FDA Warns Men of Serious Side Effects from These Drugs—But Keeps Them on the Market

April 17, 2012
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Sexual DysfunctionIf supplements caused such adverse events, they would be banned immediately! Fortunately there are excellent supplement alternatives to these drugs.

Two popular drugs—Proscar, used to treat an enlarged prostate, and Propecia, which is used to treat male pattern baldness—will now have new warnings from FDA on their labels for causing very undesirable sexual side effects even after you’ve stopped taking the drug!

Proscar’s label now mentions decreased libido, while Propecia’s label includes warnings for libido, ejaculation, and orgasm disorders that may hang around well after the patient has discontinued the drug. Both labels describe reports of male infertility and/or poor semen quality, though these problems normalized or improved after drug discontinuation. Can you imagine what would happen if a natural supplement caused sexual side effects even after you stopped taking it?

Millions of Americans relied on the amino acid l-tryptophan, a precursor to serotonin, for decades to relieve depression, anxiety, and PMS, as well as to control pain and induce natural sleep. But after a problem with one Japanese manufacturer of tryptophan, it was completely banned for sale to consumers in 1990—and stayed banned for the next decade.

Note the interesting timeline: tryptophan is banned on March 22, 1990. Four days later, on March 26, 1990, the cover of Newsweek proclaims Prozac as “a breakthrough drug for depression.” Prozac, of course, also involved serotonin.

We should clarify one thing, however: FDA did not completely ban the use of l-tryptophan in humans—FDA granted the pharmaceutical industry the protected right to use l-tryptophan in hospital settings! Manufactured by Abbott Laboratories, the amino acid injectable solutions Aminosyn and Aminosyn II contain as much as 200 mg of l-tryptophan. So even during the 1990s, you could get tryptophan—you just had to pay exorbitant prices for it from Big Pharma!

It’s all about patent protection. As we noted recently, for a supplement to make specific health claims, it has to go through outrageously expensive drug trials—a cost that supplement manufacturers could never recoup, since food and supplements are natural products and cannot be patented. Without a patent, anyone can sell them, so paying as much as a billion dollars for a drug trial is essentially money down the drain. Only the drug companies have that kind of budget, so they merely put the supplement into some form that they can dispense as a drug, patent it, and prevent others from selling the drug. Then they can charge whatever they want.

Sometimes the pharmaceutical company goes even further. They not only get a patent on their drug—they also get the government to ban the supplement on which the drug is based.

This is precisely what happened to pyridoxamine, one of only three natural and bioavailable forms of vitamin B6. And it could also happen to P5P—the ultimate form of natural B6 which all other forms of B6 must convert to before being used by our body. Without P5P we would all die, yet the FDA may ban it as a supplement in order to turn it into a prescription drug. Please see our Action Alert on P5P.

In the case of prostate supplements, the pharmaceutical companies did not attempt to ban the underlying supplements, so they are still available, and they do not appear to create risks similar to the drugs. Why are they low-risk? Could it possibly be because the supplements are natural substances we have co-evolved with, while the drugs are synthetic, new-to-nature substances that our bodies consider foreign?

Finding a good treatment for an enlarged prostate, also known as BPH or benign prostatic hypertrophy, is extremely important for men, as BPH happens to almost all men when they get older, causing bladder problems, frequent urination at night (thus disturbing sleep), and sometimes other, more serious problems. The steps taken to prevent an enlarged prostate gland may also reduce the risk of contracting prostate cancer.

To keep your prostate healthy, the Life Extension Foundation suggests saw palmetto extract, which protects against prostate enlargement caused by too much of the male sex hormone dihydrotestosterone (DHT). A very large, double-blind trial conducted in 87 different urology centers in nine European countries found that patients who took 160 mg of the extract twice daily reduced their BPH symptoms as much as those who took Proscar—but with far fewer libido, impotence, and ejaculatory disorders.

In addition, LEF includes in its Natural Prostate formula extract of the root of stinging nettle (Urtica dioica, which inhibits the conversion of testosterone into estrogen and the related proliferation of prostate cells in response to estrogen), extract of flower pollen, 5-Loxin, a form of the herb boswellia, extract of pumpkin seed oil, pygeum (from tree bark), lycopene (from tomato extract), phytosterol complex, a proprietary blend of lignans, and boron.

Natural biomedical researcher and physician Jonathan V. Wright, MD, co-author of The Patient’s Book of Natural Healing, recommends essential fatty acids for BHP—these fatty acids also prevent cardiovascular disease, control inflammation, help the brain, and help maintain pliable skin as we age. He also suggests that anyone taking fish oil take vitamin E (mixed tocopherols, not just alpha-tocopherol) at the same time each day. Dr. Wright further notes that men suffering from an enlarged prostate are often deficient in zinc. If taken in higher doses, this should be balanced with some copper. Please see his newsletter, Nutrition and Healing, for further information.

As for natural alternatives to Propecia, the male pattern baldness drug that FDA issued the new warnings about, it should be noted that male pattern baldness sufferers may have a genetic sensitivity to DHT. Hair follicles sensitive to DHT begin to miniaturize, shortening the lifespan of each hair follicle affected. So prostate supplements that control the conversion of testosterone into DHT (like saw palmetto) may also retard male pattern baldness. Do the same things you’d do for a healthy prostate, and you’ll be making your hair healthy as well! For baldness, the Life Extension Foundation’s integrated protocol includes l-lysine, l-arginine, saw palmetto, green tea extract, and grape seed extract.

We can be grateful for the existence of all these supplements, which have a great deal research behind them, and have improved the life of millions of men. They stand in stark contrast to the failed prostate and baldness drugs.

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12 Responses to “FDA Warns Men of Serious Side Effects from These Drugs—But Keeps Them on the Market”

  1. Blanche Sappenfield says:

    BY FAR…. most helpful form i’ve found on the internet Over all. The Part about needing PCT i learned the hard way with the lapse and going to original size.. it’s not fun.

       0 likes

  2. Mike88 says:

    From all oif the reports I have read concerning the FDA and what they ban or don’t ban, I see absolutely no reason to trust anything the FDA does, especially since they are actually paid by the Pharmaceutical Industry to approve their Drugs.
    The FDA is actually on the payroll of the Pharmaceutical Companies hence they are working for the Pharmaceutical Industry and not in the best interest of the citizens of this nation. Just one more government agency I can’t trust to do what is right for the people.

       3 likes

  3. Bob Oldow says:

    It’s the second time when i’ve seen your site. I can gather lots of hard work has gone in to it. It’s actually wonderful.

       1 likes

  4. Sherry Moore says:

    I was told by my natural health practitioner that any problems with the reproductive organs involved iodine deficiency and estrogen dominance. Iodine was fear-mongered in the 1960s and 70s and removed from bread supplementation. That is when we became deficient and started having all kinds of problems with the reproductive organs and stopped detoxing synthetic molecules, some of which mimic estrogen.

    The government can’t pass a low that would bankrupt an industry, so iodine supplementation will not be mandated by law and you can’t talk about this on TV because pharmaceuticals would withdraw their advertising dollars. Do a search for iodine fulfillment therapy and read all about it. I have a blog on HUB pages: What started our health epidemic in the 1970s?

       1 likes

  5. Pauline Harding MD says:

    The news that P5P could be banned by the FDA is incredibly distressing. DO YOU KNOW HOW IMPORTANT IT IS? Of course, you do. So, does Big Pharma. Does anyone at Natural Health have the time and energy to start a petition using SignOn.Org? If SignOn.Org accepts the petition as one to circulate to it’s hundreds of thousands of subscribers, huge numbers of individuals are educated about the problem and the pressure mounts on the FDA.

    What I know about P5P:
    Individuals who inherit a second toe that is as long as or longer than their big toe also inherit an ability to convert Vitamin B6 into its usable form: P5P. Without P5P these individuals are more likely to develop: digestive problems, inability to absorb Vitamin D and calcium, mitral valve prolapse and ‘unexplained’ heart flutters, early balding and low testosterone and prostate enlargement, endometriosis and fibroid tumors of the uterus, tooth grinding, multiple sclerosis, and skin and vision problems.

    The military discovered this after World War I when they noticed that admirals and generals got sick from nerve gas faster than the average soldiers and sailors. Research showed that admirals and generals pretty much all have: long second toes and a faint line down the middle of their tongues, higher intelligence and leadership ability, a tendency to see long-term consequences and the big picture, and P5P deficiency, not to mention renal wasting of taurine.

       1 likes

  6. Jim Reisinger says:

    I am amazed that the article did not mention Beta Sitosterol. I have been using Beta Sitosterol for many years now, after learning that it was much more effective on my BPH than Saw Palmetto.

       0 likes

  7. Gertrude Lamb says:

    It is not enough to tell us what the FDA and others are doing that is wrong. Tell us what we can do to stop them. Calling one’s congress person is NOT one of those effective steps, I learned…
    Tell us what we can DO that WORKS, not just what is wrong in the belief that contacting one’s congress person will have any effect whatsoever. My Senator Olivia Snowe had no connection to FDA and her phone-answering lady said so very plainly. My Representative had even less. The only committee with any connection to FDA had NO contact info listed on their website, NO mention on their agenda of anything related to FDA or its intended massacre of all non-Pharma health products, no way to let the committee know my sentiments. Not even a postal address to write to.
    And no legal consequences to their known and publically stated misconduct (Watch the Netflix streaming movie, “Burzynski” in which proof is shown that the FDA and NIH working with FDA broke several laws–including suborning a judge in a case in which FDA was one of the parties, suborning and extorting false reporting from scientists in research studies, and so on.) So what if “we-the-people” disapprove of what FDA or other agencies or state/federal legislatures do? They don’t have to behave–and we can’t make them.
    If ANH-USA knows any way to actually make a difference in the outcome–TELL US WHAT TO DO. Don’t just sit there and bemoan the facts–tell us what we can do that makes a difference. Other than just griping to one’s congress person that FDA isn’t playing nice….!

       5 likes

  8. Alan says:

    In the first place, it is known to alternative medicine practitioners, that male pattern baldness (hair loss on the crown of the head) is caused by conversion of Testosterone to DHT and is rather easily corrected by taking Beta-Sitosterol (can be purchased very cheaply from Swanson supplements on the internet). This same product will improve sex drive in both men and woman who are converting Testosterone to DHT.. It’s not genetic, in my opinion, based on my patient base that is a very wide cross-section. Using the same person model for comparison I have found that it is rooted, or a function of low Thyroid function or Hypothyroidism.
    Regarding enlarged Prostate; when is the entire medical field, both allopathic and alternative, going to stop trying to change Nature’s basic law of all Mankind. Pick up and read “Hypothyroidism, The Unsuspected Illness” by Broda O. Barnes M.D. who spent 50 years of his professional life on this very subject. Or Guy Abraham M.D. or David Brownstein M.D. I’ll run out of room if I name them all who really have the answers. The Prostate is analogous to the Thyroid in that Iodine deficiency causes both Goiter (an enlargement of the Thyroid) and enlarged Prostate for the very same reason: severe Iodine deficiency. The Prostate is the second largest site beyond the Thyroid for Thyroid Hormone Receptors. When is the rest of the medical community going to get this undeniable medical fact correct?

       0 likes

  9. GARY BOOTH says:

    Both of these disorders are caused by the same thing, a simple deficiency disorder. As a male gets older, he produces less and less Progesterone. Now, progesterone is the precursor of testosterone and estrogen. It is also an antagonist for estrogen. Read “What your doctor may not tell you about Menopause” and “What your doctor may not tell you about Pre-menopause”. I read these books 15 years ago, and extrapolated them to the hormone aging disorders in men. It worked! I have been taking “Natural Progesterone Cream” supplements for these 15 years. My hair was restored, my libido was restored, my prostate returned to normal. I have a vigorous sex life at the age of 77.

    Bottom line, neither the drugs you mention nor the supplements answer the question of “What changed”

    Don’t use drugs or supplements that change the way your body works. Instead, beat the so called “Age Related Disorders” into the ground by providing the body what’s missing, or as I like to refer to them, “Age related essentials”.

       0 likes

    • Carl says:

      Gary, How are you using the “Natural Progesterone Cream”?? Is that something you rub into your
      scalp??

         0 likes

  10. Michael Carpenter says:

    Have seen any of the FDA people come to the people and tell them anything in person.They will go to the Co. and pickup their check.If we the people could
    check their Bank Account.they would have alot of checks from Pharms.
    Michael

       0 likes

  11. Nag Hammadi says:

    Saw Palmetto does nothing but help empty the bladder.! It is a diuretic same as caffeine, alcohol and
    vitamin C.

       0 likes

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