FDA Says Men Who Receive Drugs for "Low-T" Have 30% Increased Risk of Major Adverse Cardiovascular Events

As I reported back in February this year, Public Citizen urged the FDA to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S. (see "Public Citizen Petitions FDA to Add a Black Box Warning to Low-T Drug Labeling").

That petition may have lead to the FDA calling for an advisory panel meeting on Sept. 17 to discuss "two controversial issues regarding testosterone replacement therapy (TRT) that have important public health implications. The first issue is identification of the appropriate patient population for whom TRT should be indicated, and the second is the potential risk of major adverse cardiovascular events (or MACE, defined as non-fatal stroke, non-fatal myocardial infarction, and cardiovascular death) associated with TRT use" (see FDA's briefing document here).

More worrisome is the fact that only about one-half of men taking testosterone therapy had been diagnosed with hypogonadism, and 25% did not have evidence of having their testosterone concentrations tested prior to initiating therapy.

And more and more men are receiving prescriptions for so-called "Low-T" drugs such as Androgel. How many more?

In 2010, 1.3 million patients received a prescription for testosterone and by 2013, this number has risen to 2.3 million patients. "Direct-to-consumer advertisement emphasizing the benefits of TRT related to quality-of-life, such as vitality and strength, and non-branded disease awareness campaigns of 'low T' have targeted a broad population of men," said FDA.

FDA said it “has decided to reassess the appropriate patient population for testosterone replacement therapy and to ensure that the labeling for FDA-approved testosterone therapies appropriately reflects the population for whom therapy is indicated.”

The advisory panel is charged to advise FDA whether it should revise the current indication for testosterone therapies and if the agency should require sponsors of testosterone products to conduct a postmarketing study (e.g. observational study, controlled clinical trial) to further assess a potential cardiovascular risk with the use of TRT.