Actos (pioglitazone hydrochloride), an oral anti-diabetic drug, is authorized in Canada (and in the United States) to help decrease the blood glucose levels not controlled by diet and exercise alone, in patients who suffer from type 2 diabetes mellitus. ACTOS (pioglitazone hydrochloride) can also be taken with sulfonylurea or metformin when diet and exercise and Actos result in insufficient glycemic control.
Health Canada recently completed a safety study on Actos based on the available data, which showed that there was a correlation between an increased risk of bladder cancer and use of Actos. The Product Monograph (PM) for Actos, a writing that specifies the kinds and amounts of ingredients a drug or class of drugs may contain, the directions for the drug’s use, the conditions in which it may be used, and the contraindications to its use (Thefreedictionary) was updated to reflect the potential increase in the risk of bladder cancer in patients treated with Actos.
According to Health Canada these were added to the PM for Actos:
- Findings from new studies reveal that there is a potential increased risk of bladder cancer in
patients treated with pioglitazone-containing products.
- ACTOS (pioglitazone hydrochloride) is now contraindicated in patients with active bladder
cancer, a history of bladder cancer or uninvestigated macroscopic haematuria.
- Any macroscopic haematuria should be investigated before starting pioglitazone therapy.
- Risk factors for bladder cancer should be assessed before initiating treatment with
pioglitazone (risks include age, smoking, family history of bladder cancer, exposure to
chemicals in the workplace, certain cancer treatments and radiation therapy).
Takeda, the manufacturer of Actos signed the release as well.
Source: Health Canada