By Toni Clarke
Feb 25 Drugs used to treat low testosterone
should carry strong warnings about the risk of heart attacks and
other cardiovascular problems, the consumer advocacy group
Public Citizen said on Tuesday.
The group has petitioned the U.S. Food and Drug
Administration to add a "black box" warning, the most serious
possible, to the product labels of the drugs.
The group said its petition was based on growing evidence of
the drugs' risks of heart attacks and other cardiac dangers from
studies dating back to 2010 and a recently published analysis of
27 studies going back as far as 20 years.
Of the 27 studies, 14 that were not funded by the
pharmaceutical industry showed a "highly significant" increased
risk, Public Citizen said. Thirteen were funded by drug
companies and those studies showed no increased cardiovascular
Last month, the FDA issued an alert and said it was
investigating the risk of stroke, heart attack and death in men
taking testosterone drugs based on the recent publication of two
studies that suggested increased cardiac risk.
But the FDA said it had not concluded that testosterone
does, in fact, increase heart problems.
Dr. Sidney Wolfe, senior adviser at Public Citizen's health
group, said the FDA's statement was "reckless" and "a betrayal
of the FDA's role as an agency in the U.S. Public Health
"It is quite clear that testosterone treatment increases the
risks of cardiovascular diseases, including heart attacks," he
The FDA said it is reviewing the petition and will respond
to Public Citizen. FDA spokeswoman Andrea Fischer said that
during a prior review of cardiovascular risks associated with
testosterone therapies the agency found that the data was "mixed
and insufficient to support a regulatory action."
"In reaching this decision, FDA took into account the
consistency of the findings across studies, as well as the
quality of the existing data sources," she said. "FDA is unable
to reach conclusions based on the current data until we have had
the opportunity to review the strengths and weaknesses of the
new studies and integrate the findings with all other available
and appropriate data."
Testosterone therapy is approved by the FDA for men who lack
or have low testosterone in conjunction with an associated
medical condition, such as a genetic failure of the testicles to
produce testosterone. Symptoms can include loss of libido,
depression, decreased muscle mass and fatigue.
According to Public Citizen, almost 25 percent of men
prescribed testosterone did not previously have a blood test to
determine if their level was low.
The FDA's alert followed publication of a study in the
journal PLOS ONE showing that men over the age of 65 had a
two-fold increase in the risk of heart attack within 90 days of
filling an initial prescription.
Among men under the age of 65 with a history of heart
disease, there was a two-to-three-fold increased risk of heart
attack, although there was no increased risk in younger men
without a history of heart disease.
In older men, the increased risk was seen regardless of
whether they had previous heart disease history.
The market for testosterone treatments currently includes
skin patches, short-acting injections and topical gels. AbbVie
Inc's AndroGel, the market leader, generated about $1.2
billion in sales in 2012.
"At the current rate of prescribing, almost 13,000
prescriptions a day are filled for testosterone products in this
country," Wolfe said. "Each day of delay of the black box
warning ensures much more exposure, too often for men who cannot
benefit from the drug but will only be exposed to its risks."
The petition also urged the FDA to delay deciding on whether
to approve a long-acting testosterone product made by Endo
Health Solutions Inc called Aveed.
Aveed has twice been rejected by the FDA based on concerns
about injection-site reactions and the risk it could cause
blockages in blood vessels in the lungs.