WASHINGTON (AP) — 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 attack.
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. The agency
said its review was first prompted by a U.S. Veterans Affairs study
published in November 2013 that showed a 30 percent increase in stroke,
heart attack and death among older men taking testosterone.
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.
But Public Citizen says studies published as early as 2010 should have prompted FDA action.
"It
is quite clear that testosterone treatment increases the risks of
cardiovascular diseases, including heart attacks," said Dr. Sidney
Wolfe, of Public Citizen’s health group.
In his petition to the
FDA, Wolfe points to an analysis of 27 testosterone trials published
last April. The researchers found that while 13 studies funded by drug
companies did not show an increase in heart problems, 14 non-industry
funded trials showed a two-fold increase in risk in heart problems.
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.
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.
But
the latest advertising push by drugmakers is for easy-to-use gels and
patches that are aimed at a much broader population of otherwise healthy
older men with low levels of testosterone, the male hormone that begins
to decline in the body after age 40.
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.
Watson Pharmaceuticals markets the Androderm patch, which slowly
releases testosterone into the bloodstream. Fortesta is another
testosterone gel from Endo Pharmaceuticals, and Eli Lilly’s Axiron is an
underarm gel that rolls on like deodorant.
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