A consumer advocacy group is urging the Food and Drug Administration (FDA) to add a warning label to popular testosterone drugs for men due to mounting evidence that the drugs can boost the risk of heart attack.
The group Public Citizen is calling for the agency to immediately put a "black box" warning, the most serious kind, on all testosterone medications and to make manufacturers warn physicians about a higher risk of heart attack, stroke and death as a result of the treatments.
According to Public Citizen, studies dating as far back as 2010 have indicated risks of cardiac problems linked to testosterone drugs. A recently published analysis of 27 studies stretching as far back as 20 years also contributed to their conclusion.
Of the 27 studies, 14 that did not receive funds from the pharmaceutical industry demonstrated a "highly significant" increased risk. Thirteen were funded by drug companies and demonstrated no increased cardiovascular risk.
The FDA issued an alert in January claiming it was investigating the risk of stroke, heart attack and death in men taking testosterone drugs but the FDA had not come to a conclusion that testosterone increases heart problems.
Public Citizen claims that studies published as early as 2010 should have led the FDA to take action.
"It is quite clear that testosterone treatment increases the risk of cardiovascular diseases, including heart attacks," said Dr. Sidney Wolfe, senior advisor at Public Citizen's health group.
Prior to the FDA's alert, a study in the journal PLOS ONE demonstrated that men over the age of 65 had a doubled increase of heart attack risk within 90 days of filling a first prescription. Men under the age of 65 with a history of heart disease showed a two-to-three-fold increase in risk of heart attack, though younger men without a history of heart disease showed no increased risk.
Testosterone treatments currently include short-acting injections, skin patches and topical gels.
"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 the 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 FDA has approved testosterone therapy for men who lack or have low testosterone in relation to an associated medical condition like genetic failure of the testicles to produce testosterone. Symptoms of low testosterone can include depression, loss of libido, fatigue and decreased muscle mass. Public Citizen claims that almost 25 percent of men prescribed testosterone didn't receive a blood test to see if their level was low.
Public Citizen's petition also asked the FDA to put off a decision on approval of a long-acting testosterone product called Aveed, made by Endo Health Solutions Inc. The FDA has rejected Aveed two times based on concerns over injection-site reactions and the possibility of it causing blockages in blood vessels in the lungs.
