Inconsistent Evidence that Testosterone Increases CV Risk

EMA committee recommends that medication labels be changed to reflect more accurate data….

Following the FDA announcement regarding cardiovascular risk for testosterone-containing medications, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) launched a review.

PRAC states that the evidence concerning the risks of serious cardiovascular side-effects with these medications is inconsistent with some studies suggesting an increased risk for cardiac problems in men using testosterone compared to men not using it. However, these studies exhibited limitations, and other research could not solidly confirm the risk. The lack of data pertaining to men over 65 is a huge limitation which needs to be recognized as does the fact that testosterone levels decrease with age.

The committee concluded that the benefits of testosterone continue to outweigh the risks but emphasize that testosterone containing medicines should be used only where lack of testosterone has been confirmed by signs and symptoms as well as complementary lab tests.

PRAC recommends that testosterone products update the medication information to state warnings against use of testosterone in men suffering from severe heart, liver or kidney problems, and also include mention of the lack of data for men over the age of 65.

In the United States, the FDA has issued a change to the labeling for testosterone replacement medications with the aim of decreasing overall use in men with “age-related” hypogonadism.

Practice Pearls:

• PRAC states there is inconsistent evidence in regards to cardiovascular risk with testosterone containing products
• PRAC recommends a labeling change to include contraindications for use in men with severe heart, liver, or kidney problems
• Labeling changes need to also address the lack of evidence for use in men over 65.

European Medicines Agency. Review of testosterone-containing medicines started. https://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2014/04/WC500165222.pdf