Tag: NAFDAC

  • Osinbajo welcomes report on COVID-19 treatment drug

    Osinbajo welcomes report on COVID-19 treatment drug

    Vice President Yemi Osinbajo has welcomed efforts by a team of Nigerian professors and scientists investigating the effectiveness of, and roles that Ivermectin drug can play in the treatment of the Coronavirus disease.

    The team, which is composed of Nigerian scholars at home and abroad, has also submitted their report on the usefulness of the drug to the World Health Organisation which has already appointed a Peer Review expert from the United Kingdom.

    Speaking yesterday while being briefed on the report by a team of scientists led by Prof. Femi Babalola, the Principal investigator, and Prof. Chris Bode, the Chief Medical Director of LUTH, the Vice President expressed excitement that Nigeria and Nigerians “are at the cutting edge of scientific research into the COVID-19 treatment.”

    According to him, “we have an opportunity here and I am so fascinated to hear this drug has been used in the treatment of River Blindness in this country.”

    While commending the efforts of the team, Prof. Osinbajo added that with the report, Nigeria is at an advantage both in knowledge and availability of the drug, especially since Ivermectin has been found useful not only in the treatment of COVID-19, but also as a prophylactic medication.

    He disclosed that the Federal Government will explore further ways to support the research for the benefit of Nigerians and humanity generally, while also advancing the effective funding of scientific research in the country.

    Members of the group named IVERCOVID Research Group are the Principal Investigator, Prof. Femi Babalola, an Ophthalmologist and surgeon; the Chief Medical Director of LUTH, Prof. Chris Bode; the Chairman of the Medical Advisory Council at LUTH, Prof. Lanre Adeyemo; a US-based Clinical Pharmacologist, Prof. Adesuyi Ajayi; two project virologists: Prof. S.A Omilabu and Dr. Olumuyiwa Salu; and also the Project Coordinator, Dr. Felix Alakaloko.

    Both Prof. Babalola and the CMD, LUTH commended the Buhari Presidency for encouraging the research and thanked the Vice President for his personal role and support.

    The report is titled, “A randomised controlled trial for the repurposing of Ivermectin in the management of COVID-19,” and highlights are discussed below:

    The research, carried out in the Lagos University Teaching Hospital (LUTH) was undertaken following the report of a 5,000-fold reduction in viral load by Australian workers with in-vitro use of Ivermectin on COVID-19 in culture.

    The PI has worked extensively with Ivermectin on the Onchocerciasis-River Blindness control programme, through which many Nigerians have used Ivermectin.

    FINDINGS

    The study revealed that the mechanism of action of Ivermectin, include “Inhibiting viral entry into cells nucleus; and “Direct suppression of viral RNA load of SARS CoV 2,” among others.

    Ivermectin is orally absorbed with higher absorption as a solution better than tablets, and “The Mean Residence Time” (MRT) is 3.4 days. This informs the suggested frequency of dosing, i.e. twice a week.

    The research’s Null hypothesis noted that: “Safe doses of Ivermectin are not useful in the treatment of patients with virology proven COVD-19 disease, does not lower viral load, and does not shorten time to negativity, neither does it cause improvement in clinical parameters when compared to Lopinavir/Ritonavir/Placebo.”

    But its Alternative Hypothesis revealed that, “Safe doses of Ivermectin are useful in the treatment of patients with virology proven COVID-19 disease, lowering viral load, shortening time to negativity, and causing improvement in clinical parameters when compared with Lopinavir/Ritonavir/Placebo.”

    RESULTS

    In its results so far, the Study noted that the randomisation was effective based on distribution of age, sex and some clinical presentation at baseline such as cough and fever.

    The overall results showed that the “Days-To-Negative (DTN) reduced by 3.8 days overall. While a few patients are negative by day two, 50 per cent are negative by day 5.”

