Night Bullet: Recall - Undeclared Drug Ingredient

ISSUE: Green Planet, Inc. notified the public of a recall of its dietary supplement product Night Bullet. Analytical tests conducted by the FDA found that the product contains trace amounts of Sulfohydroxyhomosildenafil and Aminotadalafil, which are analogues of sildenafil. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED), making this product an unapproved drug.

The following product lot is being recalled: B43N032, UPC code 018505122233, Expiration Date 10/2015. These undeclared active ingredients pose a threat to consumers because sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and 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. Sildenafil may also cause side effects such as headaches and flushing.

Does Circumcision Affect Pleasure?

Circumcision does not affect performance or satisfaction as noted in various studies. 

The overall prevalence of circumcision [In the USA] was 79% and varied by race/ethnicity:

88% in non-Hispanic whites

73% in non-Hispanic blacks

42% in Mexican Americans

50% in all others

Review article in the journal AIDS in 2000 showed a reduced risk of HIV infection of 44% among circumcised men as compared to uncircumcised men.

Caution about Sexual Enhancement Products

FDA Consumer Corner

You can easily find them on the internet - products sold as "dietary supplements" to enhance sexual performance or treat erectile dysfunction. Many of these products are said to be "all natural" alternatives to prescription drugs. That might make you think they're harmless. But they may not be.


FDA has found that many of these supposedly "all natural" products actually contain ingredients that aren't on the label, and these ingredients could lead to serious and even fatal effects.


An FDA investigation of a number of these sexual enhancement supplements found that a third of them actually contained the same or similar ingredients to the class of prescription drugs that includes Viagra (sildenafil citrate), Cialis (tadalafil) and Levitra (vardenafil HCl.

Hidden Risks of Erectile Dysfunction "Treatments" Sold Online

 

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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).

Ginseng + Saffron = Good Sex? Aphrodisiacs Found in Common Spices

By BONNIE ROCHMAN |

 
Improving sexual function and desire is a pretty lucrative, albeit pricey, industry. But what if spicing up your love life were a lot cheaper and as simple as opening up your kitchen cabinet or heading to a health-foods store?

New research recently published online in the journal Food Research International finds that ginseng and saffron are key to spicing up your sex life. Both boost sexual performance, according to a scientific review of natural aphrodisiacs done by researchers at the University of Guelph in Ontario, Canada. (More on Time.com: Many Men and Women Say They Aren’t Getting Enough Sex)