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If you ever doubted your doctor because she wrote a script that you later "Googled" and found was not FDA approved, I hope you trusted your doctor enough to realize that she wouldn't recommend any medication that would hurt you….
What is an unapproved use of a drug, also called "off-label"?
Unapproved use of an approved drug is often called "off-label" use. This term can mean that the drug is: Used for a disease or medical condition that it is not approved to treat, such as when a chemotherapy is approved to treat one type of cancer, but healthcare providers use it to treat a different type of cancer.
The drugs that are not approved by the FDA, yet are commonly used, have been used for decades before the 1964 law that required new drugs to go through extensive and very expensive testing before their release to the public. The operative word is NEW DRUGS AFTER 1964.
Today I will talk about the safety of non-FDA approved drugs because they are:
- Older cheaper drugs used for many diseases and conditions before 1964 and are still used
- Drugs that are approved for one use, or one condition, but not for other conditions that it is effective and safe for.
- Drugs made by compounding pharmacies for diseases that the FDA has not approved a drug for, but there is research backing the drug and years of safe use.
First, before we discuss the non-FDA approved drugs, I will discuss the safety/risks of FDA approved drugs, and why FDA approval doesn't mean a drug will do no harm or even that it is effective for the use it is approved for.
A little background will help you understand the problem and the reason an FDA approval does not necessarily mean a drug is safe. Since 1964, a law was passed that established testing prior to a drug being approved by the FDA became mandatory. Since that time several drugs that survive FDA approval and are released but are later removed or banned after their FDA release when the public finds side effects that the FDA didn't discover in their trials. One such drug is Fen-Phen, Fenfluramine/Phentermine. This drug was released during my time practicing medicine and was withdrawn after one study claimed it caused heart valve disease…In the end the "one post approval study" that claimed that heart valves were affected by this drug that caused its bann was found to be false. The withdrawal of the drug followed one study by a single cardiologist from Kansas City had reviewed all of the cardiac valve echo tests and falsified the results to make Fen-Phen appear dangerous to heart valves, when in reality it wasn't. She lost her license, but the FDA never put Fen-Phen back on the market! The FDA hates to be wrong twice, so they never allowed this drug back on the market after its removal.
Other mistakes made by the FDA include not allowing women in the studies to approve a drug before 2014 which ignores or misses all of the side effects or lack of effectiveness for a drug when taken by women. Despite all the expensive testing before the release of a drug by the FDA, many drugs not tested on women were later often found to have severe side effects only on women. A few examples follow:
You might have heard of the FDA approved drug Ambien that causes many women to experience "night eating", sleepwalking, and night terrors, while their male counterparts were not affected, so because they only tested men the drug was approved. In retrospect it should have been tested on women as well, and then either not passed through the FDA or should have had a black box warning for women.
It takes years get action from the FDA, notifying doctors of these side effects. Women were not included in testing for any drugs except female hormones until 11 years ago, but no other drugs. Before 2014 all (non-hormonal) drugs that passed the FDA were not tested on women so the effect on women was unknown until it was tested on the public.
The FDA left women out of drug-trials because it viewed women as "mini men", or they didn't consider us important enough to test new drugs on…OR worse, they believed we were too complicated to easily test us because of pregnancy, menopause and other hormonal swings that normal healthy women have. In any case, we are now suffering their decisions, when a medication works one way for men and another way for women!
Finally, we are tested when drugs are being evaluated for approval by the FDA. Professional women have achieved a level of authority in medicine and pharmacology (2025) and are weighing in on the inequity. Women in the medical profession and the public are pulling back the curtain on the side effects of FDA approved drugs that are experienced by women only!
Slowly, study by study investigators are now publishing the side effects and problems for women with FDA approved drugs….yet these findings are not included in the warnings on most of these drugs, even now over 15 year after they became obvious to the doctors who treat women!
Drugs that either don't work for women, or that have severe side effects include that were approved before 2014.
- All statin drugs for high cholesterol (Crestor, rosuvastatin, atorvastatin, etc.) cause women to have muscle breakdown and muscle pain.
- Synthroid (levothyroxine), doesn't cure the symptoms of hypothyroidism in 80% of women, but just makes the TSH lower, so it appears as if it is working! This leads doctors to tell women that their symptoms are all in their heads!! Wrong. It is the wrong medicine. Women have enzymes that differ from men that make it difficult for them to convert the inactive form (T4) into the active form (T3), so we can't convert Synthroid (all T4) into the active form. Synthroid, the FDA approved drug for hypothyroidism, shouldn't be given to most women. Women should be given the non-FDA approved drug Armour Thyroid or NP thyroid that have both T3 and T4 in them!
- Ambien
- Prednisone and other oral steroids
We have reviewed the lack of testing on women before 2014, now we will discuss safe drugs that have been used for decades even before 1964 when the FDA required testing for FDA approval?
Older, yet effective and inexpensive drugs have been tested by the public, some for almost 100 years that have saved thousands of lives, yet they are not given the FDA stamp of approval! In fact, the FDA tries to put these drugs out of circulation, replacing them with very expensive drugs that are new!
Or they just shut them down, because they are not FDA approved. Young doctors are told not to use them by their medical schoolteachers who rarely have experienced these medications in private practice…. These doctors in training don't know the history of older safer, cheaper drugs, or even why the FDA tells them avoid them. They comply not knowing why, so you are left with no drug that works for you, or you pay 3-10 times the amount for a newer FDA version of the older drug which may even have more side effects.
