Should NAFDAC continue Hydroxychloroquine/ Chloroquine trial despite WHOs directive?
Chloroquine and Hydroxychloroquine are derived from the Quinoline molecule and both have similar properties, they have antimalaria properties but Hydroxychloroquine also has anti-rheumatoid properties.
At the moment WHO is currently assessing the use of hydroxychloroquine on COVID-19 patients within the Solidarity Trial. The hydroxychloroquine arm has been paused as a precaution while the safety data is being reviewed.
If NAFDAC has already started the clinical trials with hydroxychloroquine /chloroquine, and if they have already enrolled people in the trial, WHO has advised that;
Those patients previously randomized to hydroxychloroquine treatment should continue to receive hydroxychloroquine until they finish their course of treatment. The use of hydroxychloroquine and chloroquine are accepted as generally safe for use in patients with autoimmune diseases or malaria. The Executive Group of the Solidarity Trial decided to implement a temporary pause of the hydroxychloroquine arm within the trial as a precaution while the safety data is being reviewed.
An observational study published in the Lancet on 22nd of May found that, among 100 000 patients from multiple countries randomized to receive hydroxychloroquine, when used alone or with a macrolide, there was a higher mortality rate and an increased frequency of irregular heartbeats.
A final decision on the harm, benefit or lack of benefit of hydroxychloroquine will be made once the evidence has been reviewed by the Data Safety Monitoring Board. This review will include data from the Solidarity Trial and other ongoing trials, as well as any evidence published so far. It is expected by mid-June.
From my observation, it seems some Nigerians have started self-medicating on hydroxychloroquine and chloroquine in a bid to prevent contracting coronavirus.
I think NAFDAC should carefully consider the LANCET study and ensure they protect the lives of Nigerians and reduce the incidence of drug misuse/abuse by providing public health enlightenment.
What bothers me most is the chaotic drug distribution we have in Nigeria. Chloroquine and Hydroxychloroquine are both prescriptions only medicines and should be used under the recommendation of a clinician for the treatment of a particular ailment with stated dose and duration of therapy. Both drugs should not be taken as multivitamins or over the counter (OTC) medication.
There are serious side effects and adverse effects that could occur as a result of self-medication and drug misuse.
Side effects include:
· Visual disturbances: in cases of long-term use, regular ophthalmological exams are recommended
· Irreversible retinopathy: key fundoscopic feature is Bull’s eye maculopathy
· Reversible corneal opacity
· Blurred vision
· Gastrointestinal: e.g., nausea with cramps (most common), anorexia, vomiting
· Neurologic: e.g., sensorineural deafness, tinnitus, cranial nerve palsies, and myasthenia-like muscle weakness
· Dermatologic: e.g., photosensitivity, pruritus, alopecia, bleaching of hair
Reference: WHO, Assessed 26/5/2020