    The study indicated that Clinical trials of Ivermectin have been carried out in at least 21 countries worldwide, including Nigeria. It referenced the “Meta-analysis of clinical trials of Ivermectin to treat COVID-19 infection” by Dr. Andrew Hill, Department of Pharmacology, University of Liverpool, UK.

    Highlighting the practical applications, the Study proposed that “Ivermectin should be considered for adoption into the uniform treatment guidelines of COVID- 19 in Nigeria,” noting the “potential use of ivermectin as prophylaxis Pending the rollout of vaccination programs or alongside it.”

    However, the Study emphasized that Ivermectin “is not meant to replace other COVID-19 measures such as social distancing, face masking and hygiene, or vaccinations,” adding that, “It is possibly an additional tool which can be deployed to fight the pandemic.”

    The group stated that it has forwarded a report of its findings to NAFDAC.

  • What NAFDAC will do before COVID-19 vaccination will commence in Nigeria

    What NAFDAC will do before COVID-19 vaccination will commence in Nigeria

    Before any Coronavirus disease (COVID-19) vaccine would be administered in Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC) will first certify it safe for human use.

    The National Primary Health Care Development Agency (NPHCDA) made this known on Monday, while stressing that pregnant and lactating mothers cannot receive COVID-19 vaccine.

    According to the NPHCDA, studies are yet to be conducted to ascertain the safety of the vaccine on pregnant and lactating mothers.

    The agency also stated that COVID-19 vaccine does not contain any harmful substance or micro-chip.

    “All vaccines including COVID-19 vaccines are manufactured under strict compliance with WHO guidelines.

    “Also, before the vaccine is administered in Nigeria, NAFDAC will certify it safe for human use.

    “COVID-19 vaccination is especially important for people with underlying medical conditions such as heart disease, lung disease, diabetes, cancer, etc. People with these conditions are more likely to get very sick from COVID-19.

    “The vaccine does not cause the disease but helps the body to develop immunity against the disease.

    “Mild side effects may occur as in any other vaccinations. However, they are signs that the vaccine is working to build your immunity. This does not mean you have COVID-19. If they do not go away in a few days, please see your doctor.

    “Before a vaccine is certified for use, it must receive approval from WHO. Here in Nigeria, in addition to WHO approval, all vaccines including COVID-19 vaccine are certified safe for use by NAFDAC.

    “Even when in use, NAFDAC continues to monitor to ensure it causes no harm,” NPHCDA stated.

    TNG reports Nigeria plans to introduce the COVID-19 vaccine in the 1st Quarter of 2021 to halt the ongoing spread of the virus and to save lives.

    Once the vaccine is available, there will be public announcements on when and where to get the vaccine, according to the NPHCDA.

  • Probe missing N3.8bn in health ministry, NAFDAC, others, SERAP tells Buhari

    Probe missing N3.8bn in health ministry, NAFDAC, others, SERAP tells Buhari

    The Socio-Economic Rights and Accountability Project (SERAP) has asked President Muhammadu Buhari to “probe allegations that ₦3,836,685,213.13 of public funds meant for the Federal Ministry of Health, teaching hospitals, medical centres, and National Food Drug Administration and Control (NAFDAC) are missing, mismanaged, diverted or stolen.”

    SERAP in a statement issued on Sunday by its Deputy Director, Kolawole Oluwadare, called on President Buhari to direct the Minister of Justice/Attorney General of the Federation, Abubakar Malami to commence an investigation into the alleged stolen funds.

    According to the organisation, the allegations are documented in Part 1 of the 2018 audited report released last week by the Office of the Auditor-General of the Federation.

    The group also wants the President to “promptly investigate the extent and patterns of widespread corruption in the Federal Ministry of Health, teaching hospitals, medical centres, neuro-psychiatric hospitals, National Health Insurance Scheme, and NAFDAC indicted in the audited report, and to clean up an apparently entrenched system of corruption in the health sector.”

