NAFDAC’s Response to Avastin Injection Complaint

Water for Injection

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a statement stating that on Monday, June 3, 2019, the agency received a complaint from a concerned Nigerian that ten (10) patients at the National Eye Centre, Kaduna lost their eye sight following administration of Avastin 100mg injection.

NAFDAC states that in response to the complaint, an investigation was immediately initiated. The members of the team met and discussed with the Management of the National Eye Centre, Kaduna on June 3, 2019. The following facts were established:

  • Avastin 100mg injection was administered on the ten (10) patients at National Eye Centre, Kaduna.
  • National Eye Centre, Kaduna used Avastin Injection to treat patients with severe retina or macular pathologies.
  • The ten (10) patients were recalled by National Eye Centre, Kaduna for observation and management following their complaints.
  • The indications for which NAFDAC registered Avastin injection are metastatic colorectal cancer, metastatic breast cancer, advanced metastatic or recurrent non-small cell lung cancer, advanced and/ or metastatic renal cell cancer, ovarian cancer and cervical cancer.
  • Therefore, the use of Avastin injection at the National Eye Center was an off-label use, i.e., it is not indicated on the label by the manufacturer or approved for treatment of eye ailments by NAFDAC
  • Avastin 100mg injection manufactured by F. Hoffmann-La Roche, Kaiseraugst 4303 Switzerland is registered by NAFDAC with NAFDAC Registration Number A6-0123. Avastin 400mg injection manufactured by F. Hoffman-La Roche, Mannheim, Germany is also registered with NAFDAC Registration Number A6-0101.

One packet of Avastin injection in stock at the hospital was taken for laboratory analysis to ascertain the quality of the product.  The report of analysis revealed that the Avastin injection conforms to quality specifications.

NAFDAC is therefore imploring health care providers to ensure that Avastin injection is used as indicated by the company and as registered by the agency unless there is a future scientific review of the indication for the product.

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About Ufuoma Akpotaire 258 Articles
Ufuoma is a Senior Editor and Director of Regulatory Policy at NLIPW. She assists clients in the protection of copyrights, trademarks and patents. She counsels clients regarding validity and infringement matters and has experience acting against the infringement of IP and addressing counterfeit issues. She holds a Masters degree (LL.M.) from Columbia Law School, New York and a law degree from the University of Nigeria (LL.B. Honors). She is admitted to practice law in Nigeria and in the State of New York. Ufuoma cut her teeth in the intellectual property practice groups of some of the largest law firms in Nigeria and has years of experience working with major non-profit organizations in New York. Email: uakpotaire@nlipw.com

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