agreed. when I first read the news report I did not see it as a big deal
Below is extract from WSJ for those not subscribed -
http://online.wsj.com/articles/fda-...n-testosterone-drugs-for-low-t-use-1410994105
"A Food and Drug Administration panel on Wednesday recommended that makers of testosterone-replacement drugs study possible increased risks of heart attack and stroke from the hot-selling products.
The outside panel of experts also voted overwhelmingly that the FDA should come up with language in the products' labels to restrict the intended uses of the drugs, which critics say are overprescribed. The decision could have implications for millions of older men taking the medicines.
At issue are drugs that are supposed to be aimed at men with low levels of testosterone for medical reasons, like genetic causes or chemotherapy. However, the medicines are
widely prescribed for older men trying to boost their sex drives or low energy levels.
Among existing products are AndroGel from
AbbVie Inc.
ABBV +1.74% and Axiron from
Eli Lilly LLY +0.17% & Co. Companies that make the products say they don't condone their use for off-label purposes.
The FDA said early this year that it was
monitoring the risk from testosterone productsin light of recent studies suggesting serious side effects. Of particular concern to public health officials has been the loose prescribing of drugs for a condition sometimes called "low-T," in which some men are taking drugs more for lifestyle reasons rather than medical ones.
The agency said in its briefing documents for Wednesday's hearing that it has seen a 65% increase in sales of such products between 2009 and 2013. In this report, FDA staffers wrote that the agency faces the "challenge" of determining whether a given person's low testosterone levels stem from normal aging or from disease.
Earlier this year the FDA said that it was investigating the possibility that men who are taking testosterone-boosting products may face increased risk of stroke, heart attack and death. The FDA initially had begun looking at this issue in 2010 after a clinical trial of the products showed elevated numbers of cardiovascular adverse events. But more recent research triggered renewed activity on the part of the agency.
One study in November 2013, published in the Journal of the American Medical Association, found a 30% increased risk of death, heart attack and stroke among men taking testosterone, compared with other men.
The National Institutes of Health already is sponsoring a trial to investigate whether older men taking testosterone therapy primarily benefit physically or are hurt by heart disease and other side effects.
The FDA usually follows the recommendations of its advisory committees, but doesn't always do so.
The FDA had asked its outside panel of experts to address two issues: Whether current evidence still supports the use of testosterone products in certain patients, and whether there is a risk of major cardiovascular events like stroke, heart attack and death linked to testosterone therapy.
The agency briefing paper, which reviewed existing studies, concluded that "the evidence for increased risk of cardiovascular events with testosterone replacement therapy is not conclusive." The FDA report said the studies did, however, demonstrate that men getting testosterone replacement "are more likely to have underlying" medical conditions. It also concluded that additional research is needed to resolve the issue."
