Ophthalmological Society of Nigeria (OSN) has reacted to a call by the National Assembly to ban the use of Avastin intraocular injection in Nigeria on the premise that it is meant for the treatment of cancer.
The decision of the Senate came as a result of a motion moved by Senator Aishatu Dahiru and seven others on the claim that 10 patients went blind after the administration of the injection at the National Eye Centre (NEC).
Senator Dahiru claimed that her investigation confirmed those made blind by the Russian made Avastin injection were still under the care of the hospital as of July 2, 2019 (33 days after the incident) with little or no improvement.
The association in a release signed by its president, Dr Ayobade Ogundipe and secretary general, Dr Yinka Ologunsua, stated that the drug initially approved for cancer treatment in 2006 also received FDA off label approval two years after for the treatment of macular degeneration.
According to them, “the new macular degeneration drug was celebrated as a major medical breakthrough. Off label use of medications in medicine is often allowed in peculiar cases and does not indicate any form of malpractice. It is still in use all over the world and is on the WHO model list of essential eye preparation.
“It has been used safely in several patients globally and in Nigeria with reported visual improvement. However, Avastin, like any other drug, has its documented contraindications, possible reactions and complications.
“Numerous trials on thousands of patients worldwide have shown Avastin injection in the eye to be non-inferior to other approved similar products such as Lucentis (Ranibizumab) in terms of efficacy and safety. Avastin, however, has the advantage of reducing the cost of therapy hence its dominant use over others in its group.”
OSN said it had been in touch with the NEC Kaduna to ascertain the facts of this incidence and assured that some of the patients have regained vision better than the before the injections were applied to their eyes and all are still being monitored at the National Eye Centre and at no cost to them.
They said that incidences of drug contaminations are not unusual from the point of manufacture to end users, adding “there are established protocols that should be followed to audit each incident. The NEC Kaduna commenced this process immediately, which included informing the regulatory agency (NAFDAC).
“We appreciate the Senate for the steps taken so far and would be willing to collaborate with her in every step taken to resolve the present situation and forestall any future occurrence.
“Several patients, especially those with diabetes, hypertension, age-related macular degeneration sometimes develop retinal complications requiring treatment. Avastin TM remain the most affordable of all drugs in use.
“While we await the report from NAFDAC, we call for more scrutiny and diligence from all stakeholders, uncompromised quality assurance and best practice from the end users.
“We expect adherence to a globally established protocol before a ban is effected. Members of the Ophthalmological Society of Nigeria who have been using this drug for several years have documented the safety and efficacy of AVASTINTM use among Nigerians. Its ban may inadvertently make several patients go blind.”