Brain Brawn & Body Your Daily Dose May 23

logo728

FMCW prostate miller banner ad


Dear Reader:

Men, today we look at some products we buy and ingest to enhance or improve our sexual prowess or our appearance. Some of what we take may help us to feel better about ourselves.

But how much do we know about the possible risks we face when ingesting some of these substances?

The following articles are meant to alert you to concerns raised by medical authorities who caution us to know more before we buy and take supplements.

Your long term health could depend on it.   

Testosterone Supplements May Hurt Male Fertility

By Randy Dotinga

HealthDay Reporter

Testosterone supplements are touted as a cure for low libido, but men who take them may reduce their odds of fathering a child, new research suggests.

Many men who sought infertility treatment at two U.S. clinics reported taking prescription testosterone supplements, according to a new study. And in most cases their sperm counts skyrocketed after they stopped taking the male hormone.

The study, limited to a pair of clinics in Alabama and Kansas, looked at the years 2005 to 2011. The researchers don't know if testosterone supplements, which continue to gain popularity, are contributing to even more cases of infertility now. Nor is it clear whether the hormone is harming fertility across the nation.

Still, the research suggests that testosterone spells trouble for many American men who want to have children, said study co-author Dr. Peter Kolettis, a professor of urology at the University of Alabama at Birmingham. "This has become a preventable cause of infertility."

Hidden Risks of Erectile Dysfunction 'Treatments' Sold Online

Men looking online for "dietary supplements" to treat erectile dysfunction (ED) or enhance their sexual performance should beware: these products may contain prescription drugs or other undisclosed ingredients that can be harmful.

"The number of these problematic products available on the Internet appears to be increasing," says Michael Levy, director of the Food and Drug Administration's (FDA) Division of New Drugs and Labeling Compliance. The division is part of the Office of Compliance (OOC) in the agency's Center for Drug Evaluation and Research (CDER).

Many consumers perceive these products as completely safe because they are often sold with labeling, suggesting that they are all-natural alternatives to prescription drug products that have been approved by FDA for treating ED.

But these products may be laced with potentially hazardous ingredients that aren't noted on the label.

Since 2004, FDA has become aware of several such "dietary supplements".

Viagra Ingredient Found

Working with other FDA components, the division's Internet and Health Fraud Team led an Internet survey in which more than one-third of purchased "dietary supplements" claiming to spur sexual enhancement or treat ED contained undisclosed prescription drug ingredients or similar substances.

Six of the 17 products contained sildenafil (the active ingredient in Viagra) or a substance similar to either sildenafil or vardenafil. Vardenafil is the active ingredient in Levitra, another FDA-approved prescription drug that treats ED.

Mark Hirsch, a medical team Leader in CDER's Division of Reproductive and Urologic Products, says this undisclosed presence of prescription drug ingredients—and similar compounds known as analogs of the drugs—can lead to serious side effects in users.

Dangerous Interactions

"These products may interact in dangerous ways with drugs that a consumer is already taking," Hirsch says. For example, taking sildenafil in addition to certain prescription drugs containing nitrates may lower blood pressure to an unsafe level.

People with diabetes, high blood pressure, high cholesterol, or heart disease are often prescribed drugs containing nitrates, and men with these conditions commonly suffer from ED, Hirsch says. "Those are factors that doctors consider when prescribing approved ED treatments."

Preventive Measures

Levy says FDA has determined that many of these products or their active ingredients are imported into the United States from other countries.

"FDA is working closely with U.S. Customs and Border Protection to develop a more effective network to successfully screen and stop these shipments from entering U.S. commerce," says Huascar Batista, team leader of OOC's Import-Export Team.

"FDA uses all of its enforcement powers—including warning letters, seizures, injunctions, import alerts, and criminal prosecution—to protect consumers against these products," says Levy. Follow-up investigations continue to identify multiple problem products, resulting in additional import alerts, recalls, and seizure actions.

In 2008, U.S. Marshals, at FDA's request, seized products from two different firms that contained undeclared active ingredients found in FDA-approved prescription drugs for ED, or similar substances.

In April 2008, they seized more than 14,000 dosages of products known as Shangai Regular, Shangai Ultra, Super Shangai, Naturalë Super Plus, and Lady Shangai. The seized products, valued at more than $100,000, originated in China and were packaged and distributed by Shangai Distributors Inc. of Coamo, Puerto Rico.

In July 2008, the Marshals seized specific lots of illegal Xiadafil VIP tablets distributed by SEI Pharmaceuticals Inc. (SEI) of Miami, Fla. The total worth of the seized tablets neared $74,000.

In both cases, the firms prompted FDA enforcement by failing to act after being notified of the potential adverse health risks posed by the products.

FDA is also evaluating innovative ways to educate consumers about the risks of buying such sexual enhancement products and other drugs online.

Online Products to Avoid

Since 2004, FDA has identified several products sold online as so-called "dietary supplements" for treating erectile dysfunction and enhancing sexual performance. These products have contained potentially harmful, undeclared ingredients. Included among them are:


•    Actra-Rx
•    Actra-Sx
•    Libidus
•    Nasutra
•    Neophase
•    Vigor-25
•    Yilishen
•    Zimaxx
•    4EVERON
•    Liviro3
•    Lycium Barbarum L.
•    Adam Free
•    Rhino V Max
•    V.Max
•    True Man
•    Energy Max
•    HS Joy of Love
•    NaturalUp
•    Blue Steel
•    Erextra
•    Super Shangai
•    Strong Testis
•    Shangai Ultra
•    Shangai Ultra X
•    Lady Shangai
•    Shangai Regular, also marketed as Shangai Chaojimengnan
•    Hero
•    Naturalë Super Plus
•    Xiadafil VIP tablets (Lots 6K029 and 6K209-SEI only)

More health information is available online at Brain Brawn & Body. I invite you to read, learn, enjoy!

Eric Von

Publisher/Editor