    “Corruption in the health sector can cause serious harm to individuals and society, especially the most vulnerable sectors of the population. These missing funds could have been used to provide access to quality healthcare for Nigerians, and meet the requirements of the National Health Act, especially at a time of the COVID-19 pandemic.”

    “The Federal Ministry of Health, Abuja spent without approval ₦13,910,000.00 to organize a 2-day Training and Bilateral discussion with Chief Medical Directors and Chairmen Medical Advisory Council and the Ministry of Budget and National Planning to prepare 2019 Personnel Budget. ₦4,860,000.00 was originally budgeted for the programme.”

    “The National Food Drug Administration and Control (NAFDAC) paid ₦48,885,845.00 for services not rendered and goods not supplied. According to the Auditor-General, NAFDAC used fake and fictitious receipts for these payments. NAFDAC also paid ₦25,734,018.49 to companies/firms who were never awarded any contracts and never executed them.”

  • Skin whitening: NAFDAC warns Nigerians against use of very popular cream

    Skin whitening: NAFDAC warns Nigerians against use of very popular cream

    The National Agency for Food and Drug Administration and Control (NAFDAC) on Monday issued a strong warning to members of the public against the use of BB Glow Soul body cream.

    The warning is contained in a statement signed by the Director-General of the agency, Prof. Mojisola Adeyeye and made available to newsmen in Abuja.

    According to Adeyeye, NAFDAC has been informed that the Malaysian National Pharmaceutical Regulatory Agency (NPRA) had banned the product having found it injurious to health.

    She said that the product had been found to contain Hydroquinone and Tretinoin, which she said could cause redness of the skin, hypersensitive skin as well as increase in the risk of skin cancer.

    “Hydroquinone causes redness of the skin, discomfort, unwanted skin changes, the skin becomes hypersensitive, can prevent pigmentation (depigmentation).

    “It could also reduce skin protection against harmful UV rays; the use of Tretinoin without the supervision of health professionals can cause the skin to be reddish, uncomfortable, painful, peeling and hypersensitive to sunlight.

    “NAFDAC implores importers, distributors and retailers to immediately stop the importation, distribution and sale of BB Glow Soul Cream cosmetic products.

    “Any member of the public in possession of the implicated cosmetic products is implored to submit them to the nearest NAFDAC office,’’ Adeyeye urged.

    She further encouraged healthcare professionals and consumers to report adverse events or side effects related to the use of the product to the nearest NAFDAC office and NAFDAC PRASCOR (20543 TOLL FREE from all networks.

    The D-G added that Nigerians could also report the effects of this product via pharmacovigilance@nafdac.gov.ng or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng.

  • Hooligans, criminals feeding Buhari daily with ‘NAFDAC approved lies’ – Father Mbaka

    Hooligans, criminals feeding Buhari daily with ‘NAFDAC approved lies’ – Father Mbaka

    The Spiritual Director of Adoration Ministry, Enugu State Rev. Fr. Ejike Mbaka has said President Muhammadu Buhari encircled himself with hooligans and criminals feeding him daily with ‘lies with NAFDAC number’.

    Mbaka who was a visible supporter of the president in the build up to the 2015 polls said he expected Buhari to effect the much needed change Nigerians yearned.

    Mbaka also accused security men in Enugu State of killing and dumping several bodies of some #EndSARS protesters into the Onyeama valleys.

    The controversial Catholic priest, who disclosed this during his Sunday ministration, asked Buhari to apologise to the country, especially the youth, on behalf of himself and his predecessors, who had also caused Nigerians so much pain.

    Mbaka, while delivering a message titled, ‘Impure Heart’, at the 2020 All Saints Day Holy Mass, stated that pure heart begets pure spirit while impure heart begets evil spirit.

    He alleged that many youths were being detained in various correctional centres across the state and the country, declaring that it was rather the Nigerian leaders that should be in those correctional centres.

    Mbaka warned that the detention and extrajudicial killing of pro-Biafra agitators should cease forthwith, saying, “They should not touch any of those Biafra boys o!”

