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Tag: Codeine

  • Codeine saga: Emzor refutes NAFDAC’s closure, says ‘We are still manufacturing’

    Embattled pharmaceutical company, Emzor, on Tuesday insists that only one production site of its firm was shut contrary to claims that the entire company was shut by officials of National Agency for Food and Drug Administration and Control (NAFDAC).

    In a series of tweets on its Twitter handle, Emzor said NAFDAC only sealed its liquid line. It said the rest of its manufacturing operation was going on normally.

    The firm said NAFDAC sealed the line five days after carrying out an inspection on the site. It added that the regulator raised no issues at the time of the inspection, only for it to return later to close the line without explanation.

    The tweet was in reaction to a press statement from NAFDAC that it has sealed off all the production lines of three pharmaceutical companies which were implicated in a BBC documentary on illegal codeine sale in Nigeria.

    “Due to insufficient evidence gathered and apparent resistance to provide needed documents during our inspection on May 2, 2018, at the respective companies in Ilorin and Lagos, respectively, it has become necessary to shut down all the product lines of the three companies – Peace Standard Pharmaceutical Limited, plots 3 & 8, Adewole Industrial Estate, Lubcon Avenue, Ilorin, Kwara State; Bioraj Pharmaceutical Limited, 405 Kaima Road, Ilorin, Kwara State and Emzor Pharmaceuticals Ind. Ltd., Ajao Estate, Lagos. This is to allow for a full and comprehensive investigation. The three companies, therefore, remain closed,” the regulator said.

    Emzor, however, denies the claim.

    The company’s statement reads:

    “NAFDAC have only temporarily sealed one of Emzor’s production sites, the liquid line. The rest of Emzor is still operating as normal. On Wednesday the 2nd of May NAFDAC inspected one of our production sites where Emzolyn with Codeine was made. There were given full access and our complete cooperation, with no issues raised at the time.

    “On Monday the 7th of May, NAFDAC sealed the inspected site without giving us a reason nor an explanation of what the violation of the Good Manufacturing Practice (GMP) Code was and it will be wrong for us to speculate as to the reason why.

    “Emzor continues to make good quality affordable medicines for the Nigerian public and the products are still available to buy. We believe in Emzor Wellocracy, unlimited wellness available to all and affordable by all.”

  • Seun Kuti reacts to FG’s codeine ban

    Following the ban of codeine by the Federal Ministry of Health through the National Agency for Food and Drug Administration and Control, Nigerian Afrobeat musician, Seun Kuti has reacted to the ban.

    The Afrobeat star and socio-political critic said the ban will not affect the supply of the drug.

    According to him:” Igbo has been banned since forever (unjustly) but e still dey everywhere. The reactionary ban of codeine by the FG only means drug dealers will make more money from it. It can’t affect supply.”

    The Minister of Health, Professor Isaac Adewole said the directive became necessary due to the gross abuse of codeine in the country. In its stead, the Minister said cough syrups containing Codeine should be replaced with dextromethorphan which is less addictive.

    NAFDAC was also directed to fully carry out its functions among others: to regulate and control the manufacturing, distribution, and sale of drugs, including inspection at points of entry of drugs, drug products and food for compliance with the new directive.

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  • Codeine ban not because of BBC documentary – FG

    The Federal Ministry of Health said on Wednesday that its decision to ban codeine as a pharmaceutical agent did not follow a report by the BBC that highlighted the danger of the substance.

    Olajide Oshundun, a ministry spokesperson said in a statement that the announcement on May 1 only coincided with the publication of the BBC documentary which started running on April 30.

    “The body of the statement released by the ministry yesterday indicated that a working committee had been constituted by the government and they submitted an interim report,” he said.

    “The memorandum was submitted on April 30 and it was due to that the minister took the step to ban codeine and that is why the statement was issued. It was only a coincidence that the government took action almost immediately after BBC’s broadcast,” Oshundun said.

    “The government did not take action due to the report,” he emphasised. “The action was done as a result of the memorandum.”

    The Committee on the Codeine Control Working and other related Matter Group (CCRWG) was set up on January 23, by the Minister of Health Isaac Adewole in Abuja.

    In February, Oluwatoyin Odeku, a professor of pharmacy at the University of Ibadan who chaired the CCRWG, provided an update about the work of her committee and said codeine addition amongst married women was on the rise.

    The ministry also shared a link holding the memorandum document on its website. The link showed that an immediate ban of codeine was the first of 13 recommendations made by the committee.

    The BBC reported on Tuesday that the ban on codeine came as a result of its story, even though the broadcaster noted that a ministry spokesperson had clarified that the action was the culmination of a long time effort aimed at curbing codeine addiction and its attendant social implications.

    In 2016, an investigation by the Nigeria-based International Centre for Investigative Reporting published a two-part investigation into how codeine and other substantives were threatening a generation of young Nigerians of northern origin.

    The BBC story received widespread mention following its broadcast on Monday, with Senate President Bukola Saraki and Aisha Buhari commending the British broadcaster for its public service endeavour.

