New Testosterone Warnings to be Added

additional testosterone warningsWe’ve told you a lot over the past few months about the medical concerns linked to testosterone or “Low T” drugs. The FDA has now woken up from its slumber on this and is now requiring the manufactures of AndroGel and other testosterone replacement drugs manufacturers to add new warnings about the link between the medications and potential blood clots, including DVT (deep vein thrombosis), pulmonary embolism, or VTE (venous thromboembolism).  If you have been following for this at all, this comes as no surprise.  This was predictable as a new crisis in Kim Kardashian’s life.  


What does it mean?  Well, it will make settling these cases a lot easier. Why?  Now we have a new warning.  I’ll bet these cases eventually get divided for settlement purposes in cases where the injury was before the warning and cases where the injury was after the warning.

But why are the settlements going to be easier now?   Okay, sorry.  That was the question.  Settlements will be easier because they don’t need to defend the old warning anymore from a marketing standpoint.  It is really tough to settle cases with the old warning because then you are just inviting new lawsuits for every new injury (or death, of course) case. Now, they can wipe the slate clean when these cases eventually do settle.


Testosterone is a hormone that is produced primarily in the testicles and is essential to the development of male growth and masculine characteristics. Production peaks during adolescence and early adulthood and then drop slightly each year after that. Testosterone plays a key role in the creation of muscle mass and strong bones. While approved for those men diagnosed with hypogonadism, low testosterone levels, many have sought a prescription for a little extra boost and increased sex drive….but, is it worth it?  The answer is probably yes for most of us if there is no possibility of downside risk.  If there was no trade-off, there really would be no reason not to give this stuff a try and see if it makes you look/feel/act a little bit younger.  There are like 5% of us over 40 who are not shooting for this.  But, if there is real risk, the vanity exercise is not working for most of us.   So all these companies had to do was give us a real choice.   Why didn’t they?  Well, we can’t speak for one of them much less all of them.  But let’s be creative here for a second.  What would happen to sales if everyone knew of the risks of this therapy?  That whole trite “follow the money” thing always annoys me. But, you know, follow the money. Because it is the most likely reason why this information was not provided to us a lot earlier. 


The new label warning changes the existing blood clot warning from one linking the problem to polycythemia to a more generalized venous thromboembolism warning.  VTE are blood clots that occur in the veins, which can lead to painful clots in the legs, clots known as deep vein thrombosis.  The VTE can also break off and flow to the heart and lungs causing a potential pulmonary embolism, which is often fatal.  The new warning notes that these blood clots appear to be a different problem than those causing the testosterone users to suffer heart attacks and strokes.


The newest FDA concerns come just after it was announced earlier this month that all testosterone drug lawsuits filed in federal courts would be consolidated into a multidistrict litigation (MDL), for the purposes of pretrial proceedings.   The new warning and this development are likely to be the keys to getting these cases resolved when we look back on this litigation years from now. The low T drug lawsuits are primarily filed against makers of AndroGel, but also involve claims against Axiron, Testim, Foresta, AndroDerm, and Depo-Testosterone. No doubt that while all current suits involve common allegations that the medications caused plaintiffs to suffer heart attacks, strokes, blood clots, and other cardiovascular injuries, future suits will certainly include those with claims of venous thromboembolism.  


If you or a loved one has been hurt or killed from testosterone therapy treatment, contact us for more information and to find out your rights.  You may be entitled to monetary compensation.  Contact us today at 800.553.8082 or online here.

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