In recent months at least two respected medical research studies have raised red flags over concerns that Low-T therapy medications being used by millions of men may put these men at serious risk of suffering a stroke or heart attack.
In the wake of the reports the Food and Drug Administration issued a national Drug Safety Communication in which officials said they are “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.”
Well, just an investigation is not good enough, according to the national, non-profit organization Public Citizen, which has petitioned the FDA to include a black-box warning on the medications alerting patients to these dangers.
Public Citizen believes the manufacturers of such FDA-approved Low-T treatments such as AndroGel, Androderm, Axirom, Bio-T-Gel, Delatestry, Depo-Testosterone, Fortesta, Striant, Testim and Testopel have not sufficiently warned men of these possible side effects. Read more on Low-T lawsuits forming.
Black-box warnings are the FDA’s strongest and Public Citizen is arguing the warnings are not sufficient and that many men who don’t even actually have ca clinical diagnosis of low testosterone are using these medications and putting their lives in peril.
“We urge the FDA to ask manufacturers to send “Dear Doctor” letters to warn physicians of these serious adverse effects and to require that the FDA-approved Medication Guide for testosterone products, dispensed to patients when their prescriptions are filled, be updated to include this new warning,” Public Citizen wrote in its petition.
“The urgency for this action is highlighted by the massive prescribing of testosterone-containing products, with more than 400,000 prescriptions filled in the U.S. in December 2013 alone and more than 5 million filled during all of 2013.
“Despite increasing evidence of significant cardiovascular risk from an analysis of 27 randomized clinical trials and, most recently, from a large observational study involving 45 times more testosterone-exposed men than the largest previous study, warnings of testosterone-induced cardiovascular risk are dangerously absent from the current FDA-approved labeling for all of these products. In the face of this accumulating evidence, the FDA was reckless, from a public health perspective, to state three weeks ago that it “has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death.”