The growing use of testosterone has also faced growing personal injury lawsuits as the risk of cardiovascular events evidently increases with its use.
The FDA is now voicing its own concerns at the use of the therapy products with an expert panel voting for tighter restrictions on the growing use of testosterone in the pharmaceutical industry.
Injury Law News reports that the FDA is not required to implement the recommendations of the expert panel.
However, the agency has more often than not done so in the past. If these recommendations are approved by the FDA, it would mean that manufacturers of testosterone therapy products would be required to adhere to much stricter labeling requirements, tame the aggressive nature of their marketing campaigns, and subject their products to clinical studies to evaluate safety. Additionally, limiting insurance coverage for these drugs might serve as a deterrent to men who do not need them for medical reasons.
Testosterone drug safety
While researching the safety of testosterone drugs prior to this landslide vote, the panel evaluated a number of clinical studies. While some clinical studies have not shown an increased risk of cardiovascular events, others determined that these products could indeed increase the risk of permanently debilitating or fatal heart attacks and strokes.
The panelists were also reportedly alarmed to discover that testosterone therapy drugs have been prescribed in an inappropriate manner on an alarming scale. In fact, one estimate suggests that one-fifth to a quarter of all men who have used testosterone therapy products never actually had their testosterone levels tested.
It is presumed that these men were prescribed the drugs on the basis of their self-reported symptoms, which generally include reduced libido, fatigue, and loss of muscle mass – all of which can be attributed to the natural aging process or to other underlying problems.The panelists also discovered that only a small percentage of patients who took the drugs did so under the supervision of a specialist, such as a urologist or endocrinologist. A full 60 percent of prescriptions for testosterone replacement products were written by primary care physicians, who may not necessarily have extensive knowledge of this specific area of medicine.