The United States Food and Drug Administration (USFDA) has advised that it has found instances of medical clinics in the United States importing a counterfeit version of the injectable drug bevacizumab (brand name Avastin). The counterfeit version did not contain the active ingredient as was claimed and may have resulted in patients not receiving their needed therapy.
The counterfeit product was made available in 400mg/16ml vials. The counterfeit product in the USA is said to have included French and Arabic lettering on the packaging and had batch numbers that start with B6010, B6011 or B86017.
The Therapeutic Goods Administration (TGA) has not received any reports to date of similar counterfeit Avastin vials being found in Australia.
About Avastin
Avastin is approved in Australia for use in the treatment of a number of cancers including metastatic bowel cancer, some breast cancers, non-small cell lung cancer, some cancers of the kidney and some brain cancers.
400mg/16 ml vials are one of the two registered presentations of Avastin in Australia.
Information for healthcare professionals
Healthcare professionals are reminded that the Therapeutic Goods Act provides for very severe penalties, including imprisonment, for the importation or supply of counterfeit medicines in Australia.
The TGA has sent information on counterfeit Avastin to hospital and community pharmacies.
Report counterfeit medicines and medical devices
If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:
- online: Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products
- in writing, via post to:
Chief Investigator
Regulatory Compliance Unit
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606 - telephone: 1800 020 653.