…Ophthalmologists caution against ban

By Sola Ogundipe

Following a public complaint that 10 patients at the National Eye Centre, Kaduna, allegedly lost their eyesight following administration of Avastin 100mg injection, the National Agency for Food and Drug Administration and Control, NAFDAC, has said the use of the drug conforms to quality specifications.

Avastin injection

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.

Meanwhile the Ophthalmologists Society of Nigeria has cautioned against banning of Avastin in the country, saying ith move could inadvertently lead to several patients going blind.

In a statement made available to Vanguard, the NAFDAC management said on Monday, June 3, 2019, said it received a complaint from a concerned Nigerian about the incident and immediately initiated an investigation during which the Agency met and discussed with the management of the National Eye Centre, Kaduna.

The statement noted 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.”

Further, the statement said: “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,” the statement observed.

The NAFDAC 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.

Responding to the development, the Ophthalmologists Society of Nigeria, OSN, called for adherence to global standard practice concerning Avastin intraocular injection even as it cautioned against the proposed ban by the Senate saying the move would be counterproductive.

The National President and General Secretary of the Society, Dr .Ayobade Ogundipe and Dr Yinka Ologunsua respectively, called for the adherence to a globally established protocol before such ban is effected.

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And In a signed statement, the duo noted that members of the Society’s Vitreoretinal Subspecialty group have been using Avastin for several years with documented safety and efficacy among Nigerians and that its ban may inadvertently make several patients go blind.

“Several patients especially those with (diabetes, hypertension, age related macular degeneration) sometimes develop retinal complications requiring treatment. Avastin remains the most affordable of all drugs in use. There is need for more scrutiny and diligence from all stakeholders, uncompromised quality assurance and best practice from end users,” the Society argued.

According to the American Academy of Ophthalmology, Avastin is the brand name for a drug called bevacizumab and is used to treat wet age-macular degeneration, AMD, as well as diabetic eye disease and other problems of the retina.

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When blood vessels at the back of the eye begin to leak, vision is affected leading to vision loss from wet AMD and diabetic eye disease and Avastin is injected into the eye to help slow vision loss from these diseases.

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