National Agency for Food and Drugs Administration and Control (NAFDAC) has alerted Nigerians of the recall of one batch of Deekins Amoxycillin 500mg Capsule, manufactured by Ecomed Pharma Ltd and marketed by Devine Kings Pharmaceutical Ltd, with lot number 4C639001.

In a statement released, the agency says the drug batch is being recalled following reports of serious adverse drug reactions.

“According to Ecomed Pharma Ltd, reports of serious adverse drug reactions were received from a hospital that reported three cases of serious adverse drug reactions from patients administered with the batch of Deekins Amoxycillin 500mg capsule,” the statement read.

Amoxicillin is a penicillin antibiotic indicated for treating bacterial infections such as tonsillitis, bronchitis, sinusitis, pneumonia, and bacterial infections of the ear, nose, throat, skin, or urinary tract.

NAFDAC explained that adverse reactions to drugs may be life-threatening, and may require hospitalisation or prolongation of existing hospitalization, result in persistent or significant disability or incapacity, or is a birth defect or death in fatal cases.

The product details of the affected product are as follows: Name: MAH manufactured by Ecomed Pharmaceutical Ltd. Date of manufacturing: 03/2024, Expiry date: 02/2027, and batch number: 4C639001.

The Agency further implored distributors, healthcare providers, and patients to exercise caution and vigilance within the supply chain to avoid distribution, administration, and use of the affected lots of the product.

“All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.

Anyone in possession of the affected lot is advised to immediately discontinue the sale or use and submit stock to the nearest NAFDAC office.

If you have used this product, or someone you know, has used it, or suffered any adverse reaction/event after use, are advised to seek immediate medical advice from a qualified healthcare professional.

Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, or call NAFDAC on 0800-162-3322 or via email: [email protected],” the statement read in part.

NAFDAC further encouraged healthcare professionals and patients to report adverse events or side effects related to the use of the medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website.

Federal Ministry of Health and Social Welfare has dismissed reports regarding the presence of the COVID-19 variant XEC in Nigeria, urging citizens to ignore misinformation circulating on social media.

In a press statement signed by Mr. Alaba Balogun, deputy director of information and public relations at the FMOH, the ministry reassured the public that there is no evidence supporting the detection of the XEC variant in the country.

The statement, titled “Letter of Conveyance in Respect of the Newly Detected COVID Variant XEC,” was issued over the weekend to address growing concerns over false claims.

The XEC variant, first identified in Australia, has reportedly spread to 29 countries and is noted for its increased virulence. However, the ministry clarified that Nigeria remains unaffected.

“We urge the public to stay calm and maintain universal health precautions, including regular handwashing,” the statement read.

To strengthen preparedness, the ministry outlined several measures being implemented to safeguard public health:

– Enhanced Surveillance: Monitoring efforts have been intensified, especially at entry points into the country.

– Improved Healthcare Facilities: Federal tertiary hospitals are equipped with molecular laboratories, isolation centres, and ventilators to manage any potential outbreaks.

– Public Reassurance: Nigerians are encouraged to carry on with their daily activities without fear, as there is no credible threat from the XEC variant.

The ministry also addressed a letter with reference number DHS/INSPDIV/017/VOL.1/46, dated December 5, 2024, which has been widely shared online. They described the letter as fake and urged the public to disregard its content.

“As part of our responsibility to coordinate, monitor, and evaluate response activities, the Federal Ministry of Health remains committed to ensuring uninterrupted healthcare services in the event of any outbreak,” the statement added.

The ministry emphasised its proactive approach to monitoring emerging infectious diseases and reaffirmed its dedication to protecting public health. Regular updates will be provided to keep Nigerians informed of any developments.

The XEC variant of COVID-19 is a recombinant strain, meaning it results from the combination of genetic material from two or more existing variants of the SARS-CoV-2 virus.

Recombinant variants can emerge when different strains infect the same individual and exchange genetic material during replication.

This process may lead to new variants with unique properties, such as increased transmissibility, virulence, or resistance to immunity.

Although the XEC variant has spread to 29 countries, there is no evidence of its presence in Nigeria, as confirmed by the Federal Ministry of Health.

