[IMG] 12:10 pm ET Nov 21, 2014 Testosterone Drugs may – or may...

12:10 pm ET
Nov 21, 2014
Testosterone Drugs may – or may not – Cause Heart Risk: EMA
http://blogs.wsj.com/pharmalot/2014/11/21/testosterone-drugs-may-or-may-not-cause-heart-risk-ema/

The European Medicine Agency has decided that there is no “consistent evidence” that testosterone treatments pose an increased risk of heart problems. But the agency does want product labeling updated to indicate that physicians should confirm a lack of testosterone and run lab tests before proceeding with treatment.
In reaching its conclusion, an EMA committee reviewed studies suggesting an increased risk in heart attacks as well as safety data collected since the drugs have been marketed, but that the picture appears mixed. Some studies suggested an increased risk, but some did not. Still other studies had problems with design that limited conclusions that could be drawn, according to an EMA statement.
The decision comes amid ongoing controversy over the cardiovascular safety and allegations of inappropriate marketing of these widely prescribed drugs, which have attracted sustained regulatory scrutiny. Earlier this year, for instance, Health Canada asked drug makers to update product labeling after deciding evidence from published studies and case reports did suggest a risk for heart problems.
Two months ago, an FDA panel recommended drug makers study the risk of heart attacks and suggested prescribing information should include language that the drugs have not been proven to reverse common effects of aging, such as low libido, fatigue and muscle loss. The FDA, which already rejected a citizen’s petition to add serious warnings, must still decide whether to follow the recommendations.
As we noted previously, over the last several years, the marketing for various testosterone treatments has warned that low testosterone can interfere with sex drive, moods and energy levels. In the U.S., for instance, marketing helped to nearly double usage between 2010 and 2013. About 2.3 million men now use the drugs. We asked the EMA for comparable usage data and will update you with any reply.
However, FDA reviewers recently noted that about 21% of men who take these drugs did not have lab work to indicate treatment was needed, a step that the EMA is now addressing. Meanwhile, though, the increased usage over the past few years has been accompanied by a growing number of studies suggested the medicines may cause cardiovascular problems, such as heart attacks.
A study published last year in the Journal of the American Medical Association of nearly 9,000 veterans being evaluated for coronary artery disease found that those who used testosterone had a 29% higher risk of heart attack and stroke than those who did not.
Another study published earlier this year in PLOS One found the risk doubled during the first three months after starting therapy among men younger than 65 years old who had a history of heart disease. The risk also doubled for all men older than 65 – those with or without heart disease – shortly after beginning treatment.
But as the EMA noted, not all studies have suggested a risk. Last July, a study of 24,000 Medicare patients found that testosterone therapy did not increase the risk of heart attack and even lowered the risk by about 30% in the group of men judged most likely have one based on other factors. The study was published in the Annals of Pharmacology.