EMA ruling on testosterone

The stroke debate is over, so says a regularity panel appointed by the European Union. They found that there is no consistent evidence to suggest that testosterone use in men causes increased risk of serious cardiovascular episodes: like strokes and heart attacks. They even found that in some cases, cardiovascular problems were caused by not treating low testosterone levels with testosterone therapy when they should have been.

This finding refers to men being treated to clinically diagnosed hypogonadism, not just older men who think they need to feel younger. The ruling means that anyone who suffers from hypogonadism of any type should not worry about the hype surrounding anti-testosterone campaigners. This means anyone who suffers from clinically low testosterone levels can take testosterone therapy if they have a doctor’s confirmation of hypogonadism. Hypogonadism needs to be confirmed by physical feature assessment along with physiological and biochemical testing before the doctor can recommend testosterone therapy.

The European Medicines Agency appointed a Pharmacovigilance Risk Assessment Committee (PRAC) to analyze previous data studies and risks associated with testosterone therapy use in men with confirmed low testosterone. The investigation centered around the risk to cardiovascular health, in particular possibility of having heart attacks and strokes as a direct result of taking testosterone therapy. It looked at many published studies on testosterone therapy risks. The reason for doing this was to clear up the confusion surround the cardiovascular risks of testosterone therapy. With so many conflicting studies out there it was important for Europe to come to a final conclusion so they can label products correctly and ensure the safety of Europeans.

The findings of the PRAC assessment committee have now been endorsed by the CMDh and the decision is considered final, for now at least. The CMDh is also known as the Coordination Group for Mutual Recognition and Decentralized Procedures in humans. It is responsible for the marketing authorization of medical products in the EU.

The PRAC and CMDh confirm that product labeling will be revised to reflect these recent conclusions. The new labels will ensure that patients understand that they should undergo lab and blood testing before starting treatment, as well as having their symptoms confirmed by a doctor. Patients should be monitored closely during treatment. Testosterone levels together with hemoglobin, hematocrit, liver function, and blood lipid profiles should be tracked. The PRAC also called for further studies to be conducted on an ongoing basis so we can gather more data on the long term effects of testosterone therapy.

Alongside this warning all labeling will also include a warning about patients with existing hypertension and heart problems (including stroke and heart attacks) using testosterone therapy as, in some cases, it can cause increased blood pressure in people with existing conditions.

These finding and newly instructed warning labels echo the conclusions of the FDA in the USA who are also updating their labels. The FDA concluded that testosterone therapy should not be used in aging men who have not been medically confirmed with hypogonadism. If you have medically confirmed low testosterone levels then it is OK. US labels will also include information on the risks to cardiovascular health for those with pre-existing heart conditions or high blood pressure. In the USA more than 230 court cases have been filed against AndroGel, a popular testosterone treatment, because of their lack of cardiovascular warnings. These labeling and marketing should clear up the confusion surrounding the risks of testosterone therapy and will help avoid future cases.