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Tag: NAFDAC

  • NAFDAC approves more vaccines for COVID-19

    NAFDAC approves more vaccines for COVID-19

    The National Agency for Food and Drug Administration and Control (NAFDAC) has approved more vaccines for the treatment of the Coronavirus (COVID-19) pandemic.

    The Director General of the agency, Prof. Mojisola Adeyeye, disclosed this at a news conference in Abuja on Thursday.

    She said approval had been given to Moderna, a vaccine from the Rovi Pharma Madrid, Spain.

    Other vaccines also approved are: AstraZeneca AZD1222 produced by SK Bioscience Company Limited from Korea and Sputnik V, produced by Gamaleya National Centre of Epidemiology and Microbiology, Russia.

    Adeyeye said that the NAFDAC Vaccine Committee had been carefully assessing the vaccines and several others in spite of
    the approval by stringent regulatory countries and the World Health Organisation (WHO) Emergency Use Listing (EUL).

    She added that all the COVID-19 vaccines that had gone through the process of approval had been certified for quality, safety and efficacy evaluation, a prerequisite for acceptance by COVAX facility.

    According to her, most regulatory agencies across the world use this mechanism to expedite their own regulatory approval to import and administer the vaccines.

    She noted that NAFDAC spent 15 days to thoroughly examine the dossier or submission package of the vaccines to ensure that the benefits outweighed the risks and any other side effect for proper monitoring.

    She said “the EUL will allow Nigeria to receive supplies of the vaccines from the COVAX facility. COVAX is the pillar of the Access to COVID-19 Tools (ACT) accelerator’s jointly led by the Global Alliance for Vaccines and Immunisation (GAVI) and the Coalition for Epidemic Preparedness Innovations (CEPI) and the WHO.

    “Its aim is to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access to low-middle income countries (LMIC) of which Nigeria is one.

    “NAFDAC also gives full review for vaccines that have not gone through EUL route. This mechanism is explained in our guidance developed by the COVID-19 Vaccine Committee.”

    On Moderna and AstraZeneca AZD1222 vaccines, the director general said that the vaccines had received WHO EUL and were given accelerated approval, while Sputnik V was yet to receive the EUL approval, subjected to six months review by NAFDAC.

    She said that NAFDAC was granted access to the dossiers and prior assessment reports of Moderna and AstraZeneca AZD1222 from the WHO website at different times over the past two months.

    According to her, the Moderna vaccine is presented as a white to off-white, ready-to-use dispersion for intramuscular injection in a
    multi-dose vial containing 6.3ml (10 doses in a 10-vial pack, adding that, each dose have (0.5ml) contains 100 micrograms of messenger RNA, and is given as two dose vaccine.

    She said that unopened vaccine vials could be stored or transported frozen at -25 degree centigrade to -15 degree centigrade for up to seven months and 30 days when stored at 2 to 8 degree centigrade, protected from light.

    She added that the AstraZeneca AZD1222 is a recombinant ChAdOx adenoviral vector encoding the structural surface glycoprotein (Spike protein) antigen of the SARS-CoV-2.

    Adeyeye said that the AstraZeneca AZD1222 vaccine solution is colourless to slightly brown, clear to slightly opaque packed as a 5ml solution that contains 5 x 10 virus particles for injection in a 5ml clear glass multidose vial that could be stored at 2 to 8 degree centigrade, and is given as two dose injection.

    On Sputnik V vaccine which is also known as Gam-COVID-Vac COVID-19 vaccine, NAFDAC DG said “it is supplied as a two-component product, both of which are 3ml (5 doses) solution for intramuscular injection in glass vial.

    “It is a two-dose injection. Each 0.5 ml dose of the component I is formulated to contain virus particles (1.0+0.5) x 10 of Ad26 vector encoding the S glycoprotein of SARS-CoV-2,” adding that the product has a shelf life of six months when stored at -18 degree centigrade or three months when stored at 2-8 zero degree centigrade.

