This time, the 400 mg/16 ml vials are marked Altuzan, the trade name for bevacizumab approved for use in Turkey, and have a lot number B6021. The vials were purchased through foreign sources, including Richards Pharma, alternately known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc.
The FDA has warned 58 oncology practices in 12 states that they should immediately discontinue use of the drug products, including the counterfeit bevacizumab.
While the FDA has not approved bevacizumab, a cancer drug, for use in the eye, many U.S. retina specialists use the drug off-label in the treatment of age-related macular degeneration because it often is as effective as its more-expensive, FDA-approved cousin, ranibizumab (Lucentis, Roche/Genentech).
"Although at present ophthalmology clinics have not been alerted, FDA urges the healthcare community to examine their purchasing practices to ensure that they buy directly from the manufacturer or from licensed wholesale drug distributors in the United States," FDA spokeswoman Lisa Kubaska said.
"FDA reminds healthcare professionals, pharmacies, and wholesalers/distributors that they are valuable partners in protecting consumers from the threat of unsafe or ineffective products that may be stolen, counterfeit, contaminated, or improperly stored and transported. The receipt of suspicious or unsolicited offers from unknown suppliers should be questioned, and extra caution should be taken when considering such offers."
Genentench spokesman Terence Hurley referred questions to the FDA.
In February, the FDA warned that counterfeit versions of bevacizumab, labeled as Avastin with Roche as the manufacturer, were circulating in U.S. medical practices. In that case, 19 oncology practices were warned to stop using the drugs they purchased from Quality Specialty Products, also known as Montana Health Care Solutions, and distributed by Volunteer Distribution in Gainesboro, TN. Those versions also did not contain the active ingredient.
Kubaska said the counterfeit products were found as part of the agency's ongoing investigations targeting criminal enterprises involved in drug counterfeiting activities.
In circumstances in which FDA-approved drugs are in short supply, the agency will authorize certain, limited importation of medicines. However, they are obtained from approved international sources and distributed through a controlled network, and would not be sold in direct-to-clinic solicitations, the FDA said. Bevacizumab is not in short supply.