Increased heart attacks in men using testosterone: the UK importantly lags far behind the US in prescribing testosterone

On 25 February 2014 Public Citizen filed a petition with the US Food and Drug Administration (FDA) to immediately require a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all drugs containing testosterone presently on the market in the United States.1 In the petition we pointed out that in a large 27 study meta-analysis, the 13 drug industry funded placebo controlled trials collectively failed to show any increase in cardiovascular events in the testosterone subjects, but the 14 non-industry funded trials collectively showed a significant 2.06-fold increased relative risk with testosterone.2 We have also asked European Medicines Agency director, Guido Rasi, to consider similar action for Europe.3

Our petition was also necessitated by a large National Institutes of Health (NIH) funded epidemiologic study published in PLOS One, based on records of 55 000 men in the United States who had been prescribed testosterone. This found that the relative risk of heart attacks after using the drug for three months was twice the risk in the year before use in all men aged 65, and it was more than twice the risk in those men under 65 with a …