FDA clamps down on testosterone labeling rules
- The FDA is requiring that drug makers change labeling to inform users of increased risk of heart attack and stroke from testosterone products.
- The agency has issued an advisory that testosterone replacement is only approved for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause hypogonadism.
- In a release, the FDA recommended that health care professionals should only prescribe testosterone for men with the approved conditions.
After years of free-for-all marketing in which testosterone therapy has been held up as a cure-all for "aging," the FDA has come down hard after a long period of attempting to rein in this therapeutic area. First, there is the reiteration of the approved uses of testosterone therapy and then there is the warning of the increased risk of cardiovascular events.
According to Drug Watch, testosterone therapy generated $2 billion in revenues in 2012, with $4 billion anticipated by 2017. New FDA guidance may slow that growth rate down as both consumers and physicians reconsider how they prescribe and use testosterone replacement therapy.