    Clarifying that his message was not targeted at any particular government or individual but bad governance in general, Mbaka added, “This is not about #EndSARS or IPOB. Nobody is fighting any government; we are fighting bad governance.

    “Few days ago, at Miliken Hill, after New Market, (in Enugu), people discovered corpses of those that were shot and killed during the recent protest. They dumped people’s corpses there while families of those young men and women continued searching for them.

    “That is why I am telling you that Nigeria can never be the same again. Did you expect these young men to keep watching the country being swindled and looted dry by the so-called leaders?”

    He said, “Buhari, who could have been a solution to this, succeeded in encircling himself with criminals and hooligans. People, who do not just tell him lies but rather, they magnify lies; lies with NAFDAC number – and feed him.”

     

  • NAFDAC says drugs looted by hoodlums dangerous

    NAFDAC says drugs looted by hoodlums dangerous

    The National Agency for Food and Drug Administration and Control (NAFDAC) has warned residents of Kaduna State on the health risk of drugs allegedly looted from a warehouse in the state.

    NAFDAC gave the warning in a statement issued by the state Commissioner for Internal Security and Home Affairs, Mr Samuel Aruwan, made available to newsmen in Kaduna on Sunday.

    The agency said that the items were looted on Oct. 24 in a warehouse located at Narayi in Chikun Local Government area of the state.

    The looted items, it said, included expired, prohibited and dangerous drugs, adding that anybody who consumed such drugs risked serious illnesses and death.

    NAFDAC also quoted the management of a food processing company, whose stores were also looted in Kakuri, as saying that the stolen grains had been treated with chemical preservatives.

    It said that such chemical preservatives had rendered the items as unsafe for consumption.

    “Residents of Kaduna State are hereby notified to be vigilant and careful about the sources of the food and medications they take and where they buy them, to avoid these dangers.

    “NAFDAC, on behalf of the Kaduna State government, appeals to the public for information on the identities of the looters and where they might be hiding the stolen items,” it said.

    The statement, which quoted the NAFDAC Director-General, Prof. Mojisola Adeyeye, as expressing shock over the said looting and mindless destruction of the agency’s property at the warehouse, thanking God, however, that no life was lost during the incident.

    Adeyeye commended the state government for taking prompt action to safeguard the health of the citizens.

    NAFDAC, however, said that it had made concerted efforts to beef up security around its facilities nationwide to forestall a recurrence.

  • NAFDAC to phase out production of alcohol in sachets 2023/2024

    NAFDAC to phase out production of alcohol in sachets 2023/2024

    The National Agency for Food and Drug Administration and Control (NAFDAC) says it will totally ban production of alcohol drink in sachets by 2023/2024.

    Its Director-General, Prof. Mojisola Adeyeye, told the News Agency of Nigeria (NAN) on Wednesday that banning of the product would come in phases.

    Adeyeye said that alcohol drink in sachet would be phased out by 2023 ending or first week of 2024, when it would no longer exist in the society.

    NAN reports that Adeyeye, had earlier expressed worry over the sale and consumption of alcoholic beverages in sachets and small volume glass and Poly-Ethylene Terephthalate (PET) bottles.

    She also decried the negative effects of irresponsible alcohol consumption on public health and on the safety and the security of the public.

    Adeyeye said with the support of the Federal Ministry of Health, the concern also relates to the fact that alcohol “is also a toxic and psychoactive substance with dependence producing properties.

    According to her, uncontrolled access and availability of high concentration alcohol in sachet and small volume PET or glass bottles have been put forward as a factor contributing to substance and alcohol abuse in Nigeria with its negative impact on the society.

    She said the World Health Organisation (WHO) reports that alcohol consumption contributes to three million deaths each year globally as well as to the disabilities and poor health of millions of people.

    Adeyeye said that stakeholders had already met on this to outline the negative impact of the product on the society, particularly on youths.

