An expert panel has voted overwhelmingly for the Food and Drug Administration (FDA) to impose new, stricter limitations on the testosterone drug industry. Out of 20 panelists, only one member voted against the changes.
The panel recommends tightening up labels for medicines so that they are no longer prescribed to men who have problems related to aging such as low libido.
Testosterone drugs are used by more than two million men, some of whom only use the drugs for symptoms related to aging rather than actual medical conditions that cause low T. If the FDA adopts these new regulations it could reduce the number of prescriptions being given out for testosterone therapy as well as how these drugs are marketed.
Since the early 2000s, testosterone usage has quadrupled and it is estimated that one in 25 men in their 60s is taking testosterone. In light of studies suggesting that testosterone therapy could increase the risk of stroke, heart attack and death, the FDA decided to reassess the safety of these products.
Part of the panelists decision came from some surprising information they received, such as the fact that only one fifth of men who were prescribed testosterone had actually had a baseline test to assess their testosterone level. Additionally, about 60 percent of the prescriptions were written by primary care doctors while only 20 percent were written by specialists like urologists and endocrinologists.
The FDA is taking these findings seriously, they recently rejected a new oral testosterone-replacement drug due to the fact that benefit-risk profile wasn’t sufficient enough to approve it.
Future label changes as well as how testosterone is marketed and approved could soon be on the way.
Have you or someone you love experienced serious side effects after undergoing testosterone therapy? The lawyers at O’Connor, Acciani & Levy can help you determine what your legal rights are and if you may be entitled to file a claim.