其 他 安 全 警 示
|
| |
| Canada: Health Canada reviewing diabetes drug pioglitazone (Actos) and potential risk of bladder cancer (English Only) |
| |
In light of studies suggesting an increased risk of bladder cancer with the diabetes drug pioglitazone, as well as actions taken by other regulatory agencies, Health Canada is informing healthcare professionals and Canadians that it is undertaking a review of the drug's status.
Pioglitazone is sold in Canada under the brand name "Actos" in addition to generic forms of the drug. It is used by itself or in combination with other diabetes drugs to control blood sugar levels in diabetic patients, when diet and exercise have failed.
Post-marketing reports of bladder cancer have been reported very rarely with the use of pioglitazone. This information is included in the Canadian Product Monograph. Health Canada has been closely monitoring this potential risk, and has been reviewing all relevant studies on an ongoing basis. Health Canada is taking these studies, including their strengths and limitations, into account as to monitor pioglitazone safety.
Should the on-going review identify new safety information, Health Canada will take appropriate action as necessary. This can include updating Canadians with new recommendations regarding pioglitazone and the potential risk of bladder cancer.
The benefits of pioglitazone are considered to outweigh the risks when used as directed in the Canadian Product Monograph. Patients with questions or concerns about their diabetes treatment should talk to their physician or pharmacist.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_79-eng.php
Situation in Hong Kong: There are 24 pioglitazone-containing products (including Actos) registered and are prescription medicines. Press releases regarding Actos were issued on 20 September 2010, 10 and 16 June 2011 and were posted on Pharmaceutical Service’s website. A letter to healthcare professionals has been issued on 16 June 2011. The matter will be discussed in the coming meeting of the Registration Committee of the Pharmacy and Poisons Board.
|
| |
|
