News Feature | March 7, 2014

Advocacy Group Lobbies FDA For Testosterone Warning Label

Source: Pharmaceutical Online

By Marcus Johnson

The consumer advocacy group Public Citizen is lobbying the FDA to add a “black box” warning to all testosterone products. In addition to the warning label, the group wants the FDA to compel manufacturers to tell doctors about the negative side effects of testosterone products, including greater risks for stroke, heart attack, and death. Public Citizen believes that the FDA should have taken action earlier than this year. “It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks,” said Dr. Sidney Wolfe, who works for the advocacy group.

In the past month, the FDA has stated that it will be reviewing testosterone products such as AndroGel. The agency was prompted to review the products because of several studies that have found there is a correlation between testosterone products and serious cardiovascular problems. Earlier this year, a study that was funded with government dollars found that testosterone therapy treatments could double the risk of significant cardiovascular events, such as heart attacks, in men aged 65 or older. The study contained 45,000 patients.

The FDA’s review of testosterone products comes as product use has spiked in recent years. Recent sales for testosterone therapy products are over $1.6 billion. FDA labels on the products state that they should only be used by individuals with a health condition that causes low testosterone. However, industry experts believe that otherwise healthy men with symptoms of aging are being coaxed into buying testosterone therapy products. Many doctors question the long term health effects of testosterone products.

Watson Pharmaceuticals, Endo Pharmaceuticals, and Eli Lilly all have testosterone therapy products on the market.