    Adeyeye said the agency did a thorough assessment of each vaccine and were found to have the quality, safety and efficacy attributes, with the benefits far outweighing the risks.

    She said that the pharmacovigilance unit would conduct safety and monitoring studies on the vaccines to record the side and adverse effects following immunization.

    She further said that other studies like immunological responses, incidences of reactogenicity and possible dose optimisation would be done in a cohort of vaccines.

    The director general added that the agency would be using its recently launched Med Safety App for active pharmacovigilance of the vaccines in collaboration with respective sister agencies, and urged healthcare workers to download same App to monitor Adverse Drug Reaction (ADR) and report.

    She said NAFDAC had begun in-country training on the use of the App for healthcare workers.

    She noted that the agency planned to also use the traceability with GS1 technology to monitor vaccines distribution using Global Trade Item (GTIN), adding that “all these were to prevent fake vaccines from infiltrating the supply chain and to ensure there was no diversion.”

  • NAFDAC cautions Nigerians against sanitisers with Methanol

    NAFDAC cautions Nigerians against sanitisers with Methanol

    The National Agency for Food and Drug Administration and Control (NAFDAC) has again cautioned Nigerians against the use of hand sanitizers especially Nutricional S, de R, L De C.V containing methanol.

    The warning is contained in a public alert with No: 20/2021 tagged “Recall of Hand Sanitizers by DiBAR Nutricional due to the presence of Methanol (Wood alcohol).

    The alert was signed and released by the Director General of the agency, Prof. Mojisola Adeyeye in Abuja on Sunday.

    She said that the agency had received information from US Food and Drug Agency (FDA) about the presence of methanol in hand sanitizers.

    She added that information from FDA noted that Nutricional S,de R,L De C.V (Dibar) is recalling all Dibar Labs hand sanitizers, ProtectoRX hand sanitizers and Advance hand sanitizers due to the presence of methanol.

    According to her, methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested.

    “Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.

    “All persons using these products on their hands are at risk for methanol poisoning, young children who accidently ingest these products and adolescents and adults who drink these products as alcohol (ethanol) substitute, are most at risk.

    “Methanol is not an acceptable ingredient for hand sanitizers and must not be used due to its toxicity,” she stressed.

    Adeyeye therefore called on consumers, who have been exposed to hand sanitizer containing methanol and are experiencing symptoms, to seek immediate treatment for potential reversal of toxic effects of methanol poisoning.

    According to her, the call is necessary at this time after the FDA analysis has found the product to contain methanol in lab testing.

    Adeyeye stated that NAFDAC implores importers, distributors, retailers and consumers to exercise caution and vigilance to avoid the distribution, sale and use of methanol alcohol-based hand sanitizers.

    She also called on healthcare providers and members of the public in possession of methanol alcohol-based hand sanitizers to discontinue sale and use or submit stock to the nearest NAFDAC office.

    She said that healthcare professionals are encouraged to report any problem related to the use of any hand sanitizers to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks).

    According to her, Nigerians could also report any adverse effect through viapharmacovigilance@nafdac.gov.ng or via e reporting platform available on NAFDAC websites www.nafdac.gov.ng as well as Med Safety application available for download on Android and IOS.

  • NAFDAC destroys unwholesome products worth 515m in Gombe

    NAFDAC destroys unwholesome products worth 515m in Gombe

    The National Agency for Food and Drug Administration and Control (NAFDAC) on Saturday, destroyed various categories of harmful products worth about N515.7 million in Gombe.

    Speaking at the venue of the exercise, Prof. Christianah Adeyeye, the Director General (DG) of NAFDAC, said the items were from the six states in the North-East.

    Adeyeye said the products destroyed were made up of substandard, fake and falsely labelled unwholesome food products and chemical.

    The News Agency of Nigeria (NAN) reports that the product destroyed included antibiotics, anti hypertensive, anti diabetic and anti malaria drugs.

    Others were spaghetti, vegetable oil, non alcoholic beverages, body cream, fake insecticide and fertilisers, among others.

