Got “Low T?” Buyer Beware — the Therapy May Not Be Safe!
By Bob Aronson
Almost everyone is familiar with the commercials and ads that offer relief for men suffering from “Low T.” Most interpret that to mean “diminished sex drive” and there is no end to the number of claims of treatments and/or cures. Bottom line? They are selling sex. The manufacturers of “Low T” products, physicians, clinics and therapists are pandering to the male fear of erectile dysfunction and there’s absolutely no guarantee that any of the products will work. Worse yet, they could kill you.
The ads produced by those who are promoting Testosterone therapy amount to fear mongering at its
worst. Nothing will destroy a man’s ego faster than an inability to perform in bed and many will go to any extreme to make sure that doesn’t happen. If you could drill deeply into the male ego you likely would find that the ability to get and hold an erection is extremely important and when that ability is lost even once, many men will feel as though they have lost their manhood and that their life is over. The ads posted here are real.
The “Low T” condition should not be taken lightly, if in fact that is an accurate diagnosis. Unfortunately the number of physicians and others who offer that diagnosis is far greater than the number who are qualified to do so or who even perform a thorough examination
In 2013, 2.3 million men received a prescription for testosterone, up from 1.3 million in 2010, according to the U.S. Food and Drug Administration (FDA). About 70 percent of men prescribed testosterone drugs were between the ages of 40 and 64.
According to an FDA analysis, 21 percent of patients prescribed testosterone drugs did not appear to have had their testosterone concentrations tested before or during treatment, something the agency described as “concerning.”
On Tuesday, September 17, 2014 an FDA advisory panel said that Testosterone replacement therapies should be “Reserved for men with specific medical conditions that impair function of the testicles.” While the FDA is not obligated to follow advisory panel advice, it typically does. The panel also recommended that companies be required to conduct additional studies to assess the cardiovascular risk of their products for patients with age-related low testosterone.
Symptoms of low testosterone include loss of libido, decreased muscle mass, fatigue and depression.
The panel voted 20-1 in favor of restricting the drugs’ authorization to people with medically related low testosterone, such as a tumor or genetic disorder.
If the FDA acts on the recommendation companies could not market or promote their products for age-related low testosterone, but physicians would still have the right to prescribe products “off label” in any way they choose. An important lesson for consumers is that just because a physician prescribes it, doesn’t mean it’s right for you.
What is Testosterone?
The Mayo Clinic says this: Testosterone is a hormone produced primarily in the testicles. Testosterone helps maintain men’s:
- Bone density
- Fat distribution
- Muscle strength and mass
- Red blood cell production
- Sex drive
- Sperm production
Hypogonadism is a disease in which the body is unable to produce normal amounts of testosterone due to a problem with the testicles or with the pituitary gland that controls the testicles. Testosterone replacement therapy can improve the signs and symptoms of low testosterone in these men. Doctors may prescribe testosterone as injections, pellets, patches or gels.
What are the Risks of Testosterone Therapy?
Also according to the Mayo Clinic http://www.mayoclinic.org/healthy-living/sexual-health/in-depth/testosterone-therapy/art-20045728?pg=2
Testosterone therapy has various risks. For example, testosterone therapy may:
- Contribute to sleep apnea — a potentially serious sleep disorder in which breathing repeatedly stops and starts
- Increase your risk of a heart attack
- Cause acne or other skin reactions
- Stimulate noncancerous growth of the prostate (benign prostatic hyperplasia) and growth of existing prostate cancer
- Enlarge breasts
- Limit sperm production or cause testicle shrinkage
- Increase the risk of a blood clot forming in a deep vein (deep vein thrombosis), which could break loose, travel through your bloodstream and lodge in your lungs, blocking blood flow (pulmonary embolism)
The American Recall Center http://www.recallcenter.com is a consumer oriented group with the following vision. “At the American Recall Center, we aim to give pertinent information on FDA warnings for prescription drugs and medical devices. Through our extensive library of recalls and medical information, and our experienced editorial team, it is our mission to empower those who have been adversely affected.” In other words, they monitor the health care environment and provide accurate and timely information about drugs, procedures, devices and practices that affect individual Americans.
Recently I was contacted by The American Recall Center http://www.recallcenter.com and alerted to their concerns about Testosterone Therapy and the various actions being taken with regard to the practice. I looked carefully at what they had to say and also conducted my own brief investigation that resulted in verification of their claims. What follows is a direct copy from their website. It is alarming and should be taken very seriously by anyone either undergoing such therapy or considering it.
The treatment of low testosterone (also known as hypogonadism or Low-T) in men has increased significantly since the year 2000. However, with the growth of such testosterone replacement therapy, there has also been an increase in the number of studies that have shown a link to various medical problems, such as the increased risk of heart attacks, strokes and other potentially deadly outcomes. As a result, the FDA has issued several statements on the use of testosterone therapy, and a number of lawsuits have been filed claiming that treatments to combat low testosterone have resulted in harm to the patient or even fatalities.
FDA Investigation and Testosterone Replacement Therapy
Although the FDA has not issued any recalls of testosterone due to the possibly dangerous nature of various treatments, early in 2014 the agency published an alert stating that it was going to begin investigating the potentially adverse outcomes of testosterone supplements. Specifically, the FDA denied any conclusions related to increased probability of heart attacks, strokes or death in men undergoing testosterone replacement therapy. However, the agency said that would analyze data from multiple studies and monitor side effects of testosterone treatments as reported through its MedWatch program. The FDA also advised patients and physicians to understand both the risks and the benefits of drugs and supplements before beginning any treatment.1
In June 2014, the FDA announced that it manufacturers of testosterone would be required to add a warning label to their products indicating the possible formation of blood clots in patients’ veins. The agency stressed that this requirement was unrelated to the separate investigation into the other health problems that may be associated with testosterone use.2
Testosterone Lawsuits and Multidistrict Litigation
As a result of the potentially dangerous consequences of taking various low-testosterone treatments — which are available as topical gels, transdermal patches, buccal systems, subcutaneous pellets and injections — a significant number of lawsuits have been filed against manufacturers of testosterone products.
