Makers of testosterone replacement drugs should collect data on heart attacks and strokes in men who use their products, and the labels on the treatments should have stronger language to restrict intended uses to reduce over-prescribing, a Food and Drug Administration (FDA) advisory panel recommended.
The FDA asked an outside panel of experts to address whether there is a risk of major cardiovascular events such as stroke, heart attack and death in men who used testosterone replacement therapies. The agency also asked the panel whether current evidence still supports the use of the drugs in certain patients.
The FDA is not required to follow the recommendations of its advisory panels, but it generally does.
Testosterone replacement drugs, such as AndroGel, Axiron and Testim, are used to boost low testosterone levels in men who report symptoms such as low libido, muscle loss, weight gain and fatigue. The drugs are intended for men who have low levels of testosterone for medical reasons, such as genetic causes or chemotherapy.
However, drug companies have heavily marketed the drugs, encouraging men to ask their doctors if they may suffer from “Low T” and could be candidates for the treatment. Panel members raised concerns that the drugs are overprescribed and are being used by men for lifestyle reasons rather than medical ones.
The FDA said in last week’s briefing that it has seen a 65 percent increase in sales of testosterone products between 2009 and 2013, and that the agency faces challenges determining whether a person’s low testosterone levels are caused by normal aging or from disease.
At issue are serious cardiovascular side effects that have surfaced from studies on the medication that show testosterone supplements can put men at an increased risk of heart attacks, strokes and death.
The agency conducted a review on the products, which resulted in a new warning for blood clots. The agency said it found the data on cardiovascular risk inconclusive and asked the panel to offer its recommendations.