    The DG, represented by Mrs Josephine Dalym, Coordinator, NAFDAC, Bauchi State, said the destruction of the products would no doubt eliminate the risk of their reintroduction into Nigerian markets.

    She gave the assurance that NAFDAC ‘s collaboration with other regulatory agencies and stakeholders would be sustained to rid the region of fake and harmful products.

    Adeyeye also drew the attention of the public to the presence of counterfeited COVID-19 vaccine in the continent.

    She appealed to the general public to cooperate with NAFDAC in its effort to eradicate the menace of drug and substance abuse from society.

    Mr Gonzuk Bedima, the NAFDAC Coordinator in Gombe State, in his address of welcome, said there was synergy between NAFDAC and other regulatory agencies in the state.

    He further called for continued support which he said would go a long way in regulating circulation of unwholesome products in the market.

    “Let’s join our hands together to save lives and have zero tolerance of unwholesome, fake and counterfeited products,” he said.

  • NAFDAC approves Pfizer COVID-19 vaccine

    NAFDAC approves Pfizer COVID-19 vaccine

    The National Agency for Food and Drug Administration and Control (NAFDAC) has approved Pfizer COVID-19 vaccine for use in Nigeria.

    Before now, Nigeria procured Oxford/AstraZeneca COVID-19 vaccine, which is being administered across the country currently to check the spread of coronavirus.

    Director-General, NAFDAC, Prof Mojisola Adeyeye disclosed this on Friday at a news conference in Lagos, Southwest Nigeria.

    Adeyeye said the vaccines were reviewed carefully by the NAFDAC staff COVID-19 vaccine committee to make sure that the science behind the development was well understood and in accord with world regulatory activities.

    She said NAFDAC used different mechanisms to approve the vaccine.

    According to her, the body used reliance, “meaning that a more mature regulatory agency across the globe, we can use that as a basis for our review.”

    She said NAFDAC would get the assessment report, know the peculiarity there, then the COVID-19 committee would get to do their job.

    NAFDAC had earlier in the year approved the use of AstraZeneca vaccines in Nigeria, which was distributed to states.

    The first dose of AstraZeneca vaccines have been administered in Nigeria while administration of the second dose would kick-off in May 2020.

  • NAFDAC alerts Nigerians on effects of hair products containing formaldehyde

    NAFDAC alerts Nigerians on effects of hair products containing formaldehyde

    The National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerians against the use of hair smoothing products containing formaldehyde.

    The agency says the U.S Food and Drug Administration has informed it of the short and long-term effects of formaldehyde exposure in hair smoothing products.

    The alert, No: 006/2021 – Formaldehyde in Hair Smoothing Products, was signed by the Director-General of the agency, Prof. Mojisola Adeyeye, and issued to the News Agency of Nigeria (NAN) in Abuja on Monday.

    It said most hair smoothing or straightening products release formaldehyde gas, a known human carcinogen, as classified by the International Agency for Research on Cancer, into the air during hair straightening or smoothing.

    According to the alert, when formaldehyde is released into the air and is present in the air at level exceeding 0.1 ppm, it can cause serious irritation of the eyes, nose and lungs.

    “It can also cause skin sensitivity or allergic dermatitis,” it read.

    The alert outlined some recommendations for people not to use hair products by themselves at home, except they visited a licensed hair professional in a salon.

    It said hair professionals should be trained to take precautions, such as wearing gloves and safety glasses as well as ensuring proper ventilation when applying hair smoothing products.

    According to the statement, hair professionals must read through the list of components, adding that the U.S Food and Drug Administration discourages individuals from buying hair smoothing products for home use.

    “If you are obtaining from a retailer or purchasing online to utilise, read the required list of ingredients. If there isn’t one, don’t buy the product.

    “If the hair smoothing product lists one of these ingredient names on the packaging: formaldehyde, formalin, or methylene glycol, then it means the product contains formaldehyde or will release formaldehyde.

