A large new study found that prescription
testosterone raised the risk of heart attacks in older men and in
middle-aged men with a history of heart disease, prompting some experts
on Wednesday to call for more extensive warning labels on the drugs.
The new study is one of several in recent
years that have highlighted cardiac problems as a potential side effect
of testosterone gels, patches, pellets and injections. The hormone is
approved for low testosterone levels and is widely marketed for symptoms
of “low T,” including fatigue, low libido and loss of energy. Sales in
the last decade have soared.
By itself, the new study, which was not a
randomized trial, the gold standard in medical research, “may not tell
us very much,” said Dr. Michael Lauer, the director of cardiovascular
sciences at the National Heart, Lung and Blood Institute,
who was not involved in the study. “But when you put this together with
the rest of the medical literature, this tells us that we potentially
have a problem.”
The drugs carry no mention of an increased
risk on their labels or in their advertising materials, said Dr. Sidney
M. Wolfe, a senior adviser to the Washington advocacy group Public Citizen.
“Given that there have been several studies now, I don’t see how the
Food and Drug Administration can justify having no warnings of heart
attacks at all,” he said.
In a statement, Andrea Fischer, an F.D.A.
spokeswoman, said the agency was reviewing the new findings. “We will
communicate any new safety information on testosterone products when our
reviews of all new information have been completed,” she said.
The new study,
published on Wednesday in the journal PLoS ONE and funded by the
National Institutes of Health, tracked about 56,000 older and
middle-aged men around the country who were prescribed testosterone
between 2008 and 2010. The study looked specifically at their rate of
heart attacks in the year before receiving their new prescriptions, and
in the three months after.
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