Tag: Dietary supplement

X-Hero and Male Enhancer (When supplements “work X)

Shockingly, two “dietary supplements” for male enhancement have been found to contain active ingredients that happen to treat erectile dysfunction. Effectively, these products are unannounced and unregulated versions of Viagra (X-Hero) and Cialis (Male Enhancer), both of which have risks of negative interactions with other drugs. These interactions can only be avoided if individuals are aware that they are being exposed.

FDA lab analysis of X-Hero found the product contains sulfosildenafil, the analogue of the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED), making X-Hero an unapproved drug. In addition, FDA analysis of Male Enhancer sample found the product contains tadalafil, the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED), making Male Enhancer an unapproved drug.

The products pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance.

–FDA Medwatch (emphasis added)

Soladek: Too much of a good thing (When supplements “work” IX)

No undeclared ingredients here, just dangerous levels of Vitamins A & D in an effectively unregulated dietary supplement called Soladek Vitamin Solution.

ISSUE: Tested samples of Soladek contained levels of vitamin A and vitamin D that were many times the recommended daily allowances for these vitamins. . .Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects. Symptoms of vitamin D toxicity include weakness, fatigue, headache, nausea, vomiting, diarrhea, changes in mental status, increased blood pressure, abnormal heart rate or rhythm, kidney damage, and coma.

–FDA Medwatch

For vitamins, like many biochemically active compounds, more is not better. Rather, the body wants the right amount. Many vitamins are water soluble and very difficult to overdose on, as you simply eliminate the excess in your urine. Vitamins A & D are fat soluble and not so easily removed.

Usually, these cases have not been associated with reports of health problems. Not so in this case.

The FDA received seven reports of serious health problems occurring in consumers using the product. The problems include decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea.

-FDA Medwatch