Some of these older very effective and cheap drugs are
- Penicillin,
- Nitroglycerine for chest pain,
- Morphine (pain),
- Phenobarbital (seizures),
- Codeine,
- Armour Thyroid,
- hormone injections including estradiol injections and testosterone,
- Thorazine for psychiatric use,
- (Pitocin) oxytocin for labor, lactation support and Autism
- Colchicine:Used to treat and prevent gout.
- Progesterone in oil (IM)
- Estradiol in oil (IM)
- B12 for injection
- Testosterone Cypionate for injection
- Compounded Estradiol in any form
- Compounded Testosterone for women
These drugs have been used for so long that any safety risks or side effects have been found through the use of these drugs in the population. Yet the FDA won't grandfather them in and approve them based on their history!
What do doctors do when the drug the FDA has approved a drug that doesn't work for a group of their patients (gender, race, blood type, etc.)? What happens when a doctor can't find a drug that is FDA approved needed to treat a condition she is faced with?
Why do we as citizens, allow the government to have power over doctors who are already controlled by their state licensing boards as to what medications they? Lastly Why do taxpayers allow a government agency that they fund with tax dollars control their health by banning, or not approving drugs, or banning one drug so an outrageously expensive drug is put in its place?
Compounded Medications/ Compounding Pharmacies:
These drugs are made by mixing ingredients to meet individual patient needs and are not subject to premarket review for safety, effectiveness, or quality. However, they ARE subject to the success or failure for which they were prescribed.
If a doctor prescribes a compounded drug that doesn't work, she is apt to be confronted by her patient who is not getting the expected results. Compounding pharmacies usually don't get paid by insurance, so patients are more invested in getting a drug that works and that is one of the big reasons that Compounded medicines are at least as good or better than big pharma or generic drugs.
I absolutely could not successfully treat the thousands of women and men that I have without compounding pharmacies. They compound hormones/drugs that are safe and effective, mostly hormones that can't be patented because they occur in nature and won't ever be made by big pharma. More than that, big producers of drugs can't produce in mass quantities many doses of a certain hormone like compounding pharmacies do. Compounding pharmacies provide what people need and they continue to do so because patients prefer their dosing and quality. FDA approved Generic Drugs can be legally 25 % lower dose than what they say they are. That would be a big problem if my compounded pellets had that kind of variability. People might need pellets every 2months or every 5 months instead of every 4 months..it would be like guessing what you need ahead of time…..I believe dedicated compounding pharmacists are more accurate than any generic on the market.
Compounding pharmacies: Unsung Heros
Compounding pharmacies serve the public when big pharma fails and hasn't developed a safety net for production if they have a problem and the FDA shuts them down. That situation leaves patients who take their medications, without an alternative.
Compounding pharmacies step into the breech when big pharma has a problem with a particular drug and stop making a drug (e.g. Lidocaine, B12 injectable, IV Fluids, to name a few shortages and no production that have occurred in the recent past). What if patients couldn't get the meds they need, and if there were no compounding pharmacies—Chaos and suffering and dying patients would closely follow!
The FDA is Fickle and is not on your side!
For years the FDA did not approve of Bioidentical estrogen and testosterone in any form, and just a few months ago all of a sudden, long after they scared women from taking the hormones they needed to improve their length of life and quality of life, they decided bioidentical hormones are better than the FDA approved hormones!!! That is a little too late. Some of us will never forget the stress lack of approval of compounded hormones caused for doctors and patients alike. Other doctors criticized us and now most of them aren't even in practice anymore. Maybe the FDA read my blog!!!
Compounded hormones have been approved by the masses of women who have taken them under my signature!
Compounded BI hormones are medications with a long track record and should not have to be tested with the bloated expense required of testing for the FDA.
For Gynecological Disorders that don't have an FDA approved hormone drug because testosterone and estradiol have been used for so long that they don't need testing. If there was a significant problem with them their history of use of over 5-7 decades has proven the efficacy and safety of the female hormones for treatment and hormone replacement.
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- For Psychiatric Disorders: Some patients need compounded ketamine products for conditions like severe depression, despite lacking FDA approval for these uses and potential risks, yet it has been used for this purpose for decades and was used for childbirth for almost a century, until epidurals and saddle blocks took their place.
- Testosterone for women still is not recognized as a female hormone even though women produce over twice as much Testosterone as Estradiol when they are in their fertile years. Replacement of T with bioidentical T pellets offers a treatment for dozens of symptoms women face after age 40, and it prevents the diseases of aging: osteoporosis, heart disease, sarcopenia, frailty, diabetes and more that have not been addressed by mainstream medicine and the FDA.
- Over a decade ago, the FDA turned down the approval of testosterone patch after over 3 years of positive research studies, the FDA said they didn't approve T for women is because the side effect of T for women, facial hair, was dangerous for women.…I cry B—–S—-! That is really men not wanting to share testosterone replacement with women.
I say leave us alone and let women and their doctors determine what they need. It is proven that only 5% of all professionals in any profession are not trustworthy, so give doctors their due and trust that we are looking for answers to our patients' problems that you don't even know about! The FDA is paid for by us…everyone in this country. I say hands off! Speed up the approval process or forget it for older drugs and BI hormones! ~
