The recent label of diabetes drug Actos has gone through a big change and is updated. The current Product Monograph for Actos contains the following new or updated information:
- Actos should not be used in patients with any stage of heart failure (Contraindications section)
- Actos is not approved for use with metformin and a sulfonylurea.
People with diabetes are at increased risk of developing heart failure or may have pre-existing heart disease, and are more likely to experience cardiovascular adverse events. Actos may further increase the risk of heart failure and should not be used by diabetics with any history of heart failure.
Patients who experience signs of heart failure including unusually rapid weight gain, swelling, weakness, or shortness of breath while taking Actos should immediately report these signs to their health care provider. While previous labelling addressed the risk of heart failure, a safety assessment completed by Health Canada on Actos identified the need for new restrictions to better manage the risk.