    “Be aware that not all hair smoothing products contain formaldehyde, which is why you need to read the label to see what is in the product,” the alert urges.

    It advised anyone with a bad experience of hair smoothing solution to stop the usage of the product or service and report the reactions to healthcare provider.

    It encouraged consumers, hair and health professionals to report adverse events or quality problems experienced with the use of these smoothing products to the nearest NAFDAC office.

    It also encouraged consumers to make use of NAFDAC PRASCOR [20543 or 0800-1-NAFDAC (0800-1-623322) TOLL FREE from all networks] or via pharmacovigilance@nafdac. gov.ng to report any adverse effect.

    It said that the public could also report via eReporting platform available on the NAFDAC website www.nafdac.gov.ng or via Med Safety Application, available for download on Android and IOS stores.

  • NAFDAC intercepts truck conveying fake vaccines, unregistered drugs to Warri

    NAFDAC intercepts truck conveying fake vaccines, unregistered drugs to Warri

    The National Agency for Food and Drug Administration and Control (NAFDAC) says it has intercepted a Mercedes truck laden with fake drugs and vaccines along Asaba-Benin road.

    The agency says the truck was heading for Warri, Delta State, to deliver its consignments to 15 drug retail outlets in the oil-rich town.

    In a statement, the agency explained that it intercepted the products through its Investigation and Enforcement (I&E) Directorate, following an intelligence report.

    NAFDAC said: “unregistered, banned and controlled medicinal products” were manufactured at Ogbo-Ogwu Bridge Head market in Onitsha, Anambra State.

    It lists some of the products as tetanus diphtheria vaccine, analgin injection, CSP with codeine cough syrup, mepacrine HCL tablets, diethylcarbamazine citrate tablets, dano tetanus vaccine and artestunate injection.

    According to the statement, Director-General of the agency Mojisola Adeyeye made the revelation in Abuja.

    She reiterated NAFDAC’s determination to ensure that only wholesome medicinal products and other regulated products are available in Nigerian markets for public consumption.

    She further explains that the products were evacuated and inventory taken, while the suspects arrested with cartons containing the products made police statements and were released on administrative bail.

    She, however, warns medicine merchants to always have the general wellbeing of people in the country at heart above other considerations, stressing that there is no longer a hiding place for them if they fail to stop illicit business of circulating dangerous medicinal products that are capable of compromising the health of the Nigerian public.

    The agency names outlets where the drugs were to be delivered, of which 15 are in Warri while one is in Onitsha.

    They outlets are: Pendrix Pharmacy; Samtex Pharmacy; Onos Pharmacy; Chima Patent Medicine Store; Imoson Patent Medicine Store; Sam-C Patent Medicine Store; Sunshine Patent Medicine Store; and Hyunus Patent Medicine Store.

    Others are Chuks Patent Medicine Store; Solomon Patent Medicine Store; Friday Patent Medicine Store; Madam Faithmax Patent Medicine Store; Omas Pharmacy; Evans Patent Medicine Store; Chiyere Patent Medicine Store; and Philo Patent Medicine Store, Bridge Head Market, Onitsha.

  • NAFDAC confirms killer-chemical dealers involved in Kano deaths

    NAFDAC confirms killer-chemical dealers involved in Kano deaths

    The National Agency for Food and Drug Administration and Control (NAFDAC) has apprehended merchants of dangerous chemicals used in adulterated flavoured drinks that led to loss of three lives in Kano State.

    The agency stated that internal investigation revealed that only two of the five flavoured drinks identified in the occurrence were registered by NAFDAC, while three were not on the agency’s database.

    It added that the said chemical did not pass through NAFDAC, as there were no records at the Chemical Evaluation and Research Directorate to suggest that permission was given to anyone to import the chemical into the country.

    It added that internal checks at the Ports Inspection Directorate revealed that the chemical was not imported through the ports.

    It, therefore, warned Nigerians against adding chemicals and additives to food and drinks to enhance taste, stressing that such practices could result in severe illness and even death.

