The European Medicines Agency has announced that it will reassess the benefit-risk of testosterone, in particular because of a study which showed an increased risk of heart attack.
Testosterone supplementation could put some men’s heart and blood vessels at risk. In any case, this is the potential risk that the European Medicines Agency (EMA) wishes to clarify. Indeed in various press releases published on Friday, the agency said that its Pharmacovigilance Risk Assessment Committee (PRAC) had started to reassess the benefit / risk ratio of testosterone. Although less prescribed than in the United States where about 3% of men absorb this hormonal product, Europe therefore wants to ensure that those who take it because they have a deficit or to increase their muscle mass, or to boost their sexual or athletic abilities do not risk their health. The PRAC was therefore seized of the matter following several recent scientific publications pointing the finger at a possible cardiovascular risk.
a heart risk suggested in several studies
The latest study to have alerted the scientific community to this risk is an analysis published last January in the journal Plos One. Funded by the American Institutes of Health (NIH), this work had followed 56,000 men between 2008 and 2010 divided into two groups. The first was made up of men over 65 who used testosterone but had no history of heart disease. The second group consisted of younger men with a known history of heart disease. These researchers, therefore, compared the rates of heart attacks in these two populations. As a result, men aged 65 and over, taking testosterone, had twice as many heart attacks in the months following the start of treatment. A similar finding in men under 65 with a previous diagnosis of heart disease. In addition, another study published in JAMA in November 2013 found that testosterone substitution increased the risk of death, myocardial infarction and ischemic stroke by 29% in a population of men aged 60 to 64. years.
The United States is also investigating this risk
This European re-evaluation comes as the US Food and Drug Administration (FDA) announced two months ago that it was also investigating the association between taking supplemental testosterone and cardiac risk. One of the questions to which the various research teams are trying to answer is in particular to know whether it is the supplementation in testosterone itself which generates an increased cardiac risk or if it is the behavior, in particular sexual or sporting, of the patients. men on treatment. This is because one of the effects of this hormone when prescribed is that it stimulates libido in older men. Last February, the American agency stressed that it was not launching an alert for the moment but that it was going to investigate the subject. However, she recommended that physicians carefully weigh the ratio between benefits and risks before prescribing testosterone medications.
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