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FDA approves labeling changes for pioglitazone due to bladder cancer risk
The FDA has approve updated drug labels for pioglitazone-containing medicines to include a safety warning that the use of pioglitazone for more than 1 year may be associated with an increased risk for bladder cancer.
According to the new drug label, health care professionals should:
- Not use pioglitazone in patients with active bladder cancer.
- Use pioglitazone with caution in patients with a prior history of bladder cancer.
In addition, patients are encouraged to contact their health care professional if experiencing any sign of blood in the urine or symptoms such as new or worsening urinary urgency or pain on urination since starting pioglitazone (Takeda). These symptoms may be related to bladder cancer.
According to the FDA, health care professionals and patients can access the latest drug labels for pioglitazone-containing medicines at:
- Actos (pioglitazone)
- Actoplus Met (pioglitazone/metformin)
- Actoplus Met XR (pioglitazone/metformin extended-release)
- Duetact (pioglitazone/glimepiride)
These labeling changes were previously communicated on June 15.
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