    NAFDAC Director-General Prof. Mojisola Adeyeye, who made these known in a statement signed by the agency’s Resident Media Consultant, Sayo Akintola, yesterday, noted that a preliminary result of the agency’s investigation was submitted to the Kano State Governor, Dr. Abdullahi Umar Ganduje, during her two-day visit to the state on an on-the-spot assessment of the incident.

    Prof. Adeyeye noted with regret that three fatalities were recorded with many people having their health compromised. She stressed that it’s heart-warming to note that all the merchants of the deadly chemicals and additives have been apprehended while further investigation continues.

    Noting that food contamination and poisoning could occur through consuming expired food, the NAFDAC boss added that food poisoning could also occur by preparing food with poorly sourced water and putting cooked food on the shelf for several days or months, or in the refrigerator for too long among others.

    “We are very particular about food additives, about the temperature at which a food can be kept, or about the expiration date of food. If all of these are violated, then there could be food poisoning.”

    Prof. Adeyeye said NAFDAC would be working with Kano State Task force under the Federal Task Force on Counterfeit and Fake Drugs and Unwholesome Processed Foods, which is domiciled in NAFDAC, and the Nigeria Consumers Protection Agency in Kano, to prevent the recurrence of the March 11 incident.

    She said samples of the chemicals and additives that were added while preparing the flavoured drinks for consumption were collected and taken to NAFDAC’s laboratory in Kaduna for testing. She said further testing was conducted at the agency’s central laboratory in Lagos for confirmation.

     

  • NAFDAC alerts Nigerians as US places sanitisers on watch list

    NAFDAC alerts Nigerians as US places sanitisers on watch list

    The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians that the US has placed all alcohol-based hand sanitisers, manufactured in neighbouring Mexico, on its watch list.

    The information is contained in a public alert signed by NAFDAC Director-General, Prof. Mojisola Adeyeye, and issued to newsmen in Abuja on Monday.

    The public alert with No: 001/2021 stated the US Food and Drug Agency (USFDA) had placed all alcohol-based hand sanitisers from Mexico on a countrywide import alert to help stop product falsification.

    According to the alert, the products appear to be in violation of rules from entering the US and that until the agency is able to review the products’ safety they will be on the watch list.

    “The USFDA has seen a sharp increase in hand sanitiser products from Mexico that were labelled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination over the course of the ongoing pandemic.

    “Methanol or wood alcohol is a substance that can be toxic when absorbed through the skin and life-threatening when ingested.

    “Methanol is not an acceptable ingredient in hand sanitiser or other drugs.

    “Under the import alert, alcohol-based hand sanitisers from Mexico offered for import are subject to heightened FDA scrutiny and the shipment may be detained.

    “This marks the first time the FDA has issued a countrywide import alert for any category of drug product,” the public alert said.

    It also disclosed that substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.

    The alert said that all persons using these products on their hands were at risk of methanol poisoning.

    It said that young children, who accidently ingested these products and adolescents and adults who drank these products as an alcohol (ethanol) substitute, were most at risk.

    The alert said that Methanol was not an acceptable ingredient for hand sanitisers and must not be used due to its toxicity

    The alert warned consumers, who had been exposed to hand sanitiser containing methanol and were experiencing symptoms, should seek immediate treatment for potential reversal of toxic effects of methanol poisoning.

    NAFDAC implored importers, distributors, retailers, and consumers to exercise caution and be vigilant to avoid the distribution, sale and use of methanol alcohol-based hand sanitisers.

    It also warned those in possession of methanol alcohol-based hand sanitisers to discontinue the sale or use and to submit the stock to the nearest NAFDAC office.

    NAFDAC encouraged the public to wash their hands often with soap and water for at least 20 seconds.

    According to it, if soap and water are not readily available, the use of an alcohol-based hand sanitiser that contains at least 60 per cent ethanol or 70 per cent isopropanol should be used.

    The agency said it was part of the measures put in place to mitigate the possible risk of spreading the COVID-19 virus by the Nigerian Centre for Disease Control (NCDC).

