The European Medicines Agency (EMA), the European Union’s drug regulators, has announced it will study the benefits and risks of testosterone replacement drugs in light of studies suggesting these drugs increase heart risks for the men who use them.
The agency will issue its opinion about whether authorization to market these medications should be maintained or should be changed, suspended or withdrawn across the group of 28 nations, Bloomberg News reports.
Testosterone drugs under various brand names and formulations have been approved in several EU countries. Testosterone is sold as capsules, implants for under the skin, patches, or gels. These drugs are prescribed mainly to men who don’t produce enough testosterone, the EMA said; some women use the medications for menopause symptoms. In the EU, testosterone drugs are not permitted for healthy, older men, according to Bloomberg News.
One of the studies that prompted the EMA review, an article published in January in the journal PLoS One, suggests that testosterone increases the risk of a heart attack in all men older than 65 and in younger men with heart disease. In January, the U.S. Food and Drug Administration (FDA) said it was examining data on testosterone drugs because of potential harm to the heart, Bloomberg News writes.
The Chicago Tribune reported that clinical trials have shown that testosterone therapy produces inconsistent or no benefits for weight, depression, or lower extremity strength and modest benefits in lean body mass and body fat, libido and sexual satisfaction. In an article last year on testosterone replacement therapy, Consumer Reports magazine medical experts warned about testosterone’s risks to men and possibly to members of their households. The risks for men include breast enlargement, reduced fertility, heart attacks, strokes, and, possibly, faster-growing prostate cancer. Gel forms of testosterone, applied to underarms, can be transferred to people the man comes into contact with, exposing partners and children to serious unwanted side effects. Children can experience early puberty and women can develop male characteristics. Consumer Reports warns that pregnant or nursing women can transfer the hormone to their babies.