ADR that result in revision of patient information
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| The United States: Testosterone Products: Drug Safety Communication - FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke |
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FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.
Based on the available evidence from studies and expert input from an FDA Advisory Committee meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not.
Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. Health care professionals should make patients aware of the possible increased cardiovascular risk when deciding whether to start or continue a patient on testosterone therapy. Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as chest pain, shortness of breath or trouble breathing, weakness in one part or one side of the body, or slurred speech.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm436280.htm
In Hong Kong, there are eight registered pharmaceutical products containing testosterone and they 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 on 4 February 2014, 12 April 2014, 11 October 2014 and 22 November 2014. 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 not received any adverse drug reaction reports on the drug related to cardiovascular complications. The matter was discussed by the Registration Committee of the Pharmacy and Poisons Board on 17 February 2015. The Committee noted that DH had informed the registration certificate holders to include cardiovascular warnings on their testosterone products, and 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/ Wednesday, March 4, 2015
Issued at HKT 16:00
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