Testosterone therapy in the new era of FDA oversight

[Nelson Vergel]

In 2015, the FDA found a “weak signal” in the literature supporting an increased CV risk associated with testosterone therapy (TTh). While the medical community continues to debate this relationship, recent FDA recommendations serve to better inform men of potential health risks associated with TTh. The FDA’s decision was made in the face of rising numbers of testosterone prescriptions and in the absence of high quality data demonstrating safety and efficacy of TTh in the treatment of hypogonadism, particularly in older men. The repercussions of the FDA’s decision remain to be truly felt, and future work will determine if the FDA’s decision results in optimal patient treatment. High quality randomized controlled trials and decisive meta-analyses are needed to determine if the purported CV risk associated with testosterone is truly present. Until that day, clinicians must be selective in their prescribing of TTh in this new era of FDA oversight.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4837303/

 

[PAUL-E]

nelson I believe that risk is only caused by uneducated providers providing substandard and improper care(not managing hematocrit) what are your thoughts