Nigerian Senate on Wednesday in its plenary session passed a motion mandating National Agency for Food and Drug Administration and Control (NAFDAC) to suspend importation and usage of Avastin henceforth. Avastin is a drug used in the treatment of various eye-blinding conditions. The decision was taken following an unfortunate incidence that happened few weeks ago at National Eye Centre Kaduna where some patients developed complications that led to loss of their sight (albeit some regained their vision) after administration of the injection. I must to commend the senate under the able leadership of Senate President, Senator Ahmad Lawan, for taking interest in the plight of the victims and in bringing the issue to the limelight, however I have few observations to make on the resolutions taken on the floor of the hallowed chamber.
The central question is that should the suspension be based on the complications recorded recently or on the premise that it is being used off label for the treatment of eye diseases? It is pertinent to know that while it is in tendon with global best practice for a drug to be recalled from circulation as a result of potential hazard it constitutes to health of populace, it is however not withdrawn due to adverse reactions developed by some the drug users. On the contrary, the drug is only contraindicated in such susceptible individuals. For example, Timolol and Nifedipine are used in the treatment of glaucoma and hypertension respectively. However, when used in patient with Asthma, it can potentially lead to death due to obstruction of airways induced by the drugs in them. Nevertheless, the danger associated with usage of b-blockers in asthmatic was never cogent enough to deny the teeming non-asthmatics the benefits of the drug.
On the other hand, a drug can be withdrawn from circulation by its manufacturer or concerned regulatory bodies such as Food and Drug Administration (FDA) in US or NAFDAC in Nigeria following empirical evidence that it poses danger to the general health of the public. On July 03, 2019, Altaire Pharmaceuticals, Inc withdrew its brand of over-the-counter ant allergy drug called Equate and Support harmony in United States. The reason was potential for nonsterility. Similarly, Macleods Pharmaceutical Limited in the USA, withdrew from the market Losartan Potassium 50mg and Losartan Potassium/Hydrochlorothiazide combination tables and the withdraw was based on detection of NMBA(N-Nitroso-N Methy-4-aminobutyric acid) impurity. In Nigeria, NAFDAC in 2008 banned the sale of children killer, my Pikin produced by Barewa Pharmaceuticals, following death of 84 children who ingested the syrup. The death was attributed to the presence of a chemical called diethylene glycerol detected in the syrup. Therefore, is it appropriate for senate to order the suspension of the drug without carrying out its due diligence with respect to the matter?
Additionally, should importation of Avastin be suspended because it being used off- label? Off-label means a drug is being used in manner not specified by the manufacturer. For example. Avastin was primarily anticancer but at a low dose it is being injected into the eye for treatment of condition like age-related macular degeneration, diabetic macular edema etc. In medical practice, off-label prescription is entirely legal and very common. In United States for instance, according to webmd.com, more than one out of five prescriptions are off-label therapies. Furthermore, there are other drugs being administered off-labels. Prazocin was approved for use of hypertension but is being used in the treatment of nightmares after post-traumatic stress disorder. Study has shown that Clomid used for treatment of female infertility improves sperm count, motility and morphology in men with low sperm count after three month therapy. Hence, it is used in the current management of male infertility. Therefore, banning of Avastin as off-label should logically be extend to all other drugs being used off-label.
I think the discourse should be centered on the victims and how they could be assisted to continue to regain their sight. The big relief is that most of them had regained their sight as reported by daily trust and leadership newspaper and many had testified to the commitment of the hospital to their plight. Healing process takes a natural course and unless it’s complete the final outcome can’t be known with certainty. Besides many people died on operation table even in the best of centres. Stella Obasanjo
dSied in a German hospital.
Nigerian senate should use the opportunity of the current situation to review our national health insurance scheme to incorporate people from informal sector and to also strengthen our primary health care centres with equipment and manpower in order to ensure universal health coverage. I conclude with an anonymous quotation; ‘’When you change the way you are looking at things, the things you are looking at change.’’
Abdullahi Sadiq Mohammed