Other safety alerts
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| Singapore: Testosterone and risk of cardiovascular events |
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HSA would like to bring to the attention of healthcare professionals, the overseas signals of cardiovascular (CV) events that have been associated with the use of testosterone-containing products. Safety reviews conducted by international regulatory agencies have concluded that the signal of CV risk remains weak and further investigations by the manufacturers, such as the conduct of a well-designed clinical trial and close monitoring of these safety events, are necessary to confirm this risk.
Testosterone is a steroid hormone that plays a role in the development of androgenic and anabolic processes. It is mainly indicated for replacement therapy in males with primary and secondary hypogonadal disorders. Some of the testosterone-containing products are also indicated for osteoporosis caused by androgen deficiency, or for masculinisation in female to male transsexuals. Testosterone was first licensed in Singapore in 1990, and there are currently seven testosterone-containing products in different dosage forms, ranging from oral capsules to subcutaneous implants.
Reviews on the CV risk of testosterone have been conducted by the US FDA, EMA, Health Canada and New Zealand Medsafe. Details of the reviews can be found in the HSA's website.
HSA has received one local ADR report of MI associated with the use of testosterone. No local ADR reports of VTE associated with the use of testosterone have been received.
HSA has also consulted local experts (urologists and cardiologists) regarding the signal of CV risk with testosterone. Some of the experts were of the opinion that methodological limitations and biases may have impacted the findings of the observational studies mentioned in overseas reviews. HSA is working with the companies to ensure that the warnings and precautions relating to CV events are adequately highlighted across the package insert (PI) of testosterone-containing products.
HSA will continue to monitor international and local developments regarding the CV risk of testosterone-containing products and will update healthcare professionals of any new safety findings.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../testosterone-andriskofcardiovascularevents.html
In Hong Kong, there are eight registered pharmaceutical products containing testosterone or methyltestosterone, and are prescription-only medicines. DH noted that FDA and EMA have started to review the risk of cardiovascular events of testosterone products, and the related news was posted on the website of Drug Office in 2014 and 2015. In July 2014, Health Canada completed a safety review on the possible cardiovascular problems with testosterone products, and worked with their manufacturers to update the Canadian product labels with the safety warnings, and the news was posted on the Drug Office website on 16 July 2014. Letters to inform local healthcare professionals on the above safety warnings and the latest EU PRAC recommendations were issued on 16 July 2014 and 13 October 2014.
So far, DH has received one case of adverse drug reaction on testosterone, and it was not related to cardiovascular complications.
The matter was discussed by the Registration Committee of the Pharmacy and Poisons Board (the Committee) on 17 February 2015. The Committee noted that DH had informed the registration certificate holders to include cardiovascular warnings on their testosterone products. As previously reported, DH is still processing their applications to update the new warnings. DH will continue to follow up with these registration certificate holders and will keep vigilant on any further announcements on the products issued by other overseas health authorities.
Ends/ Thursday, October 08, 2015
Issued at HKT 15:00
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