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Some aging men may have welcomed the news that the US Food and Drug Administration has approved oral treatment with testosterone for hypogonadismor low gonadal testosterone production. After all, with commercials bombarding them with affirmations attribute all their ills to "low T"And urge them to"ask their doctor"In this regard, aging men might think that it is high time for a pill to appear instead of dealing with a messy gel.
Unfortunately for them, the agency claims that the recently approved drug, Jatenzo (Testosterone undecanoate; Clarus Therapeutics) is not intended to reduce the number of age-related testosterone tests. Instead, it is intended to treat people with hypogonadism for less common causes, such as pituitary tumors or Klinefelter syndrome. This form of testosterone had already been approved for injection. AVEED (Pfizer).
The pituitary gland sends messages to gonads that regulate the release of hormones, and tumors can increase or decrease the volume of these messages inappropriately. Klinefelter syndrome is the name given to the series of traits resulting from the carriage of a Y chromosome and two X chromosomes. One of the characteristics of Klinefelter may be smaller testis than the average testis that produce low levels of testosterone . Having this condition is badociated with increased risk of obesity, insulin resistance and mortalitywhich explains why the FDA considers that the benefits of Jatenzo outweigh the risks for this population.
The disadvantage of Jatenzo, said the FDA in a statement, is that, as with all testosterone treatments, the risks of increased blood pressure, which in turn constitutes a risk of cardiovascular disease and death. For people with pituitary tumors or Klinefelter syndrome, it is possible that the benefits of the drug outweigh these risks. The FDA concluded, however, that this was not the case for older men who experience the typical effects of aging. About one-third of older men may suffer from hypogonadism.
Cardiovascular risk is sufficient for the drug label to carry a boxed warning, as Aveed does, which is only available through the FDA's tightly controlled risk badessment and risk reduction strategy. The agency insists that clinicians & nbsp; keep in mind the cardiovascular risk of each patient and ensure that their blood pressure is controlled when the medication is taken. People with conditions considered as indications of Jatenzo use often already use another form of testosterone (injection or skin patch). Therefore, their risk may not vary when switching to the oral pill. Of the 166 participants in the Jatenzo trial that lasted 4 months, almost 9 out of 10 experienced increased testosterone levels during normal drug use.
In addition to the risk of blood pressure badociated with testosterone treatment, trial participants reported side effects such as headaches, reduced "good" cholesterol, nausea, and increased blood pressure. 39, antigen specific to the prostate.
Invariably, men young and old who do not have the conditions listed for this drug will look for it for non-label use, and these drugs have long gone around bodybuilding communities. In younger men with no physical indication of treatment, the use of an external source of testosterone may result in the permanent discontinuation of the testes, as well as sterility and mask condition causing low testosterone levels.
Guidelines of the endocrine society Say that hypogonadism should only be diagnosed if the signs and symptoms of it are clear and if the serum testosterone level is low and it stays low after repeated measures. They explicitly recommend not prescribing testosterone treatment in men 65 years of age or older who have low testosterone levels, but say that if early morning symptoms and testosterone levels are still low, it may be considered .
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Some aging men may have welcomed the news that the US Food and Drug Administration has approved oral treatment with testosterone for hypogonadismor low gonadal testosterone production. After all, with commercials bombarding them with affirmations attribute all their ills to "low T"And urge them to"ask their doctor"In this regard, aging men might think that it is high time for a pill to appear instead of dealing with a messy gel.
Unfortunately for them, the agency claims that the recently approved drug, Jatenzo (Testosterone undecanoate; Clarus Therapeutics) is not intended to reduce the number of age-related testosterone tests. Instead, it is intended to treat people with hypogonadism for less common causes, such as pituitary tumors or Klinefelter syndrome. This form of testosterone had already been approved for injection. AVEED (Pfizer).
The pituitary gland sends messages to gonads that regulate the release of hormones, and tumors can increase or decrease the volume of these messages inappropriately. Klinefelter syndrome is the name given to the series of traits resulting from the carriage of a Y chromosome and two X chromosomes. One of the characteristics of Klinefelter may be smaller testis than the average testis that produce low levels of testosterone . Having this condition is badociated with increased risk of obesity, insulin resistance and mortalitywhich explains why the FDA considers that the benefits of Jatenzo outweigh the risks for this population.
The disadvantage of Jatenzo, said the FDA in a statement, is that, as with all testosterone treatments, the risks of increased blood pressure, which in turn constitutes a risk of cardiovascular disease and death. For people with pituitary tumors or Klinefelter syndrome, it is possible that the benefits of the drug outweigh these risks. The FDA concluded, however, that this was not the case for older men who experience the typical effects of aging. About one-third of older men may suffer from hypogonadism.
Cardiovascular risk is sufficient for the drug label to carry a boxed warning, as Aveed does, which is only available through the FDA's tightly controlled risk badessment and risk reduction strategy. The agency urges clinicians to keep in mind each patient's cardiovascular risk and to ensure that their blood pressure is controlled when the medication is taken. People with conditions considered as indications of Jatenzo use often already use another form of testosterone (injection or skin patch). Therefore, their risk may not vary when switching to the oral pill. Of the 166 participants in the Jatenzo trial that lasted 4 months, almost 9 out of 10 experienced increased testosterone levels during normal drug use.
In addition to the risk of blood pressure badociated with testosterone treatment, trial participants reported side effects such as headaches, reduced "good" cholesterol, nausea, and increased blood pressure. 39, antigen specific to the prostate.
Invariably, men young and old who do not have the conditions listed for this drug will look for it for non-label use, and these drugs have long gone around bodybuilding communities. In younger men with no physical indication of treatment, the use of an external source of testosterone may result in the permanent discontinuation of the testes, as well as sterility and mask condition causing low testosterone levels.
Guidelines of the endocrine society Say that hypogonadism should only be diagnosed if the signs and symptoms of it are clear and if the serum testosterone level is low and it stays low after repeated measures. They explicitly recommend not prescribing testosterone treatment in men 65 years of age or older who have low testosterone levels, but say that if early morning symptoms and testosterone levels are still low, it may be considered .
