Do Not Use Vigor-25
The U.S. Food and Drug Administration says Vigor-25, a product marketed as a natural dietary supplement to enhance male sexual performance, should not be purchased or used because it contains sildenafil, the active ingredient in the prescription drug Viagra.
Sildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and can dangerously lower blood pressure. The FDA is investigating the reported death of a 26-year old man, possibly associated with the use of Vigor-25.
Vigor-25, distributed by Piston Corp., is sold on Internet sites and possibly in some retail outlets.
"This product is dangerous to consumers because it claims to contain only natural ingredients when it actually contains a prescription drug ingredient," said Deborah M. Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "Tainted products place consumers at risk of injury and death, especially those consumers with underlying health conditions."
The FDA has found many products marketed as dietary supplements for sexual enhancement during the past several years that can be harmful because they contain active ingredients in FDA-approved drugs or variations of these ingredients. Sexual enhancement products promising rapid effects (e.g., claim to work in minutes to hours) or long-lasting effects (e.g., claim to last 24-72 hours) are likely to contain a contaminant.
The FDA advises consumers who have experienced any negative side effects from sexual enhancement products to stop using such products and consult a health care professional and to safely discard the product. [Editor's note: followup conversations with the FDA suggest that if you can safely save the product for evidence, please do so.] The FDA urges health care professionals and consumers to report adverse events or side effects from use of Vigor-25 to the FDA's MedWatch Adverse Event Reporting program either by completing and submitting the report online, downloading the form or calling 800-332-1088 to request a reporting form, then completing and returning to the address on the pre-addressed form or submitting by fax to 800-FDA-0178.
Consumers also are urged to report suspected criminal activity regarding sexual enhancement products, including Vigor-25, to the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by reporting it on the OCI website at www.fda.gov/oci.
Notification of Stolen Bristol-Myers Squibb Products
Bristol-Myers Squibb (BMS) is working with the U.S. Food and Drug Administration's Office of Criminal Investigations (FDA), and other law enforcement officials, to recover cases of specified lots of recently stolen pharmaceutical products. The specified lots were being transported in a tractor-trailer stolen in Florence, Kentucky, on Interstate 75 North at around 10 p.m. on Wednesday, November 10, 2010. The trailer contained the products, lots and quantities listed below.
Anyone who has information regarding this incident or has received suspicious or unsolicited offers for the specified BMS products after the date of the theft is encouraged to contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations at 1-800-551-3989 or by visiting the OCI Web Site.
For medical inquiries about this matter, contact BMS at 1-800-321-1335; for general inquiries, call 1-800-332-2056.
Description and Lot of Stolen Products:
Abilify 10mg tablets 30's 0H53513C
Abilify 10mg tablets 7's SAMPLE 0H53513
Avalide 150/12.5mg tablets 90's 0F59141A
Avalide 300/12.5mg tablets 90's 0E62462A
Avalide 300/12.5mg tablets 90's 0E62463A
Avapro 150mg tablets 90's 0J61465A
Coumadin 3mg tablets 100's 0H51118B
Plavix 75mg tablets 500's 0A059A
Reyataz 300mg capsules 30's 0K5011A
For More Information see the FDA Alert.
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Contact
FDA's Office of Criminal Investigations (OCI)
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About the SafeMeds Alert System
As part of the FDA's Alert Network, the SafeMeds Alert System is a free service that sends official alerts from the FDA and other government agencies around the world to anyone-private citizens, public groups, corporations, associations-when specific counterfeit drug incidents occur.
The SafeMeds Alert System is a service of the Partnership for Safe Medicines-a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. For more information, please visit SafeMedicines.org. | |
