Safety advice on particular drugs or classes of drugs
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| European Union: Review of testosterone-containing medicines started |
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The European Medicines Agency has started a review of testosterone-containing medicines, mainly used in men who do not produce enough testosterone (a condition known as hypogonadism).
The review was triggered by the Estonian medicines agency, the State Agency of Medicines, over concerns about side effects of medicines containing testosterone on the heart. The safety concerns were raised following the recent publication of a study suggesting that the use of testosterone increases the risk of myocardial infarction (heart attack) in men aged over 65 years, as well as in younger men with pre-existing heart disease. This study follows other studies including the Veterans Health Care Study, which suggests that men with pre-existing heart disease who received treatment with testosterone had a higher risk of heart problems than men who did not receive testosterone.
The European Medicines Agency will now review all available data on the benefit-risk balance of testosterone-containing medicines (in men and women), and issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.
While the review is ongoing, patients should speak to their doctor or pharmacist if they have any questions or concerns.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002069.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 8 registered pharmaceutical products containing testosterone. All of the products are prescription only medicines. The US Food and Drug Administration (FDA) also started investigating the risk of cardiovascular events of testosterone products and the related news was posted on the Drug Office website on 4 February 2014. The Department of Health will remain vigilant on any safety updates of the drug and actions taken by overseas regulatory authorities of any action deemed necessary.
Ends/ Saturday, April 12, 2014
Issued at HKT 12:00
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