Nigeria’s drug control agency, NAFDAC, has said that the Avastin 100mg injection, that allegedly led to the blindness of 10 patients at the National Eye Centre, Kaduna was wrongly administered.
Avastin was licensed in Nigeria for cancer-related diseases and their use at the eye center, according to a report released on its official website on Sunday “was an off-label use”.
Avastin is a drug that is used to treat age-related macular degeneration (AMD). It is also used to treat diabetic eye disease and other retina issues.
It is injected into the eye to assist slow the loss of vision from these illnesses.
Earlier, the Nigerian Senate had advised the health authority to “suspend forthwith” the country’s use of Avastine injections.
The call for suspension was raised after 10 people went blind after the drug was allegedly administered to them.
The health agency said it received a complaint about the incident from a ‘ concerned Nigerian ‘ on Monday, June 3, 2019 and instantly launched an inquiry.
It said officials then met and talked to the center’s management.
It also said the hospital took a packet of Avastin injection for laboratory evaluation to determine the product’s quality.
However, the report said an assessment revealed that the injection of Avastin is consistent with quality requirements.
“The 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.”
NAFDAC also implored health care providers to ensure the 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”.