Should FDA Approval Limit the Use of Ancillary Medication for TOT?
By Jay Campbell
November 1st, 2018
SERM’s (Selective Estrogen Receptor Modulators) and AI’s (Aromatase Inhibitors) are ancillary drugs used to eliminate potential side effects of Testosterone Optimization Treatment and improve its performance. These ancillaries are quite potent, so there must be a specific diagnosed medical need to use them. But, more and more physicians are using them, adamant about the fact that it helps their patients. However, neither their benefits nor their continued use among patients has persuaded the FDA to approve these medications for full use. With clear benefits on the one side, and authority on the other, should FDA approval play a significant role in the use of ancillary medication during TOT?
The Problems with FDA Approval
SERM’s and AI’s have not been FDA-approved for use in men, TOT physicians prescribe them for ‘off-label’ use. Since some of them are generic medications in most markets, it is unlikely that a drug company would pursue FDA approval for using these drugs in men because of the limited profit incentive. FDA approval is expensive to obtain, so without the motivation for profitability, a drug company is unlikely to seek approval despite the obvious therapeutic benefits that exist for a given drug.
Overcoming FDA Approval
Just because something isn’t FDA-approved doesn’t mean you and your doctor can’t discuss a medication’s potential therapeutic benefits. In the USA, doctors have some dispensation to prescribe non-FDA approved drugs at their discretion if they feel it will benefit the patient. SERM’s and AI’s were initially designed to treat breast cancer in women, and so when these medications are used in male endocrine systems, the patient needs to be closely monitored. However, they are usually well tolerated. It is essential to work with a TOT physician who is familiar with how these drugs interact with the human body.
Use with Caution
Understanding this, you should insist your doctor performs regular DEXA scans to assess any bone mineral loss or spinal degradation if you are using Arimidex while also on TOT. Most TOT experts aren’t fond of AI medications and recommend physicians follow a minimum effective dose (MED) principle. You should ALWAYS act with the primary goal of weaning off the AI completely, as soon as there are a therapeutic range and absence of side effects. Your doctor will analyze your lab work and symptoms, and prescribe you any necessary ancillary medications (when your symptoms and blood values warrant it.) They will also discuss the potential side effects and their ramifications before you start taking them.
FDA approval shouldn’t stand in the way of your health if your physician believes a specific type of medication can help you. There are many positive sides to applying SERM or AI during Testosterone Optimization Treatment that minimizes side effects when used under professional supervision. Get The TOT Bible today, and show it to your medical doctor. Discuss the benefits TOT can have on your body, and if you will need to use ancillary medication during the treatment. Be open about it with a professional you trust, and make your decisions about your body.