Testosterone

To combat low levels of testosterone, many men recently have turned toward testosterone therapy or Low T drugs. While these are not new to the market, the method of administering them is. Instead of requiring an injection, they can be applied via a topical gel or a patch. Ease of use has caused the drugs to become much more popular in recent years.

There are some younger men who use testosterone boosting drugs; they are often involved with bodybuilding or some other athletic program. However, the majority of those who participate in Low T treatment are past middle age, and starting to enter their golden years. These men are not feeling as youthful as they once did, and after a discussion with their doctor they decide to start taking a testosterone supplement to restore their vitality.

The problem is two-fold. First taking the testosterone therapy drugs increases the patient’s risk of developing heart disease, blood clots, stroke, or even death from complications of these side effects. The second problem is that these risks are increased even more as the patient ages. Since the majority of those taking testosterone therapy drugs are already over the age of 50, the risks are exacerbated.

Hypogonadism occurs when the body does not produce enough testosterone.  The result is that the male experiences a low sex drive, sees weight gain (especially around the midsection), hair loss, and becomes easily fatigued.  There are some men who truly do experience hypogonadism; however, decreased levels of testosterone, and the accompanying symptoms, are a natural product of getting older.

The biggest misconception with testosterone levels is that they should remain constant over a male’s lifetime. This is simply not true. A young man in his 20’s will obviously have more testosterone than a man in his 80’s.

Levels are determined by measuring nanograms of testosterone per deciliter of blood. A study in the April 1999 Journal of Behavioral Medicine that looked at a wide variety of men, with varying ages, found these levels ranged from 53 to 1,500 ng/dl with the average being 679. What this study shows is that if you are below 679 then you have low testosterone; if you are above, then you have high levels. But it does not account for age of the individual. Another study described in Men’s Hormonal Health shows that young men (in their late 20’s and early 30’s) have an average level of 617 ng/dl while older men (ages 85-100) average a little more than half that amount, 376 ng/dl. The point being: as you age, levels naturally drop.

Since the levels of testosterone naturally decline through age, it is normal to feel some of these symptoms gradually coming in. An individual is truly suffering from low levels of testosterone when some of these hit suddenly. Some of the most common symptoms include:

• Low sex drive
• Fewer erections (although erectile dysfunction can result from other causes)
• Loss of muscle mass or strength
• Weight gain, especially around the mid section
• Anemia and fatigue
• Depression
• Loss of body hair

Columbia Laboratories was founded in 1986 and has its headquarters in Boston, Massachusetts. The lab is different from many of the other pharmaceutical companies in that they generally make the drugs, yet they market them through other pharmaceutical companies. This causes the tracking of Striant to be a little convoluted, and makes it difficult to determine how big of a player Striant is in the market.

Despite outsourcing the sales portion of the business, they still do well. Although not nearly as big as some of the other frontrunners in the testosterone supplement market, Columbia managed to earn $25.8 million in 2012.

In 2011, Striant was sold to the company Actient. It is currently distributed through the pharmaceutical company Auxilium, the same company that manufactures Testim.

Striant found FDA approval in 2002. While many of the low T therapies around are applied in gel form to the underarm or shoulders area, Striant takes a different approach. The patient will hold a packet between the gum and the inner cheek (much the same way chewing tobacco is held). The methyltestosterone (methyltestosterone is delivered orally, whereas testosterone is delivered through the skin) will gradually be delivered into the bloodstream as the packet hydrates.

Striant is one of the more affordable treatments for low testosterone. 30 applications will cost the patient about $185. However, many patients need to take 2 of the 30mg doses per day, bringing the cost up to around what the other drugs go for.

Due to the fact that this drug is administered orally, rather than topically, there are many side effects that are unique to it. The most common being gum or mouth irritation, gum pain, gum tenderness, headache, or taste prevention. But there are more side effects that can occur. Some of the more serious include prostate cancer, blood clots, stroke, heart failure, and even death. The FDA is currently investigating whether or not testosterone supplements are safe to be used.

Depo-Testosterone is one of the oldest testosterone drugs around.Until recently the majority of those drugs were administered via an injection. However, this drug is administered via injection every 2 to 4 weeks. This makes it a less popular choice for patients. The doctor would administer the testosterone injection at this time. The slow release drug would then dissipate into the blood until the next shot was due.

Androderm is one of the more popular methods of applying the drug.  Instead of requiring an injection, the drug is absorbed through the skin underneath a patch.  Each night the patient applies the patch to a specified location on the body, and removes the patch in the morning.

Androderm has seen a little slower growth than the other two, yet those numbers are still increasing. In 2010 this drug made $64 million in sales; that number grew to $69 million in 2011.

AndroGel, Fortesta, and Bio-T Gel all fall into the most popular form of testosterone treatment.  These drugs are applied via a gel, generally rubbed into the underarm area once per day.  They are easy to apply, have no patches or injections to worry about, and also allow the body to slowly absorb the testosterone.

Androgel is one of the most popular treatments out there. And it can be seen in the explosive growth that it has experienced. In 2010, there were $593 million in sales. By 2012, that number had more than doubled to $1.33 billion.

Gels are the most heavily marketed forms of the drug, yet they are a not any safer to use than the other versions.  In fact, the risk of contact is heightened and the gel may be passed onto someone who does not need testosterone treatment. The companies that manufacture the gel are being faced with testosterone lawsuits due to the serious side effects that come with using the drug.

Axiron is newer to the market, but even this newcomer is making strides. In 2011 the drug had $48 million in sales. By September 2013, the trailing twelve month period saw sales topping $257 million.

