FDA Reviews Safety of Testosterone Therapy For Men
Posted By: Dr. Gary Bellman on March 5, 2014
Many of us have seen commercials running about testosterone therapy; either promoting a product or questioning its effectiveness. The negative stigma seems to grow as more companies are targeting older men with products for testosterone replacement that promise to help them ‘become young again.' Among the television ads, you may also have seen commercials asking the public to take legal actions for adverse effects.
The FDA is also giving testosterone therapy a second look. Two studies have prompted it to review the impact of these drugs to see whether the treatments were associated with an increased risk of stroke, heart attack and death. The regulator was already monitoring the situation, but said in a statement that this latest move is meant to reassess this safety issue.
The assessment may affect drugs such as AbbVie's market leader AndroGel and Lilly's Axiron; The studies of note include a Veterans Affairs study of men who had low serum testosterone, an average age of 60 and underlying cardiovascular disease. The study indicated testosterone upped the risk of heart issues and death by around 30%. A second study of older and younger men with pre-existing heart disease found the risk of heart attack doubled among this patient group for men who were at least 65 years old and on testosterone therapy.
Testosterone is the hormone responsible for the normal development of male sex organs and it also plays a major role in men’s sexual drive, energy levels and attitudes. As they age, men may experience a decrease in their testosterone levels, which can translate to a low libido, depression and lack of motivation, reduced muscle strength and bone density, and in some cases, memory loss.
Although testosterone replacement therapies have been around for more than 20 years, there has been an increase in the number of products available and in the demand for those products.
We are also seeing more and more sudden drops in testosterone levels as obesity rates go up. That is because body fat causes testosterone to metabolize faster.
But while there are replacement treatments that can help, they have to be done properly and under a doctor’s supervision-- ordering testosterone supplements over the phone or on the Internet is not recommended. Many of those products aren’t regulated by the Food and Drug Administration.
The most important part is to determine that an individual has low testosterone levels to know if they need a treatment. If you are ordering something on your own, most likely you are not seeing a doctor that can tell you if you need a replacement in the first place.
There are three main options to get testosterone in the body, once the hormone deficiency has been diagnosed. The treatment can be administered through an injection, patches, gels and intramuscular pellets.
Patients who opt for the gel apply it daily on their bodies, usually the shoulder or stomach, and should wait for 10 minutes until it is absorbed. Then, the body slowly releases the synthetic hormone into the bloodstream. The injection can be self-administrated, usually every two or three weeks. The pellets require a minor surgical procedure, usually placed under or near the buttocks.
Once a patient is undergoing testosterone replacement treatment, he is still not on his own. By monitoring each patient, we can insure that the hormone levels are regular and that the treatment is working.
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