The U.S. Food and Drug Administration has confirmed that a counterfeit version of the cancer treatment Avastin 400 mg/16mL is on the market in the United States. The drug, the FDA says, may have been purchased and used by some U.S. medical practices.
Avastin is an injectable medication, administered to patients in clinics, hospitals and doctors’ offices for the treatment of cancer. The counterfeit version does not contain the the active ingredient of Avastin, bevacizumab. This may result in patients not receiving their needed therapy, the FDA is warning.
The FDA has issued letters to 19 medical practices in the U.S. known to have purchased unapproved cancer medications that may include the counterfeit Avastin. The counterfeit version, the FDA says, is labeled as Avastin, manufactured by Roche. However, Roche is the company that manufactures Avastin approved for marketing outside of the United States, the FDA explains.
Roche has tested the drugs, and has confirmed that they are counterfeit. Indications of counterfeit packages or vials include:
- The drugs are labeled with Roche as the manufacturer
- The display batch numbers start with B6010, B6011 or B86017
- The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). The FDA-approved version does not include the Roche logo on the packaging or vials. In addition, Genentech’s FDA-approved version of Avastin vials and packaging have a 6-digit numeric batch number and expiration dates in a 3-letter month and 4-digit year format (e.g., JAN 2014).
Genentech’s Avastin products are safe and effective for their intended uses.
The 19 medical practices in the United States purchased unapproved cancer medicines and, potentially, the counterfeit Avastin, from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, TN, is a distributor of QSP’s products. The FDA has requested that the medical practices stop using any remaining products from these suppliers. FDA cannot ensure the safety or efficacy of any of these unapproved products.
Based on information to date, The FDA has determined that none of the unapproved cancer medicines received by these medical practices from Volunteer Distribution are in shortage in the United States. FDA-approved versions of these medicines are available in adequate supply to meet current demand.
Medical practices that have obtained unapproved products from foreign sources, in particular from Volunteer Distribution and/or QSP, should stop using them and contact the FDA. These products should be retained and securely stored.
To report suspect counterfeit products and other suspect unapproved products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions or other sources:
- Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989, or
- Visit OCI’s Web site (www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm2), or
- Email - DrugSupplyChainIntegrity@fda.hhs.gov.
Health care professionals and consumers are asked to report adverse events related to the use of suspect injectable cancer medicines to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail, by fax, or by phone. Health care professionals and consumers can either:
- Complete and submit the report online: www.fda.gov/MedWatch/report.htm3, or
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Genentech has released a statement regarding the counterfeit Avastin, confirming that it has been distributed in the United States:
“The counterfeit product is not safe or effective and should not be used. Chemical analyses of the counterfeit vials tested to date have confirmed the product does not contain the active ingredients for Avastin.
“Patient safety is Roche and Genentech's primary concern. We are working with the U.S. Food and Drug Administration (FDA) and law enforcement to aid their evaluations, determine the source of the counterfeit drug, and prevent its further distribution.”
Genentech also confirmed that the lot numbers on the vials/packaging of the fake Avastin, labeled as Avastin 400 mg/16mL, are believed to include the following:
The counterfeit product does not look similar to authentic Avastin that is FDA-approved for the treatment of certain cancers in the United States, Genentech says (see photo above, and see the Genentech statement for additional product photos). Additionally, the following is true for all authentic Avastin that is FDA-approved for use in the United States, Genentech confirms:
•All cartons and vials approved for use in the United States have "Genentech" or "Genentech, a member of the Roche Group" printed on the labels;
•The lot number on the carton and vial should be 6 digits with no letters;
•The expiry date is formatted as a 3-letter month and 4-digit year, e.g. JUL 2014;
•The date of manufacture is not printed on the carton or vial;
•All the text on the vial labels, cartons and package inserts is English.
“Counterfeit medicines are mostly offered for sale by unlicensed sources,” Genentech says. “In order to help ensure the integrity of the supply chain for Genentech's medicines in the United States, our medicines are sold directly to a defined number of licensed wholesalers and specialty distributors.”