News Feature | February 4, 2014

FDA Reassessing Testosterone Product Safety

Source: Bioprocess Online

By Marcus Johnson

Products marketed at middle aged western men looking to increase their energy levels, strength, and libidos have surged in recent years. Many of these products include testosterone therapy. Since 2010, there have been multiple studies on testosterone treatment, and there have been enough negative effects to prompt the FDA to start the reassessment process on drugs that use testosterone.

Some of the negative effects of testosterone treatments in studies have been alarming, such as a Boston study which found that, while men taking the hormone were stronger, they were also up to five times as likely to suffer from serious cardiovascular problems such as heart attacks. Another recent study found that men over the age of 65 taking the hormone were at a higher risk of cardiovascular events.

Some doctors feel that there can be benefits to testosterone treatments. However, drugs including the hormone should be prescribed to patients with truly low testosterone, but drug companies are marketing their testosterone products to a much larger segment of the population. “For people with truly low testosterone levels, the benefits outweigh the risks,” said Dr. Brad Anawalt of the University of Washington. “But for millions of others, it’s in the same category as snake oil.”

Anawalt also said that more doctors are prescribing testosterone treatments to men who actually don’t have low levels of testosterone.  The use of testosterone treatments has skyrocketed—by the end of 2011, nearly one in twenty-five men was using a drug with the hormone. “There are what I would label testosterone factories out there, and it’s terrifying because we don’t know what the long-term safety profile is,” Dr. Anawalt said.

Sources:

http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm

http://well.blogs.nytimes.com/2014/02/03/weighing-testosterone-benefits-and-risks/?_php=true&_type=blogs&_r=0