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Another Counterfeit Drug Product Places Cancer Patients in US at Risk, FDA Warns
Another counterfeit version of a cancer drug has been found in United States medical practices, placing patients at risk, Food and Drug Administration (FDA) warns. The counterfeit version of Roche’s Altuzan® 400 mg/16 ml (bevacizumab), an injectable cancer medication, originated from a foreign source and FDA lab tests have confirmed that it contains no active ingredient. FDA specifies that packaging and vials found in the US that claim to be Roche’s Altuzan with lot number B6021 should be considered counterfeit. Images of the counterfeit product are included in an FDA news release. Further, FDA indicates that even if the identified drugs were not counterfeit, Altuzan is not approved by FDA for use in the US; it is an approved drug in Turkey. Medical practices obtained the counterfeit Altuzan and other unapproved products through foreign sources, in particular from Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc. Many, if not all, of the products sold and distributed through this distributor have not been approved by FDA. On February 14, 2012, FDA issued an alert about a counterfeit version of Avastin® 400 mg/16 mL in US distribution that was purchased from a foreign source.
FDA stresses that when medical practices purchase and administer illegal and unapproved foreign medications, they place patients at risk of exposure to drugs that may be fake, contaminated, improperly stored and transported, ineffective, and dangerous. In addition, using unapproved drugs deprives patients of proper treatment. Any medical practice that has obtained unapproved products, in particular from Richards Pharma, Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc, should stop using them and contact FDA. The products should be retained and securely stored until further notice by FDA.
FDA asks the public to report suspect counterfeit products and other suspect products obtained from Richards Pharma, Richards Services, Warwick Healthcare Solutions, Ban Dune Marketing Inc, or other sources by calling the FDA’s Office of Criminal Investigations (OCI) at 800/551-3989, or by submitting a report using the online form on OCI’s Web site. Health care providers and patients are also encouraged to report adverse events related to the use of suspect injectable cancer medicines to FDA’s MedWatch Safety Information and Adverse Event Reporting Program using the online form. Instructions for submitting a report by mail are included in the FDA news release.