Authorities globally are monitoring the variant closely to assess its impact and ensure that public health measures remain effective.

As countries worldwide commemorate International Human Rights Day, Paradigm Initiative (PIN) is calling for the enactment of robust legal frameworks that uphold human rights online.

The organisation underscores the importance of respecting rights and supporting the development and enforcement of laws in a human-rights-respecting manner in the Global South. These include strong data protection laws that safeguard the right to privacy and legislation governing automated decision-making systems to mitigate potential biases. This, PIN adds, would ensure human rights are realised as the future remains secure.

“Governments should address systemic issues that hinder the enjoyment of human rights and take the necessary steps to support an independent judiciary to ensure the impartial administration of justice and upholding the rule of law,” said Bridgette Ndlovu, the organisation’s Partnerships and Engagements Officer.

This year, International Human Rights Day is commemorated under the theme “Our rights, our future, right now.” The theme focuses on how human rights are a pathway to solutions, playing a critical role as a preventative, protective and transformative force for good. Paradigm Initiative (PIN) also highlighted the crucial role of digital rights in safeguarding human dignity and promoting social justice.

In securing a rights-respecting digital future, the organisation applauded the positive developments throughout 2024 and supported efforts to safeguard human rights online. Countries in the Global South, such as Malawi, Ethiopia, and Syria, made notable strides in advancing digital rights by enacting data protection legislation establishing guidelines for processing, storing, and sharing personal data. Botswana repealed its archaic data protection law and adopted a new Data Protection Act.

Equally, enforcement of data protection legislation gained momentum as countries such as Tanzania, in the case of Safari Automotive Limited vs. Godwin Danda, awarded compensation to the data subject after the automobile company published a video clip of the data subject on social media without consent.

In Kenya, taxi hailers Bolt Operations OU and Bolt Support Kenya were fined for failing to properly handle an incident and escalate it according to established protocols. The incident happened when unauthorised parties accessed a data subject’s Bolt driver account, performed fraudulent trips and altered the data subject’s account details, violating the data subject’s right to access personal data and correct false or misleading data.

In Kenya, data subjects were awarded compensation after offenders were found liable for commercial use of data subjects’ personal data without consent. Angola fined offenders who failed to protect data subjects’ personal data from cyber-attacks. Benin published decisions and resolutions that specify the certification of DPOs, and Brazil published two resolutions that define the activities of DPOs and regulate international data transfers.

In Nigeria, in the case of Folashade Moleshin vs United Bank of Africa, a Paradigm Initiative-supported case, the judiciary handed a judgement in favour of the complainant after a data breach reported on PIN’s Ripoti platform, promoting privacy.

PIN acknowledged the judiciary’s role in adjudicating cases brought before the courts and parliamentary oversight in innovations within the justice system, in particular, in Zimbabwe, where parliament produced an adverse report on the Integrated Electronic Case Management system, citing negative consequences for public participation due to limited access to the internet.

The organisation asserted that human rights online are crucial and legislation should be people-centred and provide robust safeguards for personal data, including measures to prevent unauthorised access and surveillance. Countries such as South Africa, Mauritania, Nigeria, and Zambia published National AI Strategies to safeguard human rights from risks that may arise from automated decision-making.

The African Union Executive Council endorsed the Continental AI Strategy and African Digital Compact at the regional level to set the pace and provide a framework for harmonising laws. At the international level, nations adopted the United Nations Global Digital Compact and countries such as Cote d’Ivoire acceded to the Budapest Convention on Cybercrime. Kenya is also planning to accede to the Convention.

Despite the outlined positive developments, significant challenges remain in the Global South with PIN condemning the actions of countries such as Mozambique, Mauritius, Nigeria, Senegal, Tanzania, Comoros, and Kenya, which shut down the internet this year.

These negative actions undermined human rights, suppressed dissent and had a chilling effect on freedom of expression. Going forward, governments ought to halt the practice of internet shutdowns and uphold the right to free expression so that individuals can freely impart information and engage in political discourse in line with the ideals set out in the Universal Declaration of Human Rights, adopted by the United Nations General Assembly in 1948.