1999 for the treatment of diabetes and is considered to improve resistance to insulin. The Ministry of Health and Welfare in Japan has received five case reports of cardiac failure, four out of five serious, associated with the use of the drug, and instructed the manufacturer to revise the labelling and to issue a letter to health professionals to draw their attention to cardiac failure during treatment.
Case reports show that oedema and rapid weight gain - potentially due to plasma volume expansion - have occurred in patients during the use of pioglitazone and this has triggered cardiac failure.
As reflected in the revised labelling, pioglitazone is now contraindicated in patients with cardiac failure or a medical history of cardiac failure. Special attention should be paid to oedema and rapid weight gain during the treatment of patients and patients should consult their physician immediately in the event of any symptoms occurring.
1. MHW Emergent Safety Information dated 5 October at http://www.mhw.go.jp
2. Dear Doctor letter from Takeda Chemical Industries, Ltd. at http://www.pharmasys.gr.jp