The FDA has announced a voluntary recall of the “sexual health” (ie, erectile dysfunction) dietary supplement ACTRA-Sx 500 due to “adulteration” with the active compound from Viagra, sildenafil citrate. This is yet another recall of a “dietary supplement” that happens to be adulterated with a pharmaceutical that has been proven to treat the condition the supplement claims to address. This might make the supplement “work”, but it poses a real hazard to customers who are not permitted to know what they are taking. Continue reading
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)
Normally, when we learn that alternative medicine substances are contaminated with actual, scientifically tested pharmaceuticals that happen to do the exact same thing the “all-natural” supplement purports to do (oops), we can happily report these issues are not associated with serious injury or death. Normally. Sometimes people do get hurt:
FDA has received multiple reports of adverse events associated with the use of Fruta Planta, including several cardiac events and one death. FDA laboratory analysis confirmed that Fruta Planta contains sibutramine, a controlled substance that was withdrawn from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Fruta Planta may also interact in life threatening ways with other medications a consumer may be taking.
- FDA Medwatch – “Fruta Planta: Public Notification – Undeclared Drug Ingredient” – 23 December 2010 (emphasis mine) Continue reading