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Recently, ten (10) patients at the National Eye Centre, Kaduna lost their eye sight following administration of Avastin 100mg injection, an injection actually meant for cancer treatment. This decision has now been found wanting by the National Agency for Food and Drug Administration and Control (NAFDAC).
The said Avastin injection according to NAFDAC, was registered in Nigeria for 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,” said NAFDAC in a statement sent to BusinessDay, “that is, it is not indicated on the label by the manufacturer or approved for treatment of eye ailments by NAFDAC.”
The statement further noted that 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.
However, the product, as evidenced by the usage in Kaduna, appears to be wrongfully administered on patients, for purposes other than what it is labelled for.
The NAFDAC statement follows an investigation after a report of the incident was made, and circulated in the media. According to NAFDAC, a team was constituted to investigate the situation, and members of the team met with the Management of the National Eye Centre, Kaduna. One packet of Avastin injection in stock at the hospital was taken for laboratory analysis to ascertain the quality of the product, and the report of analysis revealed that the Avastin injection conforms to quality specifications.
The Avastin 100mg injection was administered on the ten (10) patients at National Eye Centre, Kaduna, for treatment of severe retina or macular pathologies, according to NAFDAC’s investigation. However, all of ten known patients who received this injection reportedly became totally blind the same day they received injections.
NAFDAC reiterated that Health care providers are implored 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.