    “NAFDAC and the Federal Ministry of Heath met on this issue with the distillers association, a couple of days ago.

    “We let them know that they can think of business because there is nothing wrong about that.

    “NAFDAC and Federal Ministry of Heath also have to think about the society, we had series of meetings at the ministry.

    “We all agreed that we are going to carry out the ban in phases,” she said.

    The director-general also said that, pending the time lapse, the distillers association were told to reduce the level of alcohol drink in sachets, and that they have agreed to do that.

    Adeyeye said the distillers association had also been tasked to run a social responsibility campaign against underage drinking, adding that a jingle would soon be on air in this regards.

    She, however, called on Nigerians to always do things that would depict the moral values enshrined in the nation’s system.

  • COVID-19: FG to support NAFDAC on vaccine research to meet global standard

    COVID-19: FG to support NAFDAC on vaccine research to meet global standard

    The Minister of Health, Dr Osagie Ehanire, says the Federal Government will support the National Agency for Food and Drug Administration Control (NAFDAC), to meet international standards in researches into the development of a vaccine for the Coronavirus.

    Ehanire said this at the Presidential Task Force on COVID-19 joint briefing on Thursday in Abuja.

    He said the government would support NAFDAC to reach international maturity level and encourage researchers to work towards the development of vaccines for the virus.

    Ehanire said Nigeria participated in a World Health Organisation (WHO), African Regional Conference, held virtually and chaired by the Minister of Health of the Congo.

    He said the conference was centered on COVID-19, adding that conversation were on vaccines and implementing the African Region sickle cell strategy.

    “We shall sustain our interest in developments around COVID-19 and seek opportunities to exchange ideas with countries and organisations investing in new knowledge.

    NAFDAC is also trying to reach the maturity level to assure that the product and processes that come out of research work in Nigeria towards the development of vaccine candidates are realizable and that they meet the required standard

    “The onus lies not only with the Ministry of Health, but is a shared responsibility with the populace.

    “Our safest, easiest and cheapest option of achieving a balance between saving livelihood and saving lives remains adherence to non-pharmaceutical measures, as we have preached so many times. With these measures, we can balance and uphold our indices, even as we reopen our economy.”

    The minister, however, urged Nigerians not to relax in observing the COVID-19 preventive measures, saying that the virus would still remain for the foreseeable future, till there was a vaccine available for it.

    With the imperative to reopen the economy, relax local and international air travel to support restoration of livelihoods, the minister noted that the experience in other countries was that COVID-19 infection rates have gone up and in some cases, dramatically.

    Ehanire, therefore, said Nigerians must strive not to lose its attention to preserve lives or lose the gains it has made over the months.

    He also said that training and retraining on infection prevention and control was ongoing in all health facilities as well as ensuring availability of PPE as an investment, to continue the reduction in health worker infections.

    Ehanire called on health workers to ensure judicious and prudent use of PPE materials, while observing full Information Prevention Control (IPC), measures.

    The minister recalled that Nigeria, was on Aug. 25, declared poliovirus free, he therefore, said all material and human resource assets from polio eradication would be deployed to surveillance and fighting other disease outbreaks, including the fight against the COVID-19 pandemic

  • Chloroquine kills coronavirus in early stage – NAFDAC

    Chloroquine kills coronavirus in early stage – NAFDAC

    Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC) Prof. Mojisola Adeyeye on Tuesday stated that pieces of evidence from reliable researches and reports showed that Chloroquine can kill COVID-19 virus at the early stage.

    She stated that Remdesivir, made by Gilead Sciences Inc, has also been shown to kill the virus at late stages.

    The NAFDAC boss, however, noted that the cost for treating people with chloroquine was way cheaper than with Remdesivir. Remdesivir cost $2,500 to treat an average patient and Chloroquine is $10.

    She also noted that countries in West Africa like Ghana, Togo, and Senegal have also embraced the clinical use of Chloroquine for treatment.