     

  • JUST IN: FG bans production, importation of syrups containing codeine

    The Federal Government has banned the production and importation of codeine as active pharmaceutical ingredient for cough syrup preparations to check substance abuse among Nigerians.

    The Minister of Health, Prof. Isaac Adewole, made the decision known in a statement issued by Mr Olajide Oshundun, Assistant Director of Information in the ministry, in Abuja on Tuesday.

    The minister directed the National Agency for Food and Drug Administration and Control (NAFDAC) to ban the issuance of permits for the importation of codeine as active pharmaceutical ingredient for cough preparations.

    He also directed the Pharmaceutical Council of Nigeria, (PCN) and NAFDAC to supervise the recall for labelling and audit trailing of all codeine containing cough syrups nationwide.

    Adewole said government had also banned the sale of codeine containing cough syrup without prescription.

    He said the directive became necessary due to the gross abuse of codeine in the country.

    In this regard, the minister said PCN had been directed to continue enforcement activities on pharmacies, patent and proprietary medicine vendors’ shops and outlets throughout the country.

    He also directed NAFDAC to carry out its functions in compliance with the new directives.

    The minister said cough syrups containing codeine should be replaced with dextromethorphan which is less addictive.

    Dextromethorphan is a cough suppressant used to treat coughing, it is also a drug of the morphinan class with sedative, dissociative, and stimulant properties.

    Adewole said the ministry would ensure collaboration among regulatory agencies for effective implementation of extant laws, regulations, policies and guidelines on codeine control and usage.

    He said the regulatory agencies included NAFDAC, PCN, National Drug Law Enforcement Agency (NDLEA), Nursing and Midwifery Council of Nigeria (NMCN).

    “ These agencies shall work together to increase pharmacovigilance around codeine, tramadol and other related substances of abuse,’’ Adewole said.

    Adewole said the ministry would partner National Orientation Agency (NOA), Nigeria Football Federation (NFF), Football celebrities and other celebrities to drive the national campaign against drug abuse.

    “The ministry shall ensure that drug treatment intervention for victims of substances abuse shall be undertaken across the spectrum of health care delivery system in the country,’’ he said.

    The minister said Civil Society Organisations would be strengthened to deliver effective sensitisation, prevention, treatment and rehabilitation services.

    He renewed the commitment of government to ensure the full implementation of the National Drug Distribution Guideline (NDDG) by Jan. 01, 2019.

    He added that the NDDG would also ensure the closure of all open drug markets penultimate the implementation date of the NDDG that is, Dec. 31, 2018.

  • FG bans codeine importation, production

    The Federal Ministry of Health has directed the National Agency for Food and Drug Administration and Control to ban with immediate effect further issuance of permits for the importation of codeine as active pharmaceutical ingredient for cough preparations.

    The Minister of Health, Professor Isaac Adewole said this in a statement on Tuesday.

    He said that the directive became necessary due to the gross abuse of codeine in the country.

    In its stead, the Minister said cough syrups containing Codeine should be replaced with dextromethorphan which is less addictive.

    He also directed the Pharmaceutical Council of Nigeria and NAFDAC to supervise the recall for labelling and audit trailing of all codeine-containing cough syrups in the country, while he has also banned sales of Codeine-containing cough syrup without prescription across the country.

    He noted that NAFDAC had an emergency meeting with the Pharmaceutical Manufacturers Group to inform them that there is an embargo on all new applications for registration of codeine-containing cough syrups as well as applications for renewal has been abolished.

    The PCN has been directed to continue enforcement activities at Pharmacies, Patent and Proprietary Medicine Vendor’s Shops and outlets throughout the country.

    NAFDAC was also directed to fully carry out its functions among others: to regulate and control the manufacturing, distribution, and sale of drugs, including inspection at points of entry of drugs, drug products and food for compliance with the new directive.

    The Minister stated that the ministry shall ensure collaboration among regulatory agencies namely, NAFDAC, PCN, National Drug Law Enforcement Agency, Nursing and Midwifery Council of Nigeria, for effective implementation of extant Acts, regulations, policies, and guidelines on codeine control and usage.

    ‘Furthermore, these agencies shall work together to increase pharmacovigilance around codeine, tramadol and other related substances of abuse,’ Adewole stated.

  • Consume codeine illegally, go to jail – CPC

    The Consumer Protection Council (CPC) has warned that illegal possession and consumption of codeine related drugs attracts severe sanctions.

    The council said in a statement that dispensing, possessing and consuming expectorants and cough syrups containing codeine and other illegal drugs was criminal and may subject offenders to apprehension, detention and prosecution.

    Mr Babatunde Irukera, the Director-General of CPC, issued the warning in a statement made available to newsmen on Thursday in Abuja.

    The director-general said the warning was issued pursuant to Sections 2(c), (e), and (j), Consumer Protection Council Act 2004.

