07/21/2025
ABOUT THAT ‘Dangerous’ TESTOSTERONE…….
For years, patients have been unduly apprehensive about testosterone replacement therapy due to the black box warning, (despite numerous studies showing otherwise and numerous more showing adverse affects of low testosterone) leading many to avoid a treatment that could significantly improve their health,” life, marriage etc.
Among the labeling changes, the FDA recommended removing language from the black box warning of all testosterone products that stated testosterone therapy could lead to increased risk for adverse cardiovascular outcomes.
As I’ve reported in the past, findings from the TRAVERSE trial revealed the percentage of men with hypogonadism who received transdermal 1.62% testosterone gel (AbbVie) had a similar risk for a major adverse CV event as those receiving placebo.
The FDA cited the TRAVERSE trial in its labeling change and recommended adding the TRAVERSE results to testosterone products. The agency also recommended retaining limitation of use language for age-related hypogonadism.
The FDA is also requiring the addition of a new warning for testosterone products regarding a risk for increased blood pressure. According to the agency’s announcement, the decision was made based on the findings of postmarket ambulatory BP studies. In March 2018, the FDA issued a requirement that postmarket ambulatory BP studies should be conducted for all testosterone products. According to the agency’s release, results from completed studies found testosterone products class-wide are tied to increased BP.
Product-specific information on increased BP must be added to testosterone labels if the product has completed its postmarket ambulatory BP study, according to the FDA.
**Now: If only RFK can get them to leave vitamin D, K, peptides, SARMs, and HCG alone and ditch Prior Authorizations and Pharmacy Benefit Managers (PBMs). Oh, and LEGALIZE IBOGAINE!!!