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FDA Notifications and Warnings
Following the Food and Drug Administration (FDA) determination that propoxyphene may cause serious or even fatal heart rhythm abnormalities, Xanodyne Pharmaceuticals Inc has agreed to withdraw the brand versions of the drug, Darvon® and Darvocet®, from the United States market. FDA has also requested that manufacturers of generic propoxyphene-containing products withdraw these products from the market. FDA advises health care providers to stop prescribing propoxyphene and advises patients to contact their health care providers as soon as possible to discuss alternative pain management therapy. Additional information on the FDA decision is available in an FDA news release.
In addition, FDA warns health care providers and consumers that Vigor-25, a product marketed as a natural dietary supplement to enhance male sexual performance, contains sildenafil and should not be purchased or used. Sildenafil, the active ingredient in the prescription drug Viagra®, may interact with prescription drugs known as nitrates, including nitroglycerin, and can dangerously lower blood pressure. Vigor-25 is sold on Internet sites and possibly in some retail outlets. FDA advises consumers who have experienced any negative side effects from sexual enhancement products to stop using the product and consult their health care provider. FDA urges health care providers and consumers to report adverse events or side effects from use of Vigor-25 to the FDA’s MedWatch Adverse Event Reporting program by visiting the FDA Web site. More information about this warning is available in an FDA news release.
FDA also seeks information regarding Bristol-Myers Squibb (BMS) prescription drug products stolen in Florence, KY while in transport on November 10, 2010. Drugs stolen include Abilify®, Avalide®, Avapro®, and Coumadin® and the lot numbers in question are designated solely for the Canadian market, are in complete batches, and have not been distributed previously in any market. A list of lot numbers for the stolen products is available on the FDA Web site. FDA reminds pharmacists and other health care providers that drug product should not be used if it has been removed from the sealed bottle or container, if the induction seal has been compromised, or, in the case of Abilify blister packs, if the foil appears to have been disturbed in any way. Further, information regarding this incident or suspicious or unsolicited offers for the specified BMS products should be reported to the FDA Office of Criminal Investigations (OCI) by calling 800/551-3989 or by visiting the OCI Web Site.
