Medicines Regulator to Review Cardiovascular Risks of Testosterone Treatment

The European Medicines Agency (EMA) has announced it will review all hypogonadism medications containing testosterone, given recent concerns over the drugs’ cardiovascular (CV) risk profiles.

Although Estonia’s State Agency of Medicines requested the review, several hypogonadism medications for men and women are available throughout Europe under various trade names. Both the US Food and Drug Administration (FDA) and Estonia cited research published in PLOS ONE, which discovered an association between testosterone medication and CV complications, especially in men aged over 65 years who had an increased risk of myocardial infarction (MI) while using testosterone.

The authors of another study published in the Journal of the American Medical Association found men with pre-existing heart conditions who were receiving testosterone treatment had a higher risk of further heart problems than men who were not receiving testosterone. However, that paper has since been called problematic, as it has posted data corrections twice thus far, and a coalition has called for the study to be retracted.

The EMA will issue a future recommendation on whether testosterone therapies should be maintained, varied, suspended, or withdrawn across the European Union.