All drugs have some unwanted side effects. While annoying, these side effects are mostly harmless (or can be treated by a change of diet or another medication).

• Acne
• Skin irritation, especially with topical gels and patches
• Increased cholesterol levels
• Hypertension (high blood pressure)

The list of mild side effects is quite long. These are all very undesirable side effects, yet they fall into the mild category because they are not life threatening. In addition to the common side effects listed above, those taking part in a low testosterone treatment may also experience:

• Prolonged erections
• Headache
• Changes or swings in sex drive
• Decreased Testicle size and lower sperm count

There are some severe reactions that can accompany testosterone therapy. The most severe is death, often brought about by one of the following conditions:

• Heart disease
• Stroke
• Blood Clots
• Prostate Cancer
• Liver Cancer
• Nausea
• Jaundice
• Sleep Apnea

Unfortunately a good portion of the men who use low testosterone treatments are not made aware of these potentially fatal problems that prolonged use can bring about. These maladies should not be dismissed, as studies have shown that the risk of heart disease increases in those using testosterone supplements, regardless of whether or not they have a prior history of heart disease.

Study findings about an increased risk of heart disease are on top of many other dangerous side effects already known about testosterone boosters. The drugs act to help increase the red blood cell count in the patient. This helps to increase energy and vigor, but it also increases the risk of developing blood clots. A clot that becomes dislodged can lead to stroke, pulmonary embolism, or a whole host of other problems.

There are already hundreds of people who have filed a testosterone booster lawsuit.  There will likely be many more as the facts and dangers continue to surface.

Blood clots are simply the body’s natural way of healing itself. Any small nick or tear in the blood vessel, and the body will clot the blood around the damage until it is repaired. The clot will then naturally dissolve and be reintegrated into the bloodstream. While using a testosterone drug, men will experience an elevated red blood cell count. This elevated count will cause the blood to move a little slower, and cause the blood clots to occur more often, or last longer than necessary. The results of these blood clots can be devastating, and many result in death.

Polycythemia is an increase in the amount of red blood cells.  This increase can be due to an increase in the number of cells, or a decrease in the amount of plasma in which the blood cells travel. A blood test may show that a patient have a decreased level of testosterone, and in order to combat fatigue and other symptoms, they use a low T supplement drug.

One of the ways these drugs help to combat the feelings of fatigue and loss of energy is to increase the number of red blood cells. When a person has more energy, it is because they have plenty of red blood cells in their system. However, when more blood cells are present in the body, the blood moves a little slower through the circulatory system.  This means when the body is naturally fighting tears and cuts in the walls of the blood vessels, the clots that are used to help repair, do not move as fast and do not break down as quickly as they should.  The result is that blood clots can become loose in the bloodstream, and cause problems such as heart attack, stroke, or death. Many men who take testosterone drugs are putting themselves at a significant risk of developing blood clots due to Polycythemia. The drugs now must carry a warning on the label indicating that this risk is present; however, these warnings have not always been present.

A stroke occurs when the brain is not getting the oxygen that it needs to properly function. When a clot forms in one of the arteries or vessels going into the brain, the blood flow may decrease to the point that brain cells begin to die. Depending on which area of the brain is affected, the individual will see different physical or mental consequences.

The downside to an increase in red blood cells is that the blood flow will actually slow down due to too much “traffic.” This slower moving blood will raise the risk of blood clots (something that the body naturally does to repair damage). These clots, when close to the brain, can end up plugging the blood vessel (rather than breaking down as they naturally do) and cutting off the oxygen to portions of the brain. The result is that the individual suffers a stroke.

When a clot plugs the arteries leading from the heart, the heart has to work harder to move the same amount of blood through the body. The harder the heart has to work, the more likely it is that problems will occur. These clots can also lead to higher blood pressure (as the heart tries to push the same amount of blood through a smaller opening).

Deep Vein Thrombosis (DVT) occurs when a blood clot forms within the veins of the body, most often in the legs. If these clots break loose, they travel through the bloodstream and make their way back to the lungs. When the arteries in the lungs become blocked, pulmonary embolism occurs causing damage to the lung tissue. When the lungs are damaged, the rest of the body does not get the oxygen it needs, and can lead to death.

Studies that were released in early 2014, however, show just how dangerous using testosterone therapy drugs really are.  One study showed that those who use Low T drugs are putting themselves at a significantly higher risk of suffering from a heart attack than those who do not take the drug.  The study also found that as the individual ages, the risk increases.

Another study published in the New England Journal of Medicine found that those who took Low T drugs were nearly five times as likely to suffer from an adverse cardiovascular event than those who simply took a placebo.  This study tracked individuals using a testosterone gel for just 6 months.  They found that prolonged use of the drug would increase the risks even more.

One study that was published in early 2013 showed that there is a significantly increased risk of experiencing adverse cardiovascular events before and after taking testosterone therapy drugs.  This concluded that although the studies funded by pharmaceutical companies showed that there was very little risk, in reality that risk was much higher.

Despite if there is a prior history of heart disease or not, these men are suffering from adverse side effects that they were never fully warned about.  This has lead to many men filing a testosterone lawsuit against the company that manufactures the drug (there are currently 10 major brands on the market for testosterone therapy including: Androderm, Androgel, Axiron, Bio-T-Gel, Delatestryl, Depo Testosterone, Fortesta, Striant, Testim).

The FDA is also continuing their investigation of reports that men taking testosterone therapy are subject to an increased risk of heart attack, stroke, and death. This investigation was prompted by several studies that were recently released that followed the lives and supplement use of several men.  These studies showed that there was a considerable increase of heart disease amongst those who used testosterone therapy drugs.