What are the contraindications for Pioglitazone (Actos) in patients?

From the Guidelines

Actos (pioglitazone) is contraindicated in patients with established New York Heart Association (NYHA) Class III or IV heart failure, active bladder cancer or a history of bladder cancer, and those with known hypersensitivity to pioglitazone or any components of the medication. According to the most recent evidence from 1, pioglitazone is associated with an increased risk of heart failure and fluid retention, and should not be used in patients with heart failure. Additionally, the evidence from 1 suggests that pioglitazone may increase the risk of bladder cancer, particularly with long-term use. The contraindications for pioglitazone also include active liver disease, as stated in 1, and severe osteoporosis and fractures. Some key points to consider when prescribing Actos include:

• Assessing cardiac status, liver function, and bladder cancer risk factors before initiating treatment
• Regular monitoring of liver enzymes, signs of heart failure, and bladder symptoms during treatment
• Considering alternative diabetes medications for patients with contraindications
• Being aware of the potential for pioglitazone to cause or worsen fluid retention, potentially exacerbating heart failure
• Counseling patients on the potential risks and benefits of pioglitazone, including the risk of bladder cancer and fractures.

From the FDA Drug Label

Initiation of ACTOS in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated ACTOS is contraindicated in patients with known hypersensitivity to this product or any of its components.

Actos is contraindicated in patients with:

• Established NYHA Class III or IV heart failure
• Known hypersensitivity to the product or any of its components 2

From the Research

Contraindications of Actos (Pioglitazone)

• Actos is contraindicated in patients with:
  • NYHA Class III or IV heart failure 3, 4
  • Active bladder cancer or a history of bladder cancer 5
  • Severe hepatic impairment 5
• The use of pioglitazone is also not recommended in patients with:
  • Systolic dysfunction or heart failure, as it may exacerbate the condition 3, 4
  • A history of fluid retention or edema, as pioglitazone may cause fluid retention 5, 3, 4
• Patients with type 2 diabetes and mild cardiac disease should be monitored closely when taking pioglitazone, as it may cause fluid retention and exacerbate heart failure 4
• Pioglitazone is not recommended for patients with a history of bone fractures, as it may increase the risk of fractures, particularly in female patients 5