By; JACOB ONJEWU DICKSON
Director-General of NAFDAC, Prof Mojisola Christianah Adeyeye has ordered for the manufacturing of Chloroquine for Emergency Stock for possible clinical trial treatment of Coronavirus.
This was contained in a statement signed by the NAFDAC DG, made available on Monday March 30, 2020.
“In a very recent publication, chloroquine was reported in a press briefing by the State Council of China, indicating that chloroquine phosphate had demonstrated marked efficacy and acceptable safety in treating #COVID19 associated pneumonia in a multi-center clinical trials conducted in China.
“The study involved 10 hospitals and 100 patients. The investigators reported that chloroquine phosphate is superior to the control in inhibiting the pneumonia associated with #COVID19, and shortening the course of the disease.
“Chloroquine was discontinued in Nigeria many years ago for use as antimalarial because of the resistance that the parasite developed against the drug. Therefore, sourcing the raw material – active pharmaceutical ingredient (API) – chloroquine phosphate could be difficult,” she said.
She informed that May & Baker, a member of Pharmaceutical Manufacturing Group of Manufacturing Association of Nigeria (PMGMAN), whose flagship product in the past was chloroquine, had NAFDAC approval for the production of the drug as antimalarial many years ago before the discontinuation.
“May & Baker was able to get the API and was asked to manufacture a batch for emergency stock just in case more people become exposed and infected with the virus. The batch has been manufactured and the company plans to make more batches if needed.
“Other researchers in France, US have used the drug for clinical trial treatment of #COVID19 and they reported effectiveness of the drug. Lagos State will be starting a clinical trial on chloroquine to evaluate the effectiveness,” she explained.
NAFDAC however, adviced the public to desisting from its use without the guidance of a medical doctor or clinician for cases of clinical trial treatment of #COVID19.
” It has side effects such as gastrointestinal upset, blurred vision, headache and pruritis (itching). The itching can be relieved by using antihistamine. Prolonged use can also cause retinopathy or vision impairment,” it warned.
It added that, “The Agency, through her regulatory activities will ensure that the clinical trial protocol guidelines are followed and wishes the clinical research teams great success in stopping the raging pandemic. The mandate of NAFDAC is to safeguard the health of the country.”