FDA is alerting health care providers that an unapproved cancer medicine distributed by a United States company, Medical Device King (also known as Pharmalogical), is counterfeit. FDA reports that at least one batch of a counterfeit version of Roche’s Altuzan distributed in the US contains no active ingredient. The agency notes further that even if the identified product were not counterfeit, Altuzan (bevacizumab), an injectable cancer medicine, is not approved by FDA for sale in the US. The only FDA-approved version of bevacizumab for sale in the US is called Avastin®, marketed by Genentech. The product labeled as Altuzan (bevacizumab) 400 mg/16 mL may be counterfeit if it displays batch No. B6022B01 (expiration date 11/2013) or batch No. B6024B01 (expiration date 02/2013).
FDA advises that medical practices that have obtained any medical products from Medical Device King, Pharmalogical, and Taranis Medical (another company associated with Pharmalogical) should stop using the products due to concern that the products may be unsafe or not effective. Health care providers should contact FDA’s Office of Criminal Investigations to arrange for the collection of these products. “Medical practices that purchase and administer unapproved medicines are putting patients at risk of exposure to medicines that may be counterfeit, contaminated, or improperly stored and transported,” warns FDA. To protect patient health, health care providers should use only FDA-approved medicines. Additional details and tips for minimizing the chance that patients are exposed to counterfeit medications are available in an FDA alert. FDA issued alerts about counterfeit cancer medications in February 2012 and April 2012.
FDA advises that health care providers should purchase prescription drugs either directly from the manufacturer or from wholesale drug distributors licensed in the US and provides a list of state agencies for assistance in verifying licensure. Another way that pharmacies can be assured of the legitimacy of a wholesale distributor is to look for NABP’s Verified-Accredited Wholesale Distributors®(VAWD®) Seal. Those wholesale distributors that achieve VAWD accreditation are in compliance with state and federal laws and NABP’s VAWD criteria. Wholesale distributers that display the VAWD Seal as part of their accreditation have undergone a criteria compliance review, including a rigorous review of their operating policies and procedures, licensure verification, survey of facility and operations, background checks, and screening through the NABP Clearinghouse. Accredited facilities are reviewed annually and undergo a site survey every three years. Created in 2004, the accreditation program plays a pivotal role in preventing counterfeit drugs from entering the US drug supply.