    NAFDAC, however, encouraged health care professionals, consumers and patients to report adverse events related to the use of any hand sanitiser to its nearest office.

  • NAFDAC unravels cause of strange disease in Kano State

    NAFDAC unravels cause of strange disease in Kano State

    The National Agency for Food, Drugs Administration and Control (NAFDAC) has presented a preliminary result of clinical test it conducted of the substances that caused strange illnesses recently in the state.

    Prof. Mojisola Adeyeye, NAFDAC Director General, presented the findings to Gov. Abdullahi Ganduje, on Wednesday in Kano.

    A statement issued by the Chief Press Secretary to the governor, Abba Anwar, said Adeyeye informed the governor that some of the five substances tested were poisonous.

    She also said two of the five substances were not registered and were brought into the country illegally.

    “Some of those substances are poisonous. When one takes them, he or she would find it very difficult to breath normally. That is close to death.”

    Adeyeye said that the Agency was investigating the matter with all seriousness and had placed the operation of two companies on hold.

    “There are six directorates on the issue, engaged in trying to define coherent and scientific explanation to it. The substances have Citric Acid.

    “We also went to two companies that have the registered substances with them, though their substances are registered, but we still put them on hold to avoid certain things, until after our examination,” she added.

    The director general assured that when the final result is out, they would present it to the state government.

    She commended the State Consumer Protection Council for its unrelenting commitment in fighting the marketing of poisonous substances, fake and counterfeit drugs in the state.

    Adeyeye revealed that agency would establish a Coordinated Wholesale Centre for drugs, and is uilding a state office and a well equipped laboratory in Kano.

    In his remarks, Gov. Ganduje assured that the state government would partner with NAFDAC to keep the state and the country safer and healthy.

    “We appreciate your effort in working hand in hand with us in taming this strange illness in the state.

    “For now the source of those substances are known to the authorities: while we arrested many consignments, we are still combing our markets thoroughly,” he said.

    Ganduje said he was happy that the process of examining the substances was hastened by NAFDAC.

    The governor disclosed that state government is building a drug market at the new Dangwauro Modern market, to sanitise the drug procurement system.

    “The drug market there is almost completed. We have put in place at the drug market, offices of NAFDAC, NDLEA, Customs and Excise, among other relevant agencies.

    “We will not relent in our effort to control the drug market in the state,” he said.

    The NAFDAC boss was accompanied by the agency’s Director of Enforcement and Kano State Coordinator, as well as former President of Pharmaceutical Society of Nigeria, Ahmed Ibrahim-Yakasai, among others.

    The director general also presented an Award of Excellence to the governor for his commitment to the war against drug abuse in the state.

  • NAFDAC warns Nigerians against fake insulin tea for diabetes

    NAFDAC warns Nigerians against fake insulin tea for diabetes

    The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians of an unregistered and fake ‘insulin tea’ for cure of diabetes in circulation.

    NAFDAC also warned Nigerians against buying or taking the tea.

    The advice was contained in a statement signed by the Director General of the agency, Prof. Mojisola Adeyeye on Sunday in Abuja.

    “NAFDAC wishes to notify the public of the circulation of an unregistered and fake product called insulin tea, claimed to reduce blood sugar level and ‘delete’ sugar in the body.

    “Please note that the NAFDAC number shown on the packaging of this product (Nafdac Reg. No. 01-8662) is fake; the insulin tea poses a danger to the health of the public.

    “Members of the public are implored to contact the nearest NAFDAC office with any information concerning the distribution, sale and use of the fake insulin tea,” the director general said.

    Adeyeye also advised consumers to report adverse effects related to the use of regulated products to the nearest NAFDAC office.

    The director general urged Nigerians to report such incidents through the toll free NAFDAC PRASCOR 20543 from all networks and pharmacovigilance@nafdac.gov.ng

    Adeyeye said that Nigerians could also report via the e-reporting platform available on NAFDAC website, www.nafdac.gov.ng.