ISSUE: FDA notified consumers that lab analysis of lots of ejaculoid XXTREME and stimuloid II found that the products, sold as dietary supplements, contain sulfoaildenafil, similar to sildenafil, which is an active ingredient of an FDA-approved drug for male erectile dysfunction, making these products unapproved drugs. This active drug ingredient is not listed on the product labels and may interact with nitrates found in 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.
BACKGROUND: The recalled products were distributed in black plastic bottles to distributors and via internet sales. The company press release contains specific lot numbers and additional recall information.
RECOMMENDATION: Customers who have any of the above products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking these products.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Online: www.fda.gov/MedWatch/report.htm
- Phone: 1-800-332-1088
- Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
- Fax: 1-800-FDA-0178
[07/28/2010 - Press Release - Nutraloid Labs Inc]
[07/28/2010 - Nutraloid Product Photos - FDA]