Low testosterone can dim a man’s sex drive, energy, and motivation. Medication to cure low testosterone can have harmful effects.
When needed, testosterone replacement therapy (TRT) can boost T levels back to normal and return a man to full vigar.
Still, there are also risks to TRT, and the long-term safety isn’t clear. A consumer advocacy group is calling on the Food and Drug Administration to add a bold warning label to popular testosterone drugs for men in light of growing evidence that the hormone treatments can increase the risk of heart attacks.
The group Public Citizen says the agency should immediately add a “black box” warning — the most serious type — to all testosterone medications and require manufacturers to warn physicians about a higher risk of heart attack, stroke and death with the treatments. The FDA announced last month that it was reviewing the safety of drugs like the blockbuster testosterone gel, AndroGel, in light of two recent studies that showed higher rates of cardiovascular problems in men.
Treating low T can strengthen a man’s bones and help prevent osteoporosis. Some evidence also suggests that treatment can also aid blood sugar control, which is important for the prevention and control of diabetes.
Lower testosterone levels have been linked to higher risk of cardiovascular problems. Again, it’s not clear if low testosterone levels actually cause heart problems, testosterone therapy can dramatically affect a man’s quality of life. Besides its sexual benefits, TRT can improve a man’s mood and energy level while reducing irritability and anger.
Testosterone therapy can raise a man’s red blood cell count. This can lead to a thickening of the blood, which may make stroke and clotting more likely.
Finally, there’s the question of prostate cancer risk. Research over the past few decades has shown little evidence of a link between testosterone replacement therapy and prostate cancer. However, the question has not been entirely laid to rest.
In January, a federally funded study of 45,000 men suggested testosterone therapy could double the risk of heart attacks in men 65 and older.
In addition to the boxed warning, Public Citizen wants the agency to delay an approval decision on an experimental, long-acting testosterone injection called Aveed. The agency is scheduled to make a decision on the Endo Pharmaceuticals drug by Feb. 28 2014. Public Citizen’s petition comes amid a marketing blitz for testosterone gels, patches and injections targeting men who report fatigue, low sex drive or other symptoms commonly associated with aging.
U.S. prescriptions for testosterone therapies have increased more than five-fold in recent years, with sales over $1.6 billion.
FDA labeling on the drugs indicates they are only to be used for men who have abnormally low testosterone caused by a medical condition. Drugmakers and many doctors claim testosterone therapy can reverse some unpleasant side effects of aging — ranging from insomnia to erectile dysfunction. Those claims are mostly based on short-term studies. The top-selling product in the field is Abbvie’s Androgel, which is applied to the shoulders and arms.