EMA to Examine Testosterone Risks

Orlando, FLSince studies have come out questioning the risk of testosterone side effects, including a reported risk of heart problems linked to the use of testosterone, regulators in some countries have decided to hold their own reviews of the use of testosterone. Testosterone lawsuits have been filed in the US, alleging men suffered adverse effects of using medications that contain testosterone. Meanwhile, concerns have been raised that studies examining the risk of testosterone side effects were not reliable.

Bloomberg (4/11/14) reports that the European Medicines Agency (EMA) is conducting a review about the risks and benefits of testosterone drugs to determine whether the drugs should continue to be sold, or be suspended or withdrawn from the market. The move comes after published studies suggested that patients who use testosterone drugs could be at a higher risk of heart problems.

The US Food and Drug Administration (FDA) has also said it is reviewing the safety of testosterone. On January 31, 2014, the FDA announced that, based on two separate studies suggesting an increased risk of cardiovascular events in men who took the medications, the FDA would investigate the risk of stroke, heart attack and death in men who took the FDA-approved products. When it made the announcement, the FDA noted that it has not concluded that testosterone treatment is associated with an increased risk of heart problems and/or death.

One of the studies cited by the FDA suggested a 30 percent increased risk of heart attack, stroke and death in men who were prescribed testosterone therapy. That study was published in November 2013 in JAMA: The Journal of the American Medical Association.

Some critics have raised concerns about the reliability of the JAMA study. The Wall Street Journal (3/25/14) notes that among the concerns are the study’s design and interpretation, and critics have requested a retraction of the study. They argue that the data is incorrect, leading to results that are not reliable. According to The Wall Street Journal, however, some critics of the study have received payments from companies that make or market testosterone medications.

The study’s authors say they stand by their research. JAMA has said it has no plans to retract the study.

Testosterone medications are approved only to treat men who have low levels of testosterone that are associated with a medical condition. Lawsuits have been filed in the US, alleging men who used testosterone therapy suffered serious side effects including cardiovascular events.