"When you’re an oncologist administering these kinds of drugs, you just can’t take that chance. You want to make sure that what you give the patient is exactly the drug and exactly the dosage."
In its first fake-bevacizumab warning, the FDA said that 19 U.S. medical practices obtained the counterfeit from Quality Specialty Products (QSP), a foreign supplier also known as Montana Health Care Solutions. QSP products are also distributed by Volunteer Distribution in Gainesboro, Tenn.
The agency specified medications purchased from a foreign distributor named Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc. (BDMI) in its more recent letter alerting oncologists to the second counterfeit.
"Packaging or vials found in the [United States] that claim to be Roche’s Altuzan with lot number B6021 should be considered counterfeit," the agency wrote. The counterfeit version of Altuzan contains "no active ingredient."
Other drugs already obtained from these sources are also suspect, according to the letter. "Many, if not all, of the products sold and distributed through this distributor have not been approved by the FDA," the agency said.
What the FDA Wants Physicians to Do
The FDA advised physicians to stop using these products and to contact the FDA. The products should be retained and securely stored until further notice by the FDA. The agency recommends that physicians take the following actions:
• Report adverse events related to the use of suspect injectable cancer medicines to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
• Verify that a supplier is licensed in a particular state by going to the Drug Integrity and Supply Chain Security section of www.fda.gov for a list of state websites and contacts where this information can be found.
• Report suspected counterfeit products to the FDA Office of Criminal Investigations (OCI) at 800-551-3989, or by e-mail to DrugSupplyChainIntegrity@fda.hhs.gov.
Dr. Bloche and Dr. Cobb said they have no relevant conflicts of interest.