What do you think of new warning labels on TRT products?

July 1, 2015

“The FDA is being very cautious, which as the protector of public health, it’s got to be," says one urologist.

Dr. Strumeyer“Some of these just make sense. I don’t know all of the labeling changes, but most stuff like that makes sense. Don’t take it if it isn’t prescribed by a physician. Don’t take it unless you have low testosterone, things like that-I think that makes perfect sense.    

I think most people think that way, but I do know that testosterone clinics have opened up, which is why a lot of this is happening. All of a sudden, we have more headaches in getting approval for testosterone replacement from a lot of insurance companies.

Related: Long-term TRT study refutes concerns about prostate safety

I know where my son lives in Houston, right next to him is a testosterone clinic where men can just walk in, complain about something, and get shots. I think that’s where this is coming from, honestly. I think it’s just been overprescribed for people who don’t really need it. It is good for people who are doing that to be warned that it is not good.”

Alan Strumeyer, MD
Millburn, NJ

NEXT: "A good practice is to prescribe testosterone to men with hypogonadism who have low testosterone and symptoms."

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Dr. Sharlip“The FDA is being very cautious, which as the protector of public health, it’s got to be. A good practice is to prescribe testosterone to men with hypogonadism who have low testosterone and symptoms. As for the warning about cardiovascular disease-patients who have cardiovascular disease, low testosterone, and symptoms should be treated with testosterone because in my opinion, the risk of having low testosterone exceeds the risk of treatment, because cardiovascular risk from treating low testosterone is probably nonexistent. Two recent studies notwithstanding, the weight of evidence is that there is more cardiovascular disease if you don’t treat low testosterone than if you do.

Also see: Studies examine risk factors for low, high T

There is a gradual decline in testosterone level with increasing age, but I’m not aware of any studies that define what a normal testosterone level is in relationship to age. If any patient has low testosterone and clear symptoms of low testosterone, they should be treated. The idea of saying, ‘Don’t prescribe testosterone for conditions related to aging’ is meaningless because there are no standards for normal testosterone by age.

Clinics that prescribe testosterone indiscriminately are bad practice, but people in the testosterone treatment business to make a buck aren’t going to pay a whole lot of attention to these warnings. They will face increased risk for malpractice action when there are complications from inappropriate overtreatment with testosterone. It might put some brakes on that sort of practice.”

Ira Sharlip, MD
San Francisco

NEXT: “Testosterone replacement therapy provides so many benefits for the aging male."

 

 

Dr. Bu“Testosterone replacement therapy provides so many benefits for the aging male, such as maintaining muscle mass, maintaining bone density, and even maintaining short-term memory and higher mental function. It keeps men functioning, not only physically, but mentally and emotionally in the workplace, as our changing American economy is requiring Americans to continue working longer in their lifespan. We need to know more, and the way to get the information is not to react like the medical regulatory ostrich.

Concern about the cardiovascular risk when treating men with low testosterone emanates from poorly compliant patients and non-urologists who don’t understand the importance of good follow-up. Patients need to be watched, not only for kidney and liver function and PSA levels, but also for the red blood count.

If men are properly monitored and the red blood count increases to a level of polycythemia-increasing stroke and heart attack risks-if we have medical phlebotomy or blood donation, then men can continue TRT and can augment the supply of blood at local blood banks, and it remains a safe therapy.

Shot clinics have destroyed the public and administrative perspective of good medical treatment of low testosterone with symptoms in men with a variety of conditions. It gives a tawdry appearance, much like the shot clinics did for ED.

When practitioners treating low testosterone and ED provide best-practice policies, and practitioners follow the best-practice policy statements, that’s a softer form of regulation that is more self-regulation. Leave it to the legal system to punish those who practice outside of established standards. That would be my recommendation.

Unfortunately, most guidelines in this field have been established by internal medicine endocrinologists. They carry political clout, but they’re primarily thyroid and diabetes doctors who should know this but don’t because they don’t use it. It’s not the field they’ve lived in. Some of us were treating low T long before it became trendy. I’ve treated men with low testosterone since 1985.”

Jeffrey Buch, MD
Frisco, TX

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