ADR that result in revision of patient information
|
| |
| Canada: Finasteride (Proscar, Propecia) and dutasteride (Avodart, Jalyn) may increase the risk of high-grade prostate cancer |
| |
Health Canada is informing health professionals and the public that the prescription drugs finasteride and dutasteride may be associated with an increased risk of developing a serious form of prostate cancer known as high-grade prostate cancer. High-grade prostate cancer is an aggressive type of prostate cancer that grows and spreads more quickly than low-grade prostate cancer. This type of cancer is rare, and the increased risk seen with finasteride and dutasteride drugs is still considered very small. The new safety information is based on Health Canada's review of two large international clinical trials: the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. The trials showed that the long-term daily use (over 4 years) of finasteride (5 mg) and dutasteride in men aged 50 years and older was associated with a small but statistically significant increased risk of high-grade prostate cancer. The 1 mg finasteride strength (Propecia) was not included in these trials but a potential risk has not been ruled out. The purpose of the clinical trials was to provide evidence in support of a new use for finasteride and dutasteride: to prevent prostate cancer. Both trials showed that the possible benefits of these drugs in preventing low-grade prostate cancer are small relative to the risk of developing high-grade prostate cancer. Finasteride and dustasteride are not approved for the prevention of prostate cancer in Canada. The Canadian labels for the brand name drugs have been updated to inform about the increased risk of high-grade prostate cancer associated with these drugs and to emphasize that these drugs are not approved for the prevention of prostate cancer. Updates to the generics will follow.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_38-eng.php
In Hong Kong, there are 21 and 2 registered pharmaceutical products containing finasteride and dutasteride respectively. All are prescription-only medicines. The above safety news has been released by the US FDA and Singapore HSA and was posted on the website of Drug Office on 10 June 2011 and 4 October 2011. A letter for healthcare professionals was issued on 10 June 2011. The matter was discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board on 6 September 2011. The Committee decided that the sales pack labels of products containing the concerned ingredients should include the information that the use of the product may increase the risk of high-grade prostate cancer, and the product is not approved for the prevention of prostate cancer.
Ends/ Tuesday, March 20, 2012
Issued at HKT 12:30
|
| |
|
