其 他 安 全 警 示
|
| |
| Australia: Pioglitazone and risk of bladder cancer (English Only) |
| |
The TGA is advising health professionals and consumers that use of the diabetes medicine, pioglitazone, for more than a year may be associated with an increased risk of bladder cancer. This advice is partly based on the results of a study in the United States indicating a possible increase in bladder cancer risk among patients taking pioglitazone for more than two years, compared with diabetes patients who are not taking the medicine1. The study found an increased risk of bladder cancer in patients with the longest exposure to pioglitazone. The chance of developing bladder cancer in patients on pioglitazone for greater than 24 months was 1.4 times the chance in diabetic patients not on pioglitazone. The Product Information (PI) and Consumer Medicine Information (CMI) for the Actos brand of pioglitazone have been updated and the sponsor of the Actos brand has also written to health professionals advising them of the changes to the Product Information. The TGA is working with the other sponsors of pioglitazone medicines to update the PI and CMI to include the results of the United States study.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/alerts-medicine-pioglitazone-110718.htm
In Hong Kong, there are 24 pioglitazone-containing products registered and are prescription medicines. The above safety news has been released by the European Medicines Agency, US Food and Drug Administration and Health Canada and was posted on the website of Pharmaceutical Service on 10 June 2011, 16 June 2011, 18 June 2011 and 24 June 2011. A letter to healthcare professionals has been issued on 16 June 2011. As reported on 16 June 2011, the matter will be discussed in the coming meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Monday, July 18, 2011
Issued at HKT 12:30
|
| |
|
