There has been a rising tide of concern about the health risks tied to the use of testosterone-enhancing drugs, which have become popular among baby-boomer men trying to hold onto their middle-aged vitality and sexual performance. The FDA says it has been monitoring the stroke and heart risks but in light of two recent studies has "decided to reassess this safety issue."
No decisions have been reached, it said Friday, so men don't have to give up their treatments. But the agency said that while the drugs are approved for treating medical conditions like failure of the testicles to produce testosterone because of genetic issues or as a side effect of chemotherapy, none of them are approved simply because a man has low testosterone levels.
And that is where the growth in these drugs has come from in recent years. Products such as Eli Lilly's ($LLY) Axiron; AbbVie's ($ABBV) AndroGel; and Auxilium ($AUXL) and GlaxoSmithKline's ($GSK) Testim have rocketed as drugmakers amped up their advertising for treating what The New York Times says is being called "Low T." IMS Health says by 2017, the entire testosterone market is expected to hit $5 billion, having grown by 90% over 5 years through 2011, when it hit $1.9 billion.
But about those risks. In November, a study published in the Journal of the American Medical Association found that using testosterone increased the risk of death from heart attack or stroke by 29% in men with or without a history of heart disease. The FDA today said another study has found an increased risk of death among both younger and older men with preexisting heart disease. "We are providing this alert while we continue to evaluate the information from these studies and other available data, and will communicate our final conclusions and recommendations when the evaluation is complete," the agency said.