Tweet
FDA Requires Prescription Testosterone Products to Include New Warning About Steroid Abuse and Dependence
The United States Food and Drug Administration (FDA) has approved new labels for all prescription testosterone products on the market. The class-wide labeling changes seems to focus on the addition of new warnings over concerns about the risks of steroid abuse and dependence.
The new FDA safety alert – dated October 25, 2016 – reiterated the fact that testosterone and other anabolic-androgenic steroids (AAS) were legally classified as Controlled Substances as a result of the passage of the Anabolic Steroids Control Act of 1990. Using circular reasoning, the FDA cited the legal status of anabolic steroids as as one of the reasons for its new warning about the abuse potential of testosterone.
The FDA seemed concerned that doctors were failing to realize that some of their patients – particularly adolescents, athletes and bodybuilders – may not really need testosterone replacement therapy (TRT) when go to the doctor's office. Instead, these patients are just looking for a way to obtain testosterone legally so that they can obtain safe, pharmaceutical-quality testosterone to include in their stacks with other steroids.
“Testosterone and other AAS are abused by adults and adolescents, including athletes and body builders. Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system.”
The FDA emphasized the risk of abuse and dependence so that doctors will more carefully evaluate their patients. The FDA updated the “Abuse and Dependence” section to cite alleged new evidence and case reports from the published medical literature regarding the abuse potential of steroids.
It is no secret among readers of the various Internet-based bodybuilding forums that there are many individuals who attempt to trick their doctors into unnecessarily prescribing steroids (testosterone). The individuals have normal serum testosterone levels, do not display symptoms of low testosterone and do not require testosterone replacement therapy (TRT). They simply want a pharmaceutical source of steroids to include in their cycles.
Some bodybuilders visit bodybuilding forums looking for ways to artificially lower their serum testosterone levels just so their doctor will give them a prescription. The new FDA warning did not provide explicit guidance for doctors on how to detect such subterfuge. However, it did urge doctors to recognize “the importance of measuring serum testosterone concentration if abuse is suspected”.
While measuring serum testosterone may be useful to detect misuse of testosterone in some cases, it is far from foolproof. Bodybuilders could use therapeutic dosages of testosterone (as prescribed) as part of a steroid stack that includes several other AAS. The serum blood test would indicate normal testosterone levels and would fail to detect the use of other steroids like nandrolone decanoate (Deca Durabolin), methandienone (Dianabol) or trenbolone.
Bodybuilders could also avoid detection if they submit to serum testosterone testing during off-cycle periods, i.e. between their high-dosage testosterone cycles. They could use a 6-month TRT supply for an 8-week steroid cycle and strategically discontinue testosterone prior to doctor-required testing. The serum testosterone levels would be normal and most doctors would never be the wiser.
Of course, an experienced and knowledgeable doctor who understands how the endocrine system works will be able to interpret blood tests and determine whether their patients really need TRT and/or if their patients are artificially manipulating their testosterone levels for the sole purpose of acquiring a testosterone prescription. But most bodybuilders realize that most doctors are not very familiar with testosterone. They know their chances of successfully misleading these doctors are very high.
The United States Food and Drug Administration (FDA) has approved new labels for all prescription testosterone products on the market. The class-wide labeling changes seems to focus on the addition of new warnings over concerns about the risks of steroid abuse and dependence.
The new FDA safety alert – dated October 25, 2016 – reiterated the fact that testosterone and other anabolic-androgenic steroids (AAS) were legally classified as Controlled Substances as a result of the passage of the Anabolic Steroids Control Act of 1990. Using circular reasoning, the FDA cited the legal status of anabolic steroids as as one of the reasons for its new warning about the abuse potential of testosterone.
The FDA seemed concerned that doctors were failing to realize that some of their patients – particularly adolescents, athletes and bodybuilders – may not really need testosterone replacement therapy (TRT) when go to the doctor's office. Instead, these patients are just looking for a way to obtain testosterone legally so that they can obtain safe, pharmaceutical-quality testosterone to include in their stacks with other steroids.
“Testosterone and other AAS are abused by adults and adolescents, including athletes and body builders. Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system.”
The FDA emphasized the risk of abuse and dependence so that doctors will more carefully evaluate their patients. The FDA updated the “Abuse and Dependence” section to cite alleged new evidence and case reports from the published medical literature regarding the abuse potential of steroids.
It is no secret among readers of the various Internet-based bodybuilding forums that there are many individuals who attempt to trick their doctors into unnecessarily prescribing steroids (testosterone). The individuals have normal serum testosterone levels, do not display symptoms of low testosterone and do not require testosterone replacement therapy (TRT). They simply want a pharmaceutical source of steroids to include in their cycles.
Some bodybuilders visit bodybuilding forums looking for ways to artificially lower their serum testosterone levels just so their doctor will give them a prescription. The new FDA warning did not provide explicit guidance for doctors on how to detect such subterfuge. However, it did urge doctors to recognize “the importance of measuring serum testosterone concentration if abuse is suspected”.
While measuring serum testosterone may be useful to detect misuse of testosterone in some cases, it is far from foolproof. Bodybuilders could use therapeutic dosages of testosterone (as prescribed) as part of a steroid stack that includes several other AAS. The serum blood test would indicate normal testosterone levels and would fail to detect the use of other steroids like nandrolone decanoate (Deca Durabolin), methandienone (Dianabol) or trenbolone.
Bodybuilders could also avoid detection if they submit to serum testosterone testing during off-cycle periods, i.e. between their high-dosage testosterone cycles. They could use a 6-month TRT supply for an 8-week steroid cycle and strategically discontinue testosterone prior to doctor-required testing. The serum testosterone levels would be normal and most doctors would never be the wiser.
Of course, an experienced and knowledgeable doctor who understands how the endocrine system works will be able to interpret blood tests and determine whether their patients really need TRT and/or if their patients are artificially manipulating their testosterone levels for the sole purpose of acquiring a testosterone prescription. But most bodybuilders realize that most doctors are not very familiar with testosterone. They know their chances of successfully misleading these doctors are very high.
Comment