Off-label Use of Medicines as it Relates to Testosterone

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The Federal Drug Administration regulates testosterone as a treatment for symptoms of menopause.

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Episode 52 of the BioBalance Healthcast features a conversation about the use off-label medicines and how that relates to treating symptoms of menopause with bioidentical testosterone. If you missed it, you might want to watch episode 51 titled Testosterone and the FDA.

Bioidentical Testosterone is safe and legal as a treatment for symptoms of menopause.

Off-llabel Drug Use is the common practice of using drugs for purposes not originally approved by the Food and Drug Administration. Terbutaline is a great example. It is an FDA-approved generic asthma drug that was also used an effective way to stop premature labor.

Ramifications of off-label use are sometimes significant beyond the expansion of drug use. Terbutaline is a good example. It has been replaced in the last decade with a similar and more expensive drug for its non-approved use, prevention of pre-term labor. As a result, it was never approved by the FDA for this purpose; until it was replaced, however, it saved the lives of millions of babies.

If a medication has become generic, then it is not patentable, or “own-able” exclusively by any company. As a result, there is no opportunity for profit. It is therefore no longer cost-effective for a pharmaceutical company to pay for this high cost of research on the second use of the drug when the company has no possibility of realizing a return on the investment, much less a profit. And if there is no pharmaceutical company championing a drug for a certain disease, it is unlikely the FDA will approve it for that that purpose, regardless of its proven effectiveness!

Hormones like testosterone fall into a similar category as generic drugs. Because hormones are natural, they are not “unique, and hence not patentable. With no financial incentive to produce unpatentable drugs, there are no investment dollars to support testing in a way the FDA requires. So generic drugs and natural hormones like testosterone remain untested for any but a narrow set of uses.

The first issue centers around the age and medical condition of the patient using it. Most negative reports are related to the use of testosterone in young, healthy men – usually athletes and body builders — who naturally have excellent levels of testosterone, and who are attempting to artificially augment their testosterone beyond normal physiologic levels to increase muscle mass, strength or athletic skill.

This misuse of testosterone is indeed very dangerous, and richly deserving of its bad press, because it turns off the user’s own production of testosterone from the testicles and adversely affects the function of adrenal gland. This can in turn lead to infertility, adrenal failure and a life-long struggle to regain health.

Because testosterone is in demand for these illicit purposes, but can only be obtained legally from a licensed physician, a black market has arisen on the internet where weight lifters and athletes can obtain “forms” of testosterone for injection from the eastern bloc countries. I have interviewed body-builders and lifters who get their “testosterone” to improve their bodies or their competitive edge, but they usually have no idea what is really in these injections except what the “seller” says is in them. Nevertheless, in their desire for a better body than God gave them, or for an illegal leg up on the competition, they inject these knock offs, with risks and side-effects too alarming and too numerous to discuss here.

This, then, is the scariest of all uses of a product labeled “testosterone,” because it is most likely not the same safe, effective, testosterone regulated by the FDA and administered by licensed physicians. It is more than likely a truly unknown testosterone-based substance. Equally concerning is the fact that it is usually administered by an untrained and unlicensed individual, usually a coach or the athlete himself.

If bio-identical hormones like testosterone are essential and helpful, why are they “FDA regulated, but not approved” for hormone replacement in women? The answer is the same as that for generic or other non-patentable drugs: no company has petitioned the FDA to test and approve testosterone replacement for women.

The FDA’s simple regulation of the drug is enough for me at this time. Because bio-identical hormones have been “grandfathered” into the FDA oversight, physicians are free to prescribe them, as I do, for off-label uses. Consequently, millions of women can and do legally and safely use bio-identical hormones, including testosterone, for hormone replacement therapy. Many cannot tolerate any other hormone preparation than pellets.

As the ultimate pharmacists, physicians have the training to look at a drug like testosterone and say, “I know it works for the FDA-approved diagnosis, but this may also work for another condition, or another population (i.,e. women) because of its chemical and physiologic properties.”