    Irukera said offenders may be apprehended, detained and prosecuted by the council or the National Drug Law Enforcement Agency (NDLEA), adding that upon conviction, the offender could be sentenced to a term of imprisonment.

    He said CPC had advised that cough medication with codeine should be prescribed, dispensed and administered in an abundance of caution.

    He added that codeine should be administered only in strict compliance with professional medical direction, and in any case not prescribed for, dispensed to, or administered to minors.

    The director-general, however, noted that National Agency for Food and Drug Administration and Control (NAFDAC), while exercising its regulatory functions, said expectorants/cough syrups containing codeine might not be dispensed as non-prescriptive Over the Counter (OTC) medication.

    “As such, it is illegal and a violation of law to attempt to purchase, purchase, as well as dispense any such medication, except exclusively in accordance with prescription by a qualified and legitimate medical practitioner.

    “Any possession, delivery or provision of these medications in the absence of a prescription, or legal acquisition but dispensing to a person other than whom it is specifically prescribed for, is a violation of law,’’ he said.

    He added that the illegal possession of codeine also constitutes drug abuse, and presents significant medical risks including possible injury, risky behaviour, addiction and in extreme cases (especially paediatrics), fatality.

    Irukera said codeine is an opiate and one of many in the opioids family.

    He added that codeine is, therefore, classified as a narcotic substance, although not an illegal drug.

    “Codeine is largely used as a pain reliever and cough suppressant. As such, it is an active ingredient in some expectorants or cough syrups.

    “Codeine is implicated in serious adverse effects when taken with, or contemporaneously with alcohol or carbonated drinks.

    “These methods of mixtures negatively interact and have become a serious and dangerous pattern which pose significant risks of debilitating side effects including respiratory difficulties, nervous system deficiencies and mental impairment,’’ he said.

    He said emerging medical and regulatory preference was to prohibit prescription of cough medication containing codeine to minors because of its properties and propensity to promote addiction and other exposure to illegal drug use.

  • Pharmacists raise alarm over increased codeine abuse by youths

    The Pharmaceutical Society of Nigeria (PSN) on Wednesday raised alarm over the increase in the abuse of pharmaceutical drugs especially cough syrups with codeine.

    The Vice President of PSN, Dr Daniel Orumwense, raised the alarm during the West African Postgraduate College of Pharmacists community awareness campaign on drug abuse, in Surulere, Lagos.

    The campaign had the theme: ”Drug Abuse and Misuse in the Community: A Collective Responsibility for All”.

    Orumwense was represented by Mrs Bukola Paul-Ozieh, a former Chairman, Lagos State Association of Community Pharmacists of Nigeria.

    The vice president noted that drugs altered the biological functions of the body through their chemical functions.

    According to him, such alteration could be beneficial or harmful.

    “Pharmaceutical drugs are meant to heal illness, but unfortunately, their abuse is on the increase, and a common drug abused is cough mixture that contains codeine.

    “The youth have realised that if they cannot get cocaine easily, they can just go to a pharmacy and get a cough syrup with codeine.

    “When it is used frequently without prescription, the person has started abusing the drug, and this will make him to feel `high’ (euphoria),” he said.

    Orumwense said that collaborative efforts of all stakeholders were needed to combat drug abuse.

    He urged the National Drug Law Enforcement Agency and the National Agency for Food and Drug Administration and Control to intensify efforts to control the use of codeine.

    Orumwense listed reasons people abuse drugs to include environmental pressure, curiosity, social media effects and addiction.

    He urged regulatory authorities to monitor drugs markets and called for more public health campaign for the youth.

    Orumwense urged pharmacists to observe their oath of office and called on parents and community leaders to educate children and the youth on the need to avoid drug abuse.

    NAN

  • Nigerians affected by tramadol, codeine through cow meat consumption – Health Minister

    Nigeria’s Minister of Health, Professor Isaac Adewole, has said Nigerians are indirectly affected by tramadol and codeine through the consumption of cow meat.

    Professor Adewole said he was reliably informed that cattle in the country are being fed with the narcotic drugs that contain opium or an opium derivative used to treat moderate to moderately severe pains.

    “Codeine and Tramador are now widely abused in the country; in fact I have just been told that they now give them to cattle, so we are indirectly affected through the meat we consume,” the Health Minister stated at the inauguration of a working group to address the issue of codeine control and other related matters.

    He further stated that he has requested from the Codeine Control and Other Related Matters Working Group (CCRWG) he inaugurated an interim report within six weeks.

    TheNewsGuru reports some of the side effects of tramadol and codeine include increased blood pressure, blurred vision, change in walking and balance, chest pain or discomfort, convulsions (seizures), fainting and loss of memory.

    Other side effects include change in consciousness, decreased awareness or responsiveness, difficulty with breathing, loss of consciousness, severe sleepiness, slow or irregular heartbeat, unusual tiredness, confusion, agitation, hallucinations, unusual thoughts or behavior, and feelings of extreme happiness or sadness.

    “This is not acceptable to us. We must stamp out drug abuse among Nigerians particularly the young ones,” Adewole said.