The FDA has issued letters to 19 medical practices in California, Illinois, and Texas that purchased unapproved cancer medicines, potentially including counterfeit bevacizumab. The label on the counterfeit version identifies the product as Avastin 400 mg/16 ml, manufactured by Roche. Swiss drug maker Roche, which owns Genentech, manufactures bevacizumab approved for marketing outside of the United States.
Genentech spokesman Terence Hurley said none of the counterfeit product was found in eye-care practices to date, but he warned ophthalmologists to check their supply. He restated the company's warning that bevacizumab is approved to treat colorectal, lung, kidney, and brain cancer—not for use in the eye. However, many retina specialists purchase it from compounding pharmacies that break down the large vials into single-unit doses because it works similarly to ranibizumab (Lucentis, Genentech) but costs much less.
The counterfeit products carry labels with batch numbers that start with B6010, B6011, or B86017, the FDA said. The FDA-approved version of the drug does not include the Roche logo on the packaging or vials. The FDA-approved drug also contains a 6-digit batch number and expiration dates in a 3-letter month and 4-digit year format, the date of manufacture is not printed on the carton or vial, and all of the text on vial labels, cartons, and package inserts is in English.
The 19 practices purchased unapproved cancer medicines and, potentially, the counterfeit bevacizumab from Quality Specialty Products (QSP), a foreign supplier also known as Montana Health Care Solutions, which once listed its administrative offices in Belgrade, MT. Volunteer Distribution, in Gainesboro, TN, is a QSP distributor.
Chemical analyses of the counterfeit products show they do not contain bevacizumab, Avastin's active ingredient.
"FDA has requested that the medical practices stop using any remaining products from these suppliers," the agency wrote in its Feb. 14 statement.
American Academy of Ophthalmology spokesman Kevin Walter said members were advised of the FDA report and informed how to identify the counterfeit drug.
"We told our members that they may wish to contact their compounding pharmacy to confirm the authenticity of its Avastin supply," he said.
Roche and Genentech said the companies are working with the FDA and law enforcement to prevent further distribution of the counterfeit product.
In 2010, 116 patients in Shanghai received injections of a counterfeit version of bevacizumab, and some suffered complications, according to The Wall Street Journal. Roche told Reuters that a counterfeit version of the product was found in Syria in 2009, and the company warned physicians after bacterial contamination was discovered in the fake product.
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