Because of the large number of cases related to testosterone products, and the even larger number of potential future case that could expand into the thousands, the United States Judicial Panel on Multidistrict Litigation has created MDL No. 2545 to handle actions related to testosterone products. In the original order, the panel noted its hesitancy to encompass an entire industry with a broad range of products under a single MDL. However, the panel members acknowledged that even among different products and across competing companies, many of the claims associated with the testosterone cases have common discovery, and thus are suitable for MDL status.
At the time of the original order on June 6, 2014, forty-five cases across four districts were pending. Since then, additional cases have been added.4
Testosterone Manufacturers Facing Lawsuits
The following table lists companies that have faced lawsuits related to their testosterone treatments, along with the names of some commonly known testosterone products they have developed. Other companies also may have faced litigation for their testosterone products.
|AbbVie Inc./Abbott Laboratories Inc.||AndroGel|
|Eli Lilly and Co./Lilly USA LLC||Axiron|
|Endo Pharmaceuticals||Aveed, Delatestryl, Fortesta|
|Actavis, Inc.||ANDA, LibiGel, Testosterone Enanthate Injection USP, Testosterone Cypionate Injection USP, AndroDerm|
|Auxilium Pharmaceuticals, Inc.||Testim, Testosterone Gel CIII, Testopel, Striant|
|Pfizer, Inc./Pharmacia & Upjohn Co.||Depo-Testosteroneh, Depo-Testadiol|
According to Healthline (http://www.healthline.com/health/low-testosterone/natural-boosters#1), there are some alternatives to Testosterone Therapy and while there’s no guarantee they will work, there is no guarantee the therapy will work either and these alternatives, unlike the therapy, won’t hurt you.
Additionally, following these suggestions can help your general health as well as low testosterone production. Try them, you have nothing to lose and a better life to gain.
- Get a Good Night’s Sleep
It doesn’t get more natural than a good night’s sleep. A University of Chicago study showed that lack of sleep can greatly reduce a healthy young man’s testosterone levels. That effect is clear after only one week of shortened sleep. Testosterone levels were particularly low between 2:00 and 10:00 p.m. on sleep-restricted days. Study participants also reported a decreased sense of well-being as their blood testosterone levels dropped.
How much sleep your body needs depends on many factors, but theNational Sleep Foundation suggests that adult males generally need between seven and nine hours per night.
- Lose That Excess Weight
It is not uncommon for overweight, middle-aged men with prediabetes to also have low testosterone levels. A 2012 study revealed that weight loss among men with prediabetes improved their testosterone levels by almost 50 percent.
These findings don’t mean you have to go on a crash diet. The healthiest way to achieve and maintain a healthy weight is through a sensible diet and regular exercise.
- Get Enough Zinc
Men with hypogonadism generally have zinc deficiencies. Studiessuggest that zinc plays an important part in regulating serum testosterone levels in healthy men.
According to the Office of Dietary Supplements, adult males should get 11 mg of zinc and females should get 8 mg of zinc each day. Oysters have a lot of zinc. It is also found in red meat and poultry. Other food sources include beans, nuts, crab, lobster, whole grains, and many fortified foods.
- Go Easy on the Sugar
Zinc isn’t enough to ensure you’re getting the all the nutrition you need. The human body is a complex system that requires a wide variety of vitamins and minerals for smooth operation.
Research published by The Endocrine Society shows that glucose (sugar) decreases testosterone levels in the blood by as much as 25 percent. This was true of study participants whether they had prediabetes, diabetes, or a normal tolerance for glucose.
- Get Some Good Old-Fashioned Exercise
Studies show an increase in total testosterone levels after exercising, especially after resistance training. Low testosterone levels can affect your sex drive and your mood, but the good news is that exercise improves mood and stimulates brain chemicals that help you feel happier and more confident. Exercise also boosts energy and endurance and helps you sleep better. All that can help with your sex drive and sexual performance, too. Fitness experts recommend 30 minutes of exercise every day.
Avoid Alcohol. And…a final tip and this one is mine. If you are concerned about your ability to perform sexually you should know that consuming alcohol will not help. Alcohol often will present two contradictory effects. The first effect is that it will diminish your inhibitions and therefore boost your desire for sex. Unfortunately, the increased desire is usually met with a decreased ability to get an erection. You get all dressed up with nowhere to go.
Bob Aronson of Bob’s Newheart is a 2007 heart transplant recipient, the founder of Facebook’s over 4,000 member Organ Transplant Initiative (OTI) and the author of most of these donation/transplantation blogs. You may comment in the space provided or email your thoughts to me at firstname.lastname@example.org. And – please spread the word about the immediate need for more organ donors. There is nothing you can do that is of greater importance. If you convince one person to be an organ and tissue donor you may save or positively affect over 60 lives. Some of those lives may be people you know and love.
Posted on September 19, 2014, in Health care and tagged alternatives, American Recall Center, cardiovascular risk, Erectile dysfunction, FDA, gonads, Low T, risks, sex drive, testosterone therapy, warnings. Bookmark the permalink. 1 Comment.