Actos (pioglitazone, also marketed in the US as Actoplus Met, and Duetact) is a newer drug of the class thiazolidinedione. It is used by itself (monotherapy) or in combination with other drugs (typically insulin, sulfonylurea, or metformin) for the treatment of diabetes mellitus type 2. The US Food and Drug Administration (FDA) approved Actos for this use in July 1999.
Soon after the FDA approval, however, Rezulin, another thiazolidinedione, was removed from the market due to several reports of fatal liver disease in those who had taken it. Then additional cases of congestive heart failure in people taking Actos or Avandia prompted the American Diabetes Association and the American Heart Association to issue recommendations with regard to the use of Actos, and a warning of an increased risk of developing congestive heart failure in diabetics with heart disease or kidney problems who take Actos.
In August, 2007, the FDA issued an alert highlighting important revisions to the prescribing information for Actos, including a new boxed warning and revisions to the precautions, warnings, and contraindications. In December 2008, the FDA then began requiring new diabetes drugs to be screened for heart risks before they can be approved. But the requirement does not apply to Actos or other diabetes drugs already on the market. More recently, research published in PloS Medicine suggests that the use of Actos and Avandia may increase the risk for bone fracture.
There are numerous side effects associated with the use of Actos. Adverse effects for which immediate medical attention should be sought include:
- irregular breathing, troubled breathing, or shortness of breath
- chest tightness or pain
- extreme fatigue
- irregular heartbeat
- dilated neck veins
- swelling of face, fingers, feet, or lower legs
- problems with teeth
- decreased urine output
- weight gain
If you or a loved one has been injured as a result of taking Actos or another diabetes medication, you may be entitled to compensation. Contact a qualified pharmaceutical injury attorney for an evaluation of your case.