Another “dietary supplement” for sexual enhancement has failed to stand up to Food and Drug Administration (“FDA”) examination. Manufacturer RockHard Laboratories promotes its “RockHard Weekend” product as “a 100% all-natural formula from a tried and tested unique blend of 13 herbal ingredients that work together to give 72 hours of Sexcitement.™” The product is claimed to be “Naturally Safe,” Doctor Tested,” and “Doctor Approved.”
One thing that RockHard Weekend is not, however, is approved by the FDA. Why does it need FDA approval? An FDA notice released this week warns that the product “contains sulfoaildenafil, an analogue of sildenafil, an FDA-approved drug used as treatment for Erectile Dysfunction (“ED”). The presence of sulfoaildenafil makes RockHard Weekend an unapproved drug. This undeclared drug ingredient may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure.” Sildenafil is the active ingredient in Viagra.
Sulfoaildenafil is not listed on the RockHard Weekend label, putting some consumers who might not otherwise use the product at risk. The undeclared ingredient may pose a threat to consumers because it may interact with nitrates found in nitroglycerin and other prescription drugs. It may also 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 some may seek these types of products to enhance sexual performance.
The recalled product is sold nationwide in single blisters and 3-count and 8-count bottles. The following lot numbers are included in the recall:
- Blister Pack: T12 705 08 (exp: 10/11) / T12 705 09 (exp: 3/12, 8/12)
- 3ct Bottle: R417 0509 (exp: 09/12)
- 8ct Bottle: T237-0509 (exp: 06/12)
RockHard Weekend joins other brands of dietary supplements marketed as enhancing sexual performance to be recalled for containing undeclared drug ingredients. Over the past several years, the FDA has found more than thirty products marketed as so-called “dietary supplements” for treating ED and enhancing sexual performance that contain undeclared active ingredients of FDA-approved drugs, analogs of approved drugs and other compounds that do not qualify as “dietary ingredients.” Marketing drugs without proper disclosure is illegal, and the FDA has issued multiple alerts about these contaminated dietary supplements.
Consumers and health care professionals should be aware of this problem and the health hazard it presents. Sexual enhancement products that claim to work as well as prescription products are likely to contain a contaminant. Use of such products exposes consumers to unpredictable risk and the potential for injury or even death. Because they are labeled using descriptions such as “all natural dietary supplement,” however, consumers may assume they are harmless and pose no health risk.”
If you or a loved one sustain serious injury due to life-threatening side effects after taking a “dietary supplement,” please contact Portland, Oregon prescription drug attorney and personal injury lawyer Dane Johnson online or call us toll free at (800) 714-3204. The Law Office of Dane E. Johnson is currently investigating injuries related to products containing undisclosed drugs. We offer a free case evaluation.
Related Web Resources
Press Release, FDA, RockHard Laboratories Issues a Voluntary Nationwide Recall of Specific Lots of RockHard Weekend Marketed as Dietary Supplement (Nov. 9, 2009).
FDA, Hidden Risks of Erectile Dysfunction “Treatments” Sold Online (2009).
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