    Prof. Adeyeye spoke on Tuesday during a virtual news conference in Abuja.

    She said: “In March 20, this year, just before the lockdown, I had a press briefing. At that time, people did not understand what clinical trial treatment meant. Once they hear treatment, they think you can use it anyhow. But clinical trial treatment is a research study to see whether the drug will work or not.

    “In the press briefing, I said I was going through literature to see what others have done and I saw in a particular literature a reliable publication of an article about Chloroquine and Remdesivir (that time nobody was even talking of Remdesivir). This was February of this year.

    “They said in the cell culture, Remdesivir and Chloroquine killed COVID-19 viruses, that is, invitro – in the laboratory. But you cannot translate that to humans unless a clinical trial is done.

    “I kept looking. About two weeks or so later in early March (this was at a time when COVID-19 was at its peak in China); there was a publication where 100 patients were treated with Chloroquine across ten hospitals in six cities, including Wuhan. It said that all of them recovered from the symptoms. They called it that time pneumonia symptom.

    “In the cells, in the lab, Remdesivir and Chloroquine killed COVID-19. At what stage would they be more effective? We didn’t know at that point. Now, we are realizing that Chloroquine is effective at the early stage.”

    She said she was watching CNN about four or five days ago and for the first time, Sanjay Gupta, an American neurosurgeon, medical reporter, and writer, mentioned that Chloroquine can be used prophylactically.

    The NAFDAC D-G noted: “Remember, Remdesivir and Chloroquine work in the cells. Chloroquine was proven to work in 100 patients. We did not know at that time that the disease has about four phases – pre-exposure stage, early stage, mild stage, and the severe stage.”

    Prof. Adeyeye added: “Now we are talking of Remdesivir. We met with Gilead – the maker of Remdesivir about two months ago and they came. They said they have licensed their drug to five Indian companies and one Pakistani company. To treat an average patient will cost about $10 with Chloroquine and cost about $2,500 with Remdesivir.

    “When we now got the profile of Remdesivir, what was recorded in literature and from the manufacturer was that Remdesivir doesn’t work at the early stage. It works at the late stage. But when viruses are in the tube in the laboratory, you won’t know which is late or which is early. Both killed them. We now understand that it is not only one drug that can be effective for COVID-19, but it depends on the stage and the phases of the disease.”

  • NAFDAC warns Nigerians against apple, blackcurrant from Australia

    NAFDAC warns Nigerians against apple, blackcurrant from Australia

    The National Agency for Food and Drug Administration and Control (NAFDAC) has cautioned Nigerians to stop the consumption of an organic apple and black currant originating from Australia.

    Prof. Moji Adeyeye, NAFDAC Director-General, who disclosed, said the products had been certified harmful for human consumption.

    “The Centre for Food Safety (CFS) of Hong Kong’s Food and Environmental Hygiene Department has warned against the consumption of Pure Tassie Organic Apple and Blackcurrant Juice originating from Australia.

    “This was due to unacceptable level of patulin (a mycotoxin) which had exceeded the maximum limit in fruit juice,” she said.

    Adeyeye pointed out that the level of patulin content in the affected fruit juice can induce liver, spleen and kidney damage.

    She added that the toxic level would affect immune system and causes nausea, gastrointestinal disturbance and vomiting.

    She said that the name of the is Pure Tassie, an organic apple and blackcurrant juice from Australia.

    The D-G implored importers, distributors, retailers and consumers to immediately stop the importation, distribution, sale and consumption of the affected fruit juice.

    She urged members of the public in possession of the affected fruit juice to submit stock to the nearest NAFDAC office.

    She also called on healthcare professionals and consumers to report adverse events or side effects related to the use of this product to the nearest NAFDAC office through NAFDAC PRASCOR (20543 TOLL FREE from all networks).

    Adeyeye said the agency should be reached through pharmacovigilance@nafdac.gov.ng or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng.