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

If 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.