By Angela Onwuzoo
The National Agency for Food and Drug Administration and Control, has confirmed that the use of Avastin injection at the National Eye Center, Kaduna conformed to quality specifications.
NAFDAC, however, cautioned health care providers in the country to ensure that use of the drug conforms with indications by the manufacturer and also warned that the drug should be utilised as registered by the agency unless there is a future scientific review of the indication for the product.
The agency in a statement said it received a complaint from a concerned Nigerian alleging that 10 patients at the National Eye Centre, Kaduna lost their eye sight following administration of Avastin 100mg injection.
According to the statement, NAFDAC management immediately initiated an investigation during which they met and discussed with the management of the National Eye Centre, Kaduna.
The agency noted that report of analysis revealed that the Avastin injection conforms to quality specifications.
The Senate had earlier urged the Federal Ministry of Health and NAFDAC to suspend further use of Avastin injection in the country pending the outcome of investigations into the incident and the
safety.
The statement stated that investigation established that the National Eye Centre, Kaduna used Avastin injection to treat patients with severe retina or macular pathologies and that the drug was administered on the 10 patients who were recalled by the Centre 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”, the